WCG Talks Trials: Recent Episodes
WCG
Study start-up remains one of the most persistent bottlenecks in clinical trials—slowing site activation, delaying patient enrollment, and adding pressure across already stretched teams. In this episode of WCG Talks Trials, host Jamie Harper, Vice President of Site Solutions & Engagement at WCG, is joined by Stephanie Held, Associate Director of Coverage Analysis, and Jody Ingebritsen‑Howe, Director of Contracts & Budgets, to unpack why start-up timelines continue to stall and what can be done to improve them.
Together, they explore how Medicare Coverage Analysis (MCA) serves as the foundation for compliant and efficient study start-up, how downstream processes like budgeting, contract negotiations, and CTMS build are impacted by early decisions, and where “hidden” white space can quietly derail timelines.
The conversation also highlights practical, actionable steps sites and sponsors can take today—from mapping end‑to‑end workflows to better equipping negotiators with the information they need.
Looking ahead, the panel discusses how technology and AI may reshape study activation, while emphasizing the importance of human expertise and alignment across teams. Whether you’re a site, sponsor, or CRO, this episode offers timely insights to help accelerate activation and reduce friction in an increasingly complex trial landscape.
Host:
Jamie Harper, vice president, Site Solutions & Engagement
Guests:
Stephanie Held, associate director, Coverage Analysis
Jody Ingebritsen-Howe, director, Contracts & Budgets
Clinical trial complexity is rising with more procedures, endpoints, and technology, yet sites are turning these pressures into pathways for improvement. In this episode of WCG Talks Trials, host Jenna Goeller sits down with Trevor Cole to unpack practical ways research sites sustain readiness, build resilience, and spark innovation amid frequent protocol amendments and technology overload. Together, they explore what’s changing on the ground and how sites are responding with stronger feasibility reviews, capacity planning, streamlined protocol advocacy, and risk‑proportionate oversight – all grounded in Quality by Design and the updated ICH E6(R3) guidance.
Listeners will hear data‑driven insights on:
- The operational ripple effects of complexity, including resource strain, rework from amendments, and tech support burdens, and what’s working to reduce them.
- Day‑to‑day applications of risk‑based quality management, data governance, and proportionality to protect participant safety and data integrity.
- Culture and maturity for empowering teams, mapping processes before SOPs, continuous training, Correction and Preventive Action (CAPA) discipline, and knowledge sharing across silos.
- How sponsors and CROs can better support sites through integrated technology, protocol simplification, early collaboration, and transparent communications.
- Turning complexity into growth by investing in people and processes, using fit‑for‑purpose tech (including selective AI use), and engaging local communities.
Speakers:
Jenna Goeller, Associate Director, Clinical Trial Insights & Analytics, WCG
Trevor Cole, Program Director, Clinical Solutions & Partnering, WCG
In this episode of WCG Talks Trials, host Gabriella Tost sits down with Latin America regional experts Mercedes Lopez, Camila Santos, and Sebastian Florez to explore how artificial intelligence, telemedicine, and wearable technologies are reshaping clinical research across Latin America. From expanding access through virtual care to empowering patients with biosensors, the conversation highlights how digital tools are breaking longstanding barriers to participation — especially for rural and underserved communities.
The group dives into the growing role of AI in participant identification, site selection, and overcoming fragmented health records — challenges historically unique to the region. They also discuss rapid regulatory modernization in countries like Brazil, Mexico, and Ecuador, which is accelerating approvals, enabling decentralized trials, and fostering a fertile environment for global investment.
Looking ahead, the experts paint an exciting picture of what research will look like by 2026: connected data ecosystems, hybrid study models, stronger community engagement, and more inclusive recruitment than ever before. Whether you're a sponsor, site, or technology innovator, this episode offers clear insights into why Latin America is becoming a global leader in digital-forward, participant-centered clinical trials.
For more into these insights, read their article, “AI and the Digital Future of Health in Latin America: A Sponsor's Opportunity,” in the 2026 Trends & Insights Report.
In this episode of WCG Talks Trials, Sandy Smith, Sylvia Baedorf Kassis, and Dr. Donna Snyder discuss the critical role of health literacy in clinical research. They explore how clear communication can enhance patient understanding and engagement, the importance of a common language in research, and the introduction of the MRCT Center’s Clinical Research Glossary as a tool to facilitate better communication. The conversation emphasizes the need for consistent terminology and the integration of health literacy practices in clinical research to improve participant experiences and outcomes.
Key highlights:
- Health literacy is crucial for effective communication and participant engagement in clinical research.
- The MRCT Center’s Clinical Research Glossary helps simplify complex terms into plain language, supporting understanding for all stakeholders.
- Consistent terminology and clear communication empower participants, improve data accuracy, and enhance patient advocacy.
- Integrating health literacy practices leads to better retention and experiences for trial participants.
Host:
Sandy Smith, RN, MSN, AOCN, senior vice president, clinical solutions & strategic partnering, WCG
Guests:
Sylvia Baedorf Kassis, MPH, program director, Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard
Donna Snyder, MD, MBE, executive physician, WCG
In this episode of WCG Talks Trials, Cristin MacDonald, Doug Mayer, and Tyler Bye discuss how Software as a Service (SaaS) solutions are democratizing the clinical trial landscape. Learn how SaaS platforms are enabling organizations of all sizes to leverage cutting-edge technology, improving collaboration, standardization, and data security throughout the clinical research process. The team shares the benefits of adopting SaaS, practical insights for successful implementation, and highlights the pivotal role of technology partnerships in supporting innovation and research efficiency. Tune in to discover how your organization can optimize clinical trials and accelerate research impact with SaaS technology.
In this episode of WCG Talks Trials, Silvio Galea, chief data and analytics officer, and Bryan Wayne, vice president of imaging operations, both of WCG, explore the critical role of imaging in clinical trials. Together, they break down industry acronyms, unpack the process of independent image review, and discuss how WCG is contributing to the validation and implementation of AI-driven radiology solutions. Listen in as they share behind-the-scenes insights into core lab operations, the significance of sample size and study design, and how emerging technology is shaping the future of clinical research. Whether you are a clinical trial professional, healthcare innovator, or simply curious about the intersection of AI and research, this episode provides valuable perspectives on driving efficiency, accuracy, and better outcomes in clinical research imaging.
For more information about WCG’s imaging solutions, visit wcgclinical.com/imaging.
In this episode of WCG Talks Trials, Sandy Smith, senior vice president, clinical solutions & strategic partnering, WCG, is joined by Tiffany Pierce, director, clinical trials core, Henry Ford Health System, to discuss resilience in clinical research.
As the landscape of clinical trials faces evolving challenges, they explore how organizations and institutions, like Henry Ford Health, are addressing disruptions, uncertainties, and changes at the federal level. Learn about innovative strategies to enhance trial efficiency, including role clarity, flexible workflows, and diversifying research portfolios.
With a focus on maintaining forward momentum in trials and remaining nimble, they discuss actionable solutions to administrative burdens and enhance the efficiency and speed of trial completion. This episode offers invaluable guidance for professionals seeking to stay agile and adapt to ongoing changes in the clinical trials.
HOST: Sandy Smith
SPEAKER: Tiffany Pearce
Dive into the world of generative AI with Silvio Galea, chief data analytics officer, WCG, and Kyle Miller, lead data scientist, WCG. In this compelling episode of WCG Talks Trials, we explore how Generative AI can improve clinical research workflows from meticulous data entry to efficient data validation. Uncover the technology behind AI’s ability to assist in document updates, highlight transcription biases, and digitize complex data for predictive analytics. Understand the importance of human oversight and practical applications that can optimize how clinical trials are conducted. Whether you’re curious about AI’s role in reading dense documents or leveraging pipelines for innovation, this episode provides the insights you need.
Guests:
Silvio Galea, chief data and analytics officer, WCG
Kyle Miller, lead data scientist, WCG
In this episode of WCG Talks Trials, join Silvio Galea, chief data and analytics officer, WCG, and Melissa Hutchens, vice president of research and benchmarking, WCG, as they discuss the transformative role of AI in clinical trials. Discover how generative AI and other AI technologies are enhancing the quality of clinical trials, reducing cycle times, and cutting costs. The episode covers the benefits, barriers, and concerns associated with AI, and explores its applications in drug discovery, participant recruitment, trial design, and more. Tune in to learn about the latest advancements in AI and how they are shaping the future of clinical trials.
Guests:
- Silvio Galea, chief data and analytics officer, WCG
- Melissa Hutchens, vice president of research and benchmarking, WCG
Join us for "Breaking Down Site Complexities and Start-Up Barriers in Clinical Trials" as we uncover the complexities of site management and the barriers to effective study start-ups. Discover the top issues impacting research sites and strategies to overcome them, including trial complexity, start-up hurdles, and long initiation timelines.
Learn how effective communication, teamwork, and clear processes can drive success, and the importance of human connections and inclusivity in clinical research. Get practical advice for improving site readiness and trial efficiency from our expert guests.
Don't miss this essential episode on navigating the evolving clinical trial landscape at sites.
Guests:
Jessica Thurmond, program director, WCG
Pat Harrington, senior vice president, Clinical Solutions & Strategic Partnering, WCG
Brad Gruener, vice president, Site Services, WCG
Join us for a compelling episode of WCG Talks Trials where we take a look into the rewarding world of clinical trials and clinical development. In this episode, George Cokenakes, director of clinical services, review solutions, WCG, speaks with Dr. James Januzzi, a renowned cardiologist at Massachusetts General Hospital, and chief scientific officer at Baim Institute for Clinical Research. Dr. Januzzi shares his inspiring journey, highlighting the significance of clinical trial participation and the diverse opportunities that can shape a medical career.
Learn from Dr. Januzzi's extensive experience in clinical research, including his work on cardiac biomarkers, drug therapy development, and involvement in various therapeutic areas. Discover how career decisions and active engagement in clinical trials can open doors to numerous possibilities and significantly impact patient care.
Tune in for this insightful conversation and gain valuable advice for budding clinicians and researchers.
Speakers:
George Cokenakes, PMP, director of clinical services, review solutions, WCG
James Januzzi, MD, FACC, cardiologist, Massachusetts General Hospital and chief scientific officer, Baim Institute for Clinical Research
In this episode of "WCG Talks Trials," host Geoffrey Schick, director of strategic site partnerships, WCG, is joined by fellow MAGI@home 2024 speakers Sandy Smith, Jess Thompson, and Wesley Warren. They share their unique perspectives and key takeaways from this year's virtual conference, including discussions on contract negotiations, the evolving role of advanced practice practitioners, and the collaborative panels featuring both site and sponsor/CRO insights. The episode also recaps the impactful session on the FDA's Diversity Action Plan and what it means for the future of clinical trials. Tune in to hear about the dynamic energy, valuable connections, and innovative challenges that make MAGI and MAGI@home standout events in clinical research. Don't miss out on the exciting plans for MAGI 2025 in Boston, where trends will continue to evolve and new opportunities will emerge.
Guests:
- Geoffrey Schick, MBA, CHRC, Director of Strategic Site Partnerships, WCG
- Sandy Smith, RN, MSN, AOCN, Senior Vice President, Clinical Solutions & Strategic Partnerships, WCG
- Jess Thompson, MS, MBA, PMP, Founder, ACRPM.org
- Wesley Warren, J.D., Executive Director, Research Strategy & Partnerships, City of Hope
In this episode of WCG Talks Trials, host Sandy Smith, senior vice president of clinical solutions and strategic partnering at WCG, dives into the highlights of the Florence Healthcare Research Revolution event. Sandy is joined by industry experts Andrea Bastek, vice president of innovation at Florence, and Lauren Sobocinski, senior vice president of strategic alliances at WCG, to discuss transformative insights from the event. Discover the latest trends shaping clinical research, including site engagement, protocol complexity, and effective sponsor-site relationships. Tune in for a compelling discussion on how collaborative efforts and innovative technologies are driving positive change in the clinical trial landscape.
In this episode of WCG Talks Trials, host Kelly FitzGerald sits down with Dr. Currien MacDonald, Medical Chair Director at WCG, and Sara Reed, a participant in two psychedelic clinical trials, to explore the evolving landscape of psychedelics research. Dr. MacDonald shares his expertise on the growing acceptance of psychedelics in clinical settings, recent FDA updates, and the inner workings of ongoing trials. Later, Sara provides a firsthand account of her experiences as a trial participant, offering unique insights into how psychedelics are being tested as potential therapeutic options. Tune in to learn more about aligning clinical practice with patient experience in this emerging field.
In this episode of WCG Talks Trials, Geoff Schick, director of strategic site partnerships, joins our host Sandy Smith, senior vice president of clinical solutions and strategic partnering, to discuss the expansion of research site cancer portfolios.
Join Desiree Underwood-Williams, director of project management organization at WCG and guest Steve Smith, CEO of SteveSmithPlans LLC and facilitator of the WCG Patient Forum, as they recap the latest Patient Forum Focus Session on breakthrough science and community engagement. Discussion highlights include:
- The impact of medical diagnoses on families with Sickle cell disease and melanoma.
- New research in cell and gene therapy that’s directly impacting Sickle cell disease and melanoma patients.
- New diversity laws shaping the future of drug development.
- Community engagement and how patients can get involved in their care.
- And more insights into the WCG Patient Forum, now in its fifth year.
Tune in to learn more about clinical research, community engagement, and the latest developments in patient care.
In this episode of WCG Talks Trials, we are joined by host Joanne Thomas, clinical reviewer and patient advocate at WCG, along with our guest Currien MacDonald, medical chair director at WCG. This episode covers the roles of IRB in ethical clinical research, frequently asked questions, and a general overview of the IRB’s role in clinical trials.
This episode of WCG Talks Trials addresses site feasibility challenges impacting the clinical trials industry. Join Michelle Yu, associate director of clinical strategy at WCG, and our guest Trevor Cole, director of client delivery, site and strategic operations for WCG, as we discuss approaches to adopt innovative feasibility and site start-up solutions.
Here are links to documents referenced in this episode:
Main Article: Recommendations to Streamline and Standardize Clinical Trial Site Feasibility Assessments: An ASCO Research Statement
PDF Data Supplement: <a href="Recommendations to Streamline and Standardize Clinical Trial Site Feasibility Assessments: An ASCO Research Statement
Join our Chief Analytics Officer Silvio Galea, along with Dr. Donna Snyder & Dr. Barbara Bierer to discuss opportunities on the ethical and regulatory challenges regarding artificial intelligence in clinical trials. The discussion is focused through the lens of the IRB review, and how a multi-stakeholder task force led by the MRCT center and WCG will address the growing need for guidance in this rapidly evolving area of research.
In this episode of WCG Talks Trials, we are joined by WCG clinical science experts as they discuss traditional measurement challenges for PTSD trials and how the use of an electronic CAPS-5 scale is improving administration and scoring errors.
Tune in as we discuss the CAPS-5 scale, the opportunities and benefits of using an electronic version to help standardize scale administration and scoring across clinical research, and the promising results to date.
In the most recent episode of WCG Talks Trials, we are joined by three industry experts, Amy Thue and Shelby Ward from WCG, and Russell Lampman from Merck to discuss the topic of optimizing vendor support, and ultimately the success, of clinical trials.
Listen in as we dive into feedback and perspectives from both the sponsor and vendor side of the table—for valuable take-aways and insights into how vendor support is best aligned across all stakeholders.
In Part 2 of this discussion, Currien MacDonald, MD, CIP Medical Chair Director for WCG's IRB, discusses new FDA regulations for waiver of consent with Kelly Fitzgerald, PhD, WCG's IRB Executive Chair and VP IBC Affairs.
In Part 1 of this discussion, Currien MacDonald, MD, CIP Medical Chair Director for WCG's IRB, discusses a policy change that is going into effect for WCG IRB with Lindsay Abrahams, Regulatory Chair Director.
Lindsay and Currien discuss the concise summary and its application to consent forms, especially for WCG.
In this episode of WCG Talks Trials, our expert panel discusses various ethical, safety, and logistical challenges in accelerating clinical trials for gene and cell therapies in oncology. The conversation explores the role of Institutional Review Boards (IRBs), Institutional Biosafety Committees (IBCs), Endpoint Adjudication Committees (EACs), and Data Monitoring Committees (DMCs) in overseeing these trials, addressing issues such as patient safety, complex trial designs, and emerging biosafety concerns. Our panelists emphasize the importance of transparent communication and collaboration between IRBs and IBCs, highlighting the need to balance the urgency of advancing research with ethical considerations. Additionally, the podcast explores unrealized ethical and safety issues, such as the pace of technological advancements and potential risks associated with gene editing. The speakers also touch upon future opportunities in oncology research, including precision medicine, artificial intelligence, wearable devices, and accelerated regulatory pathways.
In episode 10 of WCG Talks Trials, we are joined by Catherine Gregor, the Chief Clinical Trial Officer at Florence Healthcare, to discuss Florence’s recent Research Revolution event and the importance of site enablement in clinical research. Listen in as we recap Research Revolution, share insights on emerging clinical trial trends and innovations, and have a candid conversation about what stands in the way of successful site enablement in clinical research.
In this episode of WCG Talks Trials, we are joined by Elizabeth Weeks-Rowe, CCRA, author of The CRA’s Guide to Monitoring Clinical Research, 6th Edition.
Led by WCG Director of Publications and Content, Leslie Ramsey, the discussion will delve into the ways the clinical trials industry has become more complex and technologically focused and the challenges clinical research associates (CRAs) face as monitors of clinical trials.
Host: Leslie Ramsey, Director of Publications and Content, WCG
Participant: Elizabeth Weeks-Rowe, Independent Clinical Research Consultant
In this episode of WCG Talks Trials, we are joined by MAGI@home Steering Committee members, Jennifer Peterson, Director, Head of Clinical Quality at M3 Wake Research, and Geoffrey Schick, Director, Strategic Site Partnerships at WCG.
Led by Carmin Gade, Chief Marketing Officer at WCG, the discussion will delve into the insights and value MAGI events provide that enable attendees to achieve success in their roles and professional development.
This episode of WCG Talks Trials, hosted by Kelly Fitzgerald, Executive IRB Chair and Vice President of IBC Affairs at WCG, dives into the topic of diversity and inclusion with technology in decentralized clinical trials (DCTs). The episode explores the transformative opportunities that DCTs present for addressing diversity gaps in clinical research. The discussion features a panel of experts, including Otis Johnson, former Chief Diversity, Inclusion, and Sustainability Officer at Clario; Archana Sah, a seasoned clinical development leader with a focus on oncology and healthcare technology; and Ken McCann, a physician with a background in pediatrics and a keen interest in social determinants of health. The panelists share insights on how DCTs can improve accessibility, overcome barriers, and enhance representation in clinical trials, emphasizing the potential for these trials to be a game-changer in making clinical research more equitable and inclusive.
Guests:
- Archana Sah MS (Pharm.) PMP
- Otis Johnson, PhD, MPA
- Ken McCann, MD
Listen to the latest episode of WCG Talks Trials to hear from experts on the importance of patient advocacy in clinical research and key takeaways from WCG's 2023 Patient Forum. We'll summarize how the patient forum elevates the voices of those changing drug development for the better and recap breakthroughs and best practices shared during the most recent event.
Discover more about patient and researcher collaboration, expanding diversity, equity, and inclusion in trials, and the latest advocacy-driven technology, science, and policy breakthroughs leading to modernized clinical research.
Guests:
- Desiree Underwood-Williams, PMP, CLSSBB, Director, Project Management Office, WCG
- Steve Smith, President, Patient Advocacy, WCG
Listen to the latest episode of WCG Talks Trials to hear from experts on the importance of diversity, equity, and inclusion in clinical research and how intersectionality plays a role in promoting DE&I. We'll discuss why diversity is pivotal for comprehending the full spectrum of clinical care mechanisms and review effective DE&I strategies being deployed today. Discover how communities can be more actively engaged in clinical research and hear real-world examples of success stories in promoting diversity, equity, and inclusion within clinical research.
Moderator:
- Scott J. Hunter, PhD - Senior Scientific Expert, Neurodevelopmental and Rare Pediatric Diseases, WCG
Speakers:
- Sonya Dinizulu, PhD - Associate Professor of Psychiatry and Behavioral Neuroscience, University of Chicago
- Desiree Underwood-Williams, PMP, CLSSBB – Director, Project Management Office, WCG
Join WCG Talks Trials podcast host Kelly Fitzgerald, PhD, in a riveting dialogue with guest expert Currien MacDonald, MD, as they unravel the nuances of "Psychedelics in Research: Ethical and Medical Perspectives."
Dr. MacDonald, with a solid foundation in family medicine and clinical trials administration, guides listeners through a grounded exploration of psychedelic substances. In this episode, they demystify the realm of psychedelics, encompassing both dissociative and classic varieties, such as LSD and MDMA.
As the conversation delves into ongoing research, the potential applications of these compounds in treating mental health challenges like depression, anxiety, and post-traumatic stress disorder come to the fore. The dialogue doesn't shy away from probing the ethical dimensions surrounding psychedelic research, addressing concerns about study design, potential abuse, and the intricate balance between benefits and risks. This insightful podcast offers an engaging journey into the evolving field of psychedelic research, shedding light on its medical potential and the ethical considerations that guide its path.
In episode three of WCG Talks Trials, two WCG experts discuss key findings from the 2023 Avoca State of the Industry Report, which provides a 360-degree view on motivators and deterrents to clinical trial participation.
Listen in as we dive into feedback from perspectives across all clinical research stakeholders — sponsors, providers, sites, and patients — for valuable take-aways and insights into the trial experience.
Speakers:
Crissy MacDonald, PhD,Vice President, Client Delivery, WCG Avoca
Gina DiCindio,Associate Director, Industry and Client Research, WCG Avoca
In episode two of WCG Talks Trials, we are joined by two WCG experts to discuss overcoming common enrollment challenges and how DE&I, technology, and protocol design factor into enrollment success.
Listen in as we delve into the critical topic of common enrollment barriers in clinical trials, how to improve enrollment by focusing on DE&I efforts, the importance of site-centric and patient-centric technologies, and how thoughtful protocol design plays a significant role in enrollment success.
Podcast Guests:
- Jamie Harper, MHA, CCRP - Vice President, Site Solutions & Engagement at WCG
- Tyler Bye - Director, Site Solutions & Product Strategy at WCG
In the first episode of our new podcast series, WCG Talks Trials, we are joined by three industry experts, Lisa Ballance from Virginia Commonwealth University, John Musser from Florida Cancer Specialists and Research Institute, and Dan Otap from Genentech, to discuss the topic of overcoming site challenges and addressing site burden.
Listen in as we discuss the results of WCG’s recently published 2023 Clinical Research Site Challenges Survey Report, gain insights from our guests on solutions their organizations have implemented to reduce site burden, and share perspectives on how sites, sponsors, and CROs can work to improve site and trial efficiency.
Speakers:
- Sandy Smith, RN, MSN, AOCN
Senior Vice President, Clinical Solutions and Strategic Partnerships at WCG Clinical - Lisa Richman Balance
Associate Vice President for Research Strategy and Regulatory Affairs at Virginia Commonwealth University - John Musser
Senior Director, Clinical Research Administration at Florida Cancer Specialists & Research Institute - Dan Otap
Principal, Alliance and Partnerships Lead at Genentech
From a career devoted to finding better ways to connect patient volunteers to clinical trials, Lisa LaLuna knows why the public needed an online search tool that is easier to use than the traditional methods of access.
“Members of the public often want to find a trial to access the latest medicine, or help a family member, or just to participate as a healthy volunteer to further medical research. Pharmaceutical companies that run clinical trials of course want to enroll patients so their research can be successful. In spite of this mutual desire to work together, patients and trial organizers often cannot find each other,” Lisa explains.
Some trials are stopped because they cannot enroll enough people and others are delayed because enrollment takes too long. In this unfortunate scenario – one that happens too often – this slows down the development of treatments and cures that patients depend on.
Lisa explains the importance of this search tool in providing a simple, fast way to discover trials specific to a disease, a location, and the personal characteristics of volunteers being sought.
“You can even opt in to be notified when more trials are posted, and send a message to the local trial site to request contact to learn more and possibly be screened for qualification purposes. “ Lisa explains.
This free website can be found by anyone at centerwatch.com/clinical-trials.
Visitors to the site will find basic information about what a clinical trial is and why someone would want to participate.
Patient Advocacy groups are providing this website to their members to educate them about the value of clinical trials and where to find them, in order to support the search for cures. Patient groups like the Michael J. Fox Foundation for Parkinson’s Research, the Alzheimer’s Association, and the rare disease group The Rett Syndrome Foundation are enthusiastic about how their use of this tool is helping them help their communities of patients and their families.
“Clinical trial search tools have been too complicated in the past and we sought to create a tool that is simple and fast so anyone can use it,” Lisa explains. “Seeing the adoption by Patient Advocacy Groups is most satisfying.”
Lisa LaLuna of WCG Patient Advocacy has thirty years working in clinical trials and is a passionate advocate for easing the search for trials for those wishing to volunteer.
Bernadette Siddiqi, associate director of research partnerships at The Michael J. Fox Foundation for Parkinson’s Research talks about how they give members of the public access to the Fox Trial Finder. This clinical trial search tool that allows anyone to search for Parkinson’s disease clinical trials. More than 300 are listed on the site.
It’s a bottleneck in clinical research. Patients are eager for a cure, but it can be difficult for them to connect to trials and for researchers to connect to volunteers.
Bernadette speaks of why it is critical to the foundation’s mission to provide an easy way to make this connection. Just as important, she says, is educating people about research. Fox Trial Finder provides both. Roughly 700 people visit the site each month.
The Fox Trial Finder is powered by CenterWatch iConnect, and The Michael J. Fox Foundation for Parkinson’s Research is part of growing list of patient advocacy groups that deploy this search tool to inform and empower their patient community.
The Michael J. Fox Foundation for Parkinson’s Research is dedicated to finding a cure for Parkinson’s disease through an aggressively funded research agenda.
After more than 25 years working to plan and conduct clinical trials at pharmaceutical companies, Ros Cheetham decided to put herself into the patient role: She volunteered to participate in a COVID vaccine clinical trial.
She discusses why she decided to participate in the trial and shares her experiences. So far, it’s all been positive: She speaks of modern methods, safety and the well-organized approach and thoughtful communications used by the clinical research site.
She also talks about the barriers, such as distance, that prevent some people from participating in clinical trials, and calls on the industry to help potential participants to overcome those barriers. Studies must be as inclusive as possible so clinical research can benefit a more representative cross-section of our society.
She also exhorts individuals to, like her, become clinical trial volunteers. Trials need volunteers, and everyone should have the experience of being in a clinical trial.
Cheetham is a pharmaceutical development professional providing expertise in global drug development, global clinical operations solutions and partnership and alliance strategy. Her broad industry experience encompasses several vice president positions. She has led product development teams through successful filings and commercialization of new drugs as well as having implemented innovative global operational solutions that provided cost savings with timely execution and high quality.
Movement disorder trials have always been demanding. Now, sponsors face an additional challenge: How do you ensure data integrity in the era of remote clinical trials? In this podcast, Bob Dagher, MD, WCG MedAvante-ProPhase’s Chief Medical Officer, addresses this in conversation with Steve Smith, WCG President of Patient Advocacy. This is the fourth episode in our series, “Transforming CNS Trials During COVID-19—and Beyond.”
Sponsors planning to restart movement disorder programs need to be clear-eyed and realistic, Dagher counsels. “When it comes to remote assessments, we have to be vigilant and aware of what we can do and also about what we really cannot do.” Some assessments simply cannot be performed remotely. This means sponsors will need to figure out how to account for variability and missing data in their statistical plan before locking the database.
FDA guidance on the conduct of trials during COVID-19 helps provide a roadmap. For example, in the case of anticipated missing data the guidance clearly states to capture specific information in the case report form that explains the relationship to COVID-19.
But it also requires in-depth scientific and clinically-informed knowledge so that the quality of the data captured isn’t sacrificed as direct result. Accordingly, WCG has been working with clients to tailor remote assessments for sponsors’ trials, yielding assessments that are as close as possible to the in-person versions (minus those particular items that cannot be done remotely).
Dagher’s message? “Ensuring data integrity at every step of the process should be the primary guide for any decision-making process when deciding to restart your study.”
Prior to joining WCG MA-PP, Dr. Dagher, was the Chief Medical Officer of Cadent Therapeutics in Cambridge, Mass. Before that, he served in many leadership roles at small and large biopharmaceutical and clinical research organizations, including GlaxoSmithKline, Genzyme, Sanofi and Covance, among others. Dr. Dagher has fostered the development of multiple products in different indications and development platforms and advanced several small molecules and biologics across all stages of clinical development. His background includes therapeutic experience in psychiatry, neurology and rare diseases.
As a global strategist for Intel’s Health and Life Sciences Group, Bryce Olson had an up close view of innovation happening in the lab—especially in terms of genomic sequencing and gene therapy. As a man diagnosed with aggressive stage 4 prostate cancer at 44, he had as well an up close view of how that innovation was not being translated into the clinic.
He was started on a one-size-fits-all standard of care. It didn’t work, and chemo made him ill. In this podcast episode, he talks about how he demanded—and received—DNA sequencing. That data led him to find the right trial and the right medicine for his type of prostate cancer.
He’s now a very vocal advocate of sequencing. Among other endeavors, he founded Sequence Me (www.sequenceme.org), a patient-driven movement to accelerate access and adoption of new genomic sequencing innovations for cancer.
In major depressive disorder, researchers have used remote assessments for decades. As a result, many of these studies have had an easier time adapting to the new clinical trial landscape. But that doesn’t mean they are pandemic-proof.
So what are the critical success factors for clinical depression programs—especially now?
In his conversation with WCG President of Patient Advocacy Steve Smith, Mark Opler, PhD, MPH, Chief Research Officer at WCG MedAvante-ProPhase offers his insights on the future of clinical depression trials. This is the third episode in our podcast series, “Transforming CNS Trials During COVID-19—and Beyond.”
We’re headed in the right direction by enabling more patient-friendly evaluation, but – especially in light of the pandemic – we must continue to refine these systems and make sure that we have the input of patients, caregivers, and of course, investigators.
Among his recommendations: Ensure clinicians have the right depression-assessment tools and that they are using them correctly.
It’s also critical, he says, to have a solid remote assessment methodology in place. This means not only incorporating the right tools, but also establishing a way of continuously protecting data quality, such as WCG's Study Insight Analytics Platform.
Mark Opler, PhD, MPH, is Chief Research Officer at WCG MedAvante-ProPhase. Dr. Opler was the founder of ProPhase and served as its CEO and Chief Scientific Officer, among other roles. He serves as adjunct assistant professor of psychiatry at New York University and assistant professor of clinical neuroscience at Columbia University’s College of Physicians and Surgeons. He is also leading the development of the forthcoming edition of the PANSS Manual.
LaTasha Lee, PhD, MPH’s path to becoming a sickle cell disease (SCD) researcher and policy advocate began as a child. Because the SCD trait ran in her family, she became a patient advocate while still small. Today, she is Vice President, Social and Clinical Research & Development, at the National Minority Quality Forum. In this wide-ranging interview, she touches on an array of issues affecting the SCD community. Among them: adult patients who end up in the emergency room, the increased number of available therapeutics and the robust pipeline of SCD therapies.
Of particular concern is the challenge of accessing pain medication — both in the ER and in primary care practices. “Individuals with this disease often aren’t believed. They are considered drug seekers when they aren’t.”
She also makes a passionate call for increased minority participation in healthcare and in research to enhance equity and improve outcomes.
Dr. Lee is responsible for the oversight and implementation of research projects and programs focused on reducing patient risk and identifying optimal care to reduce health disparities and bring about health equity at the National Minority Quality Forum. Before that, she served as Senior Manager of Partnership Engagement of the Sickle Cell Disease Clinical Trials Network (SCD CTN) at the American Society of Hematology (ASH) Research Collaborative. She was responsible for establishing, implementing and maintaining effective partnerships with stakeholders including patients, academic medical centers, other clinical research sites, industry, and federal agencies regarding their interests in SCD CTN. As an experienced research manager at ASH she was tasked with the development of a patient engagement strategy and clinical trials network for SCD. While at ASH, Dr. Lee was also responsible for the day-to-day management and implementation of projects, programs and activities related to ASH’s Call to Action on Sickle Cell Disease.
At 51, Jeffrey Borghoff was diagnosed with Alzheimer’s disease. What would devastate many people turned Borghoff into an advocate. The former software architect and developer is now a national spokesperson for the Alzheimer's Association and board member of the Greater New Jersey chapter.
In this podcast, he talks about how the diagnosis forced him to reprioritize his life. “I've been pretty successful at that. I've been leading a very purposeful, engaging, joyful life.” With his care partner—his wife, Kimberly—he travels around the country making the case for research funding—and for clinical trial participation.
That’s critical because important Alzheimer’s trials focus on younger-onset AD patients. Unfortunately, many people who are beginning to show signs at a very young age want to deny they have the disease. They won’t go into trials or even get a diagnosis. His messages to them: This disease does not define who you are, and research is important.
Remote assessments have become a necessity across CNS trials, but some areas are more complicated than others. Schizophrenia provides one such example; the risk of variability is high, and sponsors are concerned. In this podcast, Mark Opler, PhD, MPH, Chief Research Officer at WCG MedAvante-ProPhase, sits down with WCG President of Patient Advocacy Steve Smith to discuss the topic. This is the second episode in our podcast series, “Transforming CNS Trials During COVID-19—and Beyond.”
PANSS—the gold standard rating scale for schizophrenia primary outcomes—is based largely on face-to-face interviews; it wasn’t developed for remote assessments. Is it still usable? Yes, says Dr. Opler. “I’m pleased to report that the anecdotal experience, as well as available data, suggests assessments conducted with patients with schizophrenia via video can be done reliably and can be done in a way that produces valid data.”
It can be done—the tools exist. But it’s the way sponsors and CROs approach remote assessments that can make or break data integrity—and he delves into that topic in this podcast. In particular, he shares how sponsors and CROs can leverage remote assessments in their next clinical trial.
Mark Opler, PhD, MPH, is Chief Research Officer at WCG MedAvante-ProPhase. Dr. Opler was the founder of ProPhase and served as its CEO and Chief Scientific Officer, among other roles. He serves as adjunct assistant professor of psychiatry at New York University and assistant professor of clinical neuroscience at Columbia University’s College of Physicians and Surgeons. He is also leading the development of the forthcoming edition of the PANSS Manual.
Lisa Deck was a healthy 21-year old a week away from college graduation when her first stroke put her in the hospital. She barely made it to her graduation ceremony. She suffered two more strokes before she turned 25, and after that, a fourth stroke.
After serious misdiagnosis and incorrect treatments, she was finally diagnosed with Moyamoya disease, a rare condition without a cure, but it does have a surgical treatment.
In this podcast, she shares her diagnostic odyssey, her commitment to advocacy and the value of peer and family support. She also talks about the importance of staying positive and why patients must advocate for themselves.
How can CROs and sponsors detect potential problems and issues in clinical trial conduct and data quality? That’s one of the critical issues discussed in Steve Young’s interview with Linda Sullivan, MBA, Executive Director of WCG’s Metric Champion Consortium (MCC). Young, Chief Scientific Officer at CluePoint, discusses how risk-based quality management (RBQM) methodology, data analytics, and data surveillance are being utilized today to go beyond just ferreting out fraud. Now, Young says, clinical trial stakeholders are deploying advanced statistical engines to detect quality and data breaches in investigational studies. According to Young, while there are still instances, to varying degrees, of major misconduct in clinical trials, CROs and sponsors are increasingly turning to online solutions to risk planning. It’s important, he adds, that when risks are discovered, the solutions are integrated into the workflow of clinical trials. In fact, Young asserts, one of the biggest challenges facing the industry today is to embrace change and accept the use of centralized monitoring data to aid in the discovery and resolution of risk.
Interested in attending the MCC Clinical Trial Risk and Performance Management vSummit Sept. 8-10? Visit https://www.centerwatch.com/mcc-summit-2020.If you subscribe to this podcast, you can use the code POD15 to receive 15% off your registration fee.
For many of the same reasons underrepresented populations lack access to appropriate healthcare services, they are also left out of clinical trials. The problem is widely known, but solutions have been hard to come by. In this episode, Michael Poku, MD, MBA, biopharma medical director at Signify Health, explains why this is the case and then shares some approaches he and his colleagues have successfully used to remove the barriers to clinical trial participation.
An important aspect is understanding the larger picture—that inequality is due to in large measure to longstanding and systemic issues. He discusses how unmet social needs rarely occur in isolation. Addressing those needs together can lead to better representation in clinical trials.
“Sponsors are incredibly excited about opportunities to make their trials more representative and to have underrepresented minorities participate,” he says.
In addition to his work at Signify Health, Dr. Poku is on clinical faculty at Methodist Dallas Medical Center and the University of Texas Southwestern Medical Center, where he cares for patients as an internist and teaches trainees and medical students. Prior to his role at Signify Health, Dr Poku was a consultant at McKinsey & Company.
Dana Deighton, an esophageal cancer survivor, shares her diagnostic odyssey of false starts and life-threatening detours.
Deighton had always been healthy—she didn’t smoke, didn’t drink and exercised every day. Then came a joint pain that wouldn’t go away, visits to numerous doctors, a series of misdiagnoses, invasive tests, and growing symptoms. The correct diagnosis of stage 4 esophageal cancer “was not the diagnosis anyone wants.” But she refused to accept physicians’ recommendations for palliative care as a solution.
She describes her persistent advocacy to convince doctors to consider her as an individual different from expectations and generalizations. She asked the hard questions and had the hard discussions, resulting in an outcome better than expected.
She recommends physicians and patients do the homework, energetically collaborate and consider the individual patient in the quest for a solution. “Don’t be a passive patient.”
Dana Deighton works for the online patient community provider Inspire.com that helps connect patients with others experiencing the same disease, for a wide variety of diseases and over 4 million members. She also serves as an Executive Board Member of the Esophageal Cancer Action Network (ECAN), is a patient representative on the Locally Advanced Esophageal Cancer Guideline Panel for the American Society of Clinical Oncology (ASCO), a member of NCI Patient Advocate Steering Committee and NCI Esophago-Gastric Task Force and serves on the Esophageal and Stomach Cancer Project Patient Advisory Committee, a project led by the Broad Institute of MIT and Harvard. She lives outside of Alexandria with her husband and three teenagers.
Can patients be trained to report their symptoms more accurately?That’s one of the key topics discussed in Nat Katz’s and Art Morales’ interview with Linda Sullivan, MBA, Executive Director of WCG’s Metric Champion Consortium (MCC). Katz, the Chief Science Officer of WCG-Analgesic Solutions and Morales, Vice President, Technology Solutions at WCG, assert that, with proper design and implementation, you can structure clinical trials, such as pain management studies, so that patients learn how to better report their symptoms. With proper training, patients learn to accurately report their symptoms, resulting in more reliable data, according to Katz and Morales. During COVID-19, they add, sponsors have had the opportunity to examine ways to introduce new technologies, such as telehealth, to clinical trial operations and to use more science-based tools for evaluating the performance of clinical trials. COVID-19 also has accelerated the scientific evaluation of clinical sites by optimizing the analysis of patient data. The result: Clearer and more reliable data collected during the conduct of study — without unblinding the data.
Interested in attending the MCC Clinical Trial Risk and Performance Management vSummit Sept. 8-10? Visit https://www.centerwatch.com/mcc-summit-2020. If you subscribe to this podcast, you can use the code POD15 to receive 15% off your registration fee.
How are clinical trial companies pivoting to implement Risk-Based Quality Management programs during the pandemic?That’s one of the deep dives explored in Duncan Hall’s and Rachel Oakley’s interview with Linda Sullivan, MBA, Executive Director of WCG’s Metric Champion Consortium (MCC). Hall, founder and CEO of Triumph Research Intelligence (TRI) and Oakley, Vice President of RBQM Services at TRI, note that, when the COVID-19 pandemic first hit, CROs and sites performed risk assessments on their existing studies. Then those organizations took advantage of innovative technology that had a key tool for optimizing clinical trials — centralized monitoring. According to Hall and Oakley, that tool enables critical oversight and monitoring of investigational sites, even when in-person visits are not feasible. They point out that regulatory agencies are issuing new guidance during the pandemic, and that sponsors, CROs, and sites need to figure out how to comply with both those new mandates as well as existing rules. According to Hall and Oakley, there has been a renewed sense of community in the industry in dealing with the pandemic as stakeholders try to stay current through a variety of trusted sources, including MCC’s weekly COVID calls. Finally, they note, one component for optimizing clinical trials is taking center stage — training, especially in the area of RBQM.
Interested in attending the MCC Clinical Trial Risk and Performance Management vSummit Sept. 8-10? Visit https://www.centerwatch.com/mcc-summit-2020.
If you subscribe to this podcast, you can use the code POD15 to receive 15% off your registration fee.
What’s the secret to success forimplementing a world-class holistic approach to a Risk-Based Quality Management (RBQM) system? That’s one of the key topics from Artem Andrianov‘s and Johanna Proeve’s interview with Executive Director of WCG’s Metric Champion Consortium (MCC), Linda Sullivan, MBA. Andrianov, CEO, and Proeve, Chief Science Officer at Cyntegrity emphasize the importance of developing a clinical trial platform that enables your organization to manage the entire quality management cycle rather than continuing with traditional silo-based approaches. This comprehensive approach, they explain, enables pharmaceutical companies to become more efficient in reducing risk, which is especially important during the current pandemic. In addition, they note, in the COVID-19 era, more organizations have had to turn to holistic risk-based quality management systems because, for example, Excel doesn’t always work for managing RBQM, especially in larger clinical trials. Today, both CROs and sponsors are implementing innovative RBQM technology and asking for additional training to deal with data quality deterioration and other issues brought about by the onslaught of the pandemic, according to Andrianov and Proeve. Listen to this episode to find out how COVID-19 has magnified festering clinical trial shortcomings and why it’s essential that pharmaceutical company leaders become “data scientists.”
Interested in attending the MCC Clinical Trial Risk and Performance Management vSummit Sept. 8-10? Visit https://www.centerwatch.com/mcc-summit-2020.
Ever since elementary school, Gregory L. Hall, MD, knew he would be a doctor. In this interview, he shares that journey and how he came to write the book—literally—on health disparities for African Americans.
His focus on disparities began more than 30 years ago with his appointment to the Ohio Commission on Minority Health—the first such commission in the country. Eventually, when he became the chairman, he had to give quarterly reports. The research he conducted on disparities for those reports opened his eyes, he says.
“I naively believed that providers and physicians didn’t contribute to health disparities. I thought it was just poverty and a lack of insurance. I didn’t know that, actually, providers contribute to it, health systems contribute to it.” He was shocked, and what he learned led to him write his book, Patient-Centered Clinical Care for African Americans: A Concise, Evidence-Based Guide to Important Differences and Better Outcomes. It is for physicians and clinicians and is a guide outlining specific differences in communication, clinical therapies, medications, protocols and other critical approaches to the care of African Americans.
The book discusses a wide range of disorders that affect African Americans It includes clinical pearls, but it also provides the background clinicians need to understand just what drives disparities.
Providers don’t want to exacerbate disparities, but they are often unaware. If you don’t know what you’re doing wrong, you can’t fix it, he says. He is helping with both.
Even when providers do a better job addressing the specific needs of African-American patients, hurdles remain, he says. For example, lack of trust remains a huge issue among African-American patients; the shadow of historic discrimination in medical settings looms large. Almost half of African Americans report low trust of healthcare providers—and what’s interesting, he notes, is that this distrust extends to providers of all races. As a result, African Americans often don’t seek out the care they need, and they are wary of clinical trials.
In addition to being a practicing primary care physician in Cleveland, Dr. Hall has a dual appointment on the teaching faculty at Northeast Ohio Medical University College of Medicine as associate professor of both internal medicine and integrative medical sciences. He also has an assistant clinical professor appointment at the Case Western Reserve University School of Medicine.
"What impact does a remote clinical team operating model have on clinical trial performance?" That’s one of the hot topics from Ken Getz’s interview with Executive Director of WCG’s Metric Champion Consortium (MCC), Linda Sullivan, MBA. He describes several projects that the Tufts Center for the Study of Drug Development (Tufts CSDD) is currently working on; ones that will provide robust, data-driven analysis and strategic insights that help drug development professionals improve pharmaceutical R&D. Getz is the Deputy Director of Tufts CSDD and Professor at the Tufts University School of Medicine.
At any given time, Getz states that Tufts is conducting between 12 and 15 grant-funded projects. The ideas for their studies are often generated from conversations in working groups, like MCC’s member networks. They also arise from thought-provoking conversations at industry conferences. But no matter where the studies come from, the studies always provide a “think tank for that very high-level, macro-level view of what’s happening in drug development,” Getz explains.
Listen to this podcast to learn how Tufts – and the data it publishes – offers insights for organizations to transform clinical trials. “Everyone I speak with tells me they’ve tried to measure and benchmark. There are lots of internal forces that have tried to tackle benchmarking, so we’re excited to have an evidence-based approach that provides an opportunity to help organizations shape their practices moving forward.”
Interested in attending the MCC Clinical Trial Risk and Performance Management vSummit September 8-10? Visit https://www.centerwatch.com/mcc-summit-2020.
If you subscribe to this podcast, you can use the code POD15 to receive 15% off your registration fee.
Pharmaceutical executive Peter A. DiBiaso, MHA, a triathlete who has successfully completed the grueling Ironman, learned at age 49 he had early-onset Parkinson’s disease. He shares his experiences—and triumphs—in this episode.
What started as a small tremor in his right hand and a stiffness in his right ankle ended up changing his life.
It was a blow, but he knew what to do: The diagnosis brought his personal and professional life full circle. Five years later, he reports minimal disease progression. He is doing well and remains incredibly active. Other than well-managed medication, to what does he attribute his success so far?
- Staying fit and continuing to be an athlete. He is still running marathons and recently scaled Mount Kilimanjaro, the highest mountain in Africa.
- Engaging with patient advocacy groups—in particular, the Michael J. Fox Foundation. (In fact, his Kilimanjaro trek was part of a Team Fox effort to raise money for the foundation.)
- His ability to navigate the system.
He has also been involved in six clinical trials—both interventional and observational. He knew the value as an industry insider. Now, he appreciates the value from the patient perspective—and he better understands the frustrations patients face. It too often falls on the patients to initiate discussions about clinical trials. That’s fine for him, he says, but what about those who don’t know trials are available?
His professional life has focused on patient recruitment issues, so he brings a 360-degree perspective. Sponsors, he says, need to focus on more than the academic and clinical elements; they must address real-world issues and trial participants’ challenges—even those that seem minor, like parking.
It comes down to patient-centricity, he explains—putting patients at the center of the clinical research enterprise. It is becoming more common, but there’s still a long way to go.
Peter DiBiaso, MHA, is a consultant to drug development companies and has worked at Pfizer, Shire, Vertex, and IQVIA. He is married and has two children, and he and his family split their time between Paris and Boston.
Lisa Carlton, PhD, understands rare childhood diseases both professionally and personally. She was already a scientist specializing in rare diseases when her daughter was diagnosed with one: tuberous sclerosis. As VP of Global Regulatory Affairs for a biotech drug developer she is involved in development of treatments for other rare diseases too. This makes her an ideal person to co-chair an industry-patient-advocacy group called the Working Group on Regulatory Science, a part of the EveryLife Foundation for Rare Disorders that seeks to advance the development of treatment and diagnostic opportunities for rare disease patients through science-driven public policy.
Tuberous sclerosis, a rare genetic disorder, affects one in every 6,000 newborns in the United States. It is a disorder that causes benign growth in almost any tissue; it’s of particular concern when it occurs in the brain, lungs or kidneys. Some people who have tuberous sclerosis may have learning problems or difficult-to-control seizures. Her daughter—one of a pair of twins—was diagnosed in utero. She’s doing well, although the speech and language disorders associated with the condition have made it hard to access the curriculum in school.
Dr. Carlton talks about the challenges of developing new treatments for rare diseases and the approaches taken to try to overcome them. She also talks about her daughter’s disease, and how families can bring their best to their journey as they adapt to support their child. Based on her experience as a parent and advocate—as well as her experience in the industry—she has this advice for families: “Take a breath.” Drug development is slow, especially in rare diseases. “You are in for a marathon of supporting your child.”
When possible, connect with other parents and advocacy groups. Or build your own tribe—work, friends, family, etc. “You have to be healthy and rested enough to do this. You have to be at your best.”
She’s often asked how she manages to keep going. “I don’t know how I wouldn’t do it. You’ve been given this gift of a special child. Now it’s time to find your tribe and push ahead.”
Her advice for a biotech company considering launch of a clinical trial for a rare disease? Nobody knows more about a patient’s journey, the patient’s experience, than the patient—or a parent or caregiver. “Just listen to what patients are saying. You are going to learn a lot.”
Lisa Carlton, PhD, has previously worked in regulatory roles at the National Institutes of Health, Otsuka Pharmaceuticals and International Partnership for Microbicides. She is currently serving as Vice President of Global Regulatory Affairs at REGENXBIO, a gene therapy-focused biotech company with headquarters in Rockville, MD. Lisa received her PhD in Pharmaceutics and MS in Medicinal Chemistry from the University of North Carolina in Chapel Hill and a BS in Biochemistry from North Carolina State University.
In this episode, host Linda Sullivan, MBA, Executive Director of WCG's Metric Champion Consortium (MCC) chats with Laurie Halloran, founder of the Halloran Consulting Group, about how she developed an on-demand drug development team that can fill in gaps in the clinical trial process for life science companies, whether these involve regulatory strategy or execution, or quality, clinical, or manufacturing issues. The COVID-19 pandemic has resulted in these companies having to pivot to more virtual experiences. At the beginning of the outbreak, she notes, her group organized town halls that made it clear to stakeholders that life science companies had to implement telehealth and other remote monitoring solutions to protect patient safety. As a result of the pandemic, Halloran explains, her group is reviewing clinical trial protocols to determine how technology can be better utilized in the collection of clinical trial data. In conclusion, Halloran says, “don’t waste this opportunity” to make your clinical trial program more resilient.
Interested in attending the MCC Clinical Trial Risk and Performance Management vSummit September 8-10? Visit https://www.centerwatch.com/mcc-summit-2020.
If you subscribe to this podcast, you can use the code POD15 to receive 15% off your registration fee.
To fully engage Chicago’s medically underserved Chinese and other Asian communities and to help them address their own health issues, Dr. Hong Liu’s Midwest Asian Health Association reaches out in Mandarin, Cantonese and other languages—and does so in culturally appropriate ways.
The result is better access to healthcare for many low-income, often new-immigrant minorities who experience certain health problems in higher prevalence than the general population including hepatitis, liver cancer, diabetes, hypertension, heart disease and mental illness.
She and her team engage people to participate in education, screening and diagnostic services, and counseling. They also partner with hospitals, medical professionals, medical schools and drug companies to connect community members with care. Too often, she says, many don’t know what’s available, and for cultural reasons they don’t access the systems that are available to them. In many cases, the emergency department is their first stop for healthcare, and their diseases are too advanced by the time they seek it.
She talked about how her community has faced increased discrimination and harassment due to misinformation about COVID. She gives a more accurate look into the community’s nature as she describes how Chicago’s Asian-American community raised money, then used it to provide personal protective equipment to hospitals and clinics all over the Chicagoland area. Members of the community felt strongly that they wanted to demonstrate their pride and gratitude to be a part of the United States. The management of many of the hospitals sent letters of thanks, letting them know their gesture was most welcome and appreciated.
Dr Liu’s work has earned the respect of healthcare providers, the Asian-American community, and local, state and federal health agencies. In 2016 she was invited to the White House by President Barack Obama in recognition of her work.
Dr. Liu has a PhD in Public Policy Analysis from the University of Illinois in Chicago.
In this episode, Roslyn Daniels, the founder and president of Black Health Matters, talks about how her organization educates and motivates African-American communities about taking care of one’s own health.
Seeing her own grandparents die too soon and recognizing that, in many communities, people are forced to choose between rent and healthcare, she realized that “access means nothing unless you have an understanding of the fundamentals of good health.”
Using her background in media and direct-to-consumer marketing, Daniels established Black Health Matters. Its online presence and social media activity generate excitement in the public, presenting easy-to-digest information in a positive, upbeat way that appeals to a wide range of ages and interests. Its live events feature a stellar lineup of leading healthcare experts.
The 4th Annual Black Health Matters Summit will be hosted online July 18, 2020. The public can access this event free by checking out www.blackhealthmatters.com on July 18 and after that date as well. It will feature videos, resources and a lineup of featured speakers, including Michelle Obama.
In addition to her role with Black Health Matters, Daniels consults with the pharmaceutical industry. She has an extensive background in media and marketing, including director of business development for BET Networks. She also spearheaded the launch of Fitness magazine. She is a graduate of Boston University.
Our guest this episode, patient advocate Dorelia Rivera, improves access to healthcare services and clinical trials for the underrepresented, including her own Hispanic community. Her advocacy ranges from community volunteer work, to jobs for a state health and human services department, a payor, and a rare disease drug company. She advocates on Capitol Hill and served on the National Institutes of Health Advisory Council on Diversity
She’s also a mother of a child with a rare disease. Rivera’s daughter has an ultra-rare condition, NOMID--neonatal onset multisystem inflammatory disease. When she was first diagnosed, the doctor said she wouldn’t live to be 10 years old. Today, she is thriving teenager, thanks to an NIH clinical trial and her mother’s persistence.
Rivera talks about her daughter and her advocacy for underserved communities. Like those with rare diseases, racial and ethnic minorities are too often overlooked.
“Health disparities are real,” she says. The COVID-19 pandemic and the current protests are driving that home, she adds. “It’s painfully, painfully, painfully evident.” Changes need to be made concurrently across several areas, including insurance coverage, access to care, access to clinical trials, and a greater focus on the social determinants of health. “Healthcare should be a right, not a privilege.”
In terms of clinical trials, sponsors need to understand the barriers many patients--especially those in minority communities--face. Someone who needs to leave work to participate in a trial may not have a job when they return. Too often, trial sponsors aren’t flexible in addressing the obstacles potential participants face. If sponsors want to improve diversity, they need to level the playing field. “They have to meet the families where they are.”
“Our research population should match our community population.” That’s one of the takeaways from Christopher Gantz’s interview with WCG President of Patient Advocacy Steve Smith. He describes several programs that help connect researchers with minority communities to increase engagement and access enrollment in clinical trials. Gantz is senior director of the Regional Liaison Office at the Sidney Kimmel Cancer Center (SKCC) at Thomas Jefferson Hospital in Philadelphia.
Since 2005, he has worked on multiple clinical trials projects with recruitment goals ranging from 500 to 10,000 participants. He describes establishing an “honest broker network” and engagement of resources within the hospital and within the community to ease communication, build trust and facilitate trial enrollment. He also discusses some of SKCC’s language and cultural resources as well as its outreach into area schools.
Listen to learn how SKCC’s success offers a model for other organizations to transform clinical trials. “We have so many resources and so many opportunities to engage with people. I think if we're smart about it and really thoughtful in how we do it and create these longstanding relationships, it really will create a change.”
In this episode, we learn about CISCRP’s AWARE for All campaign, which builds awareness of, creates access to and encourages participation in clinical trials. Ellyn Getz, Associate Director of Development and Community Engagement at CISCRP, The Center for Information and Study on Clinical Research Participation, discusses AWARE for All.
CISCRP's flagship grassroots campaign works with diverse communities around the world to build a greater awareness and understanding of the clinical research process and the role that participation plays in advancing public health. This program is a response to health disparities in these communities—disparities rooted in the long-standing lack of access to healthcare, and gaps in understanding between these communities and the healthcare system.
Each AWARE for All event brings together a diverse array of stakeholders, including community groups, local researchers, patient advocates and community members. “Hearing from local study volunteers and local researchers is one of the most uplifting parts of this program, especially if [attendees] can hear about breakthroughs or really exciting developments and advancements in research that are taking place in their own community,” she reports.
Weeks of planning with community leaders culminates in a free community health event. Although usually done onsite and in person, the next event, on July 16, will be virtual. This will allow people to watch it live or access the information later. In addition to presentations, it will include a virtual exhibit fair with community health assessments. Details are available here: awareforall.org.
Independent expert committees provide essential validation of clinical data. Without their insights, sponsors risk missed signals, conflicts of interest and costly delays. But establishing a successful expert committee can be tricky. It requires the right combination of people, process and technology. In this three-part podcast, Lakshmi Sundar, head of business transformation at WCG ACI Clinical, explores each of these with a WCG ACI expert.
In the first part of the series, Bill Stedman, manager of member services, shares his perspective on the “people” aspect. He discusses how success rests on having the right combination of expertise. Then, Dr. Bindi Shah, chief medical officer, explains how proper processes are critical to setting and running up expert committees. In the final part of the series, Mandy Moran, manager, innovation and technology, discusses how, when deployed correctly, technology supports the people and the process, allowing committee members do what they do best and do it efficiently.
In this episode, Dolly Niles, executive director of QUEST Research Institute, talks about the role of small research sites and the value of community outreach. QUEST, a multi-specialty independent research site in metro Detroit, has conducted more than 350 phase 1-4 trials since it was established in 1996.
Niles talks about the role of agile smaller sites during the height of the COVID-19 pandemic. Many health systems and academic medical centers reassigned research staff to patient floors. Smaller sites like QUEST Research Institute have been able to step up, contract quickly and stand up new studies while completing current ones.
She also touches on the importance of connecting with the local community--including minority communities. The fact that COVID-19 is hitting minority populations particularly hard “highlights something we already know--that minority communities are underrepresented in clinical research,” she says. “Sites need to spend time figuring out how to crack that nut.”
The issue goes far beyond recruitment, she says. It requires educating patients and physicians about clinical trials. It involves establishing a trust relationship so when it’s time to recruit, potential participants have that relationship and want to know more. “We need to figure out how to make time for that.”
In this episode, Brian Loew, founder and CEO of online patient portal Inspire, talks about the value to patients and caregivers of providing a safe and trustworthy online social network--a “peaceable kingdom,” as he calls it.
Millions of patients representing 3,500 diseases--including many rare ones --come to Inspire.com for online community discussions focused on their own particular disease. The platform provides a place for meaningful conversations among patients and caregivers. It also allows them to share their insights in ways that advance clinical research. Patients want to support research, sometimes even initiating it themselves. And, more than ever, Loew says, researchers are interested in patient-reported information. If patients agree, they can also be connected to relevant clinical trials.
Loew emphasizes that across all the conditions and forums, patients always have control over what data they share and where they share it--and in his experience, the more control they have, the more willing they are to share it.
The recently added coronavirus section (www.inspire.com/coronavirus) also features video testimonials from patients with a variety of conditions describing why COVID-19 is disrupting their medical routines and threatening their health.
Loew is a frequent speaker and writer on the topics of health-focused social networks and digital health. He sits on the boards of the Robert Packard Center for ALS Research at Johns Hopkins, and New Jersey Goals of Care. He was a “Red Jacket” recipient from PharmaVOICE magazine for his contributions to the industry.
Drug policy has transformed to bring transformative improvement to the way rare diseases are developed resulting in more FDA approved treatments.
This transformation came about because of collaboration across stakeholders: patient advocates, the FDA, Congress, drug developers, researchers, and legal specialists. Profound change came in the mid 1980’s when AIDS activists, Rare Disease Activists, and others found ways to use policy to accelerate development of FDA approved treatments.
Legal specialists Frank Sasinowski of Hymen Phelps and McNamara has always been a champion of the patient voice in legislative change, drug development policy, and FDA approvals.
In this WCG Patient Radio episode with WCG’s President of Patient Advocacy, Steve Smith, Mr. Sasinowski speaks of the transition from a time in the late 90s when patients were not even considered in drug policy. He speaks of formalization of the patient voice into legislation, the Rare Disease Congressional Caucus, Patient-Centric Drug Development program at the FDA, and numerous other transformative mechanisms. Change is evident as we now see many patient-focused roles within drug development companies, working with more sophisticated patient advocacy groups, and regulators.
During this 20 minute podcast, Mr. Sasinowski also discusses the balance between the need for speed of drug development, with safety, and the concept of “certainty.” How can we include, in the drug approval process, the concept of “risk vs. benefit” as seen by patients that are in need of a therapy very soon who are willing to take more risk.
In this episode, Brian Loew, founder and CEO of online patient portal Inspire, talks about the value to patients and caregivers of providing a safe and trustworthy online social network: a “peaceable kingdom,” as he calls it.
Millions of patients representing 3,500 diseases—including many rare ones—come to Inspire.com for online community discussions focused on their own particular disease. The platform provides a place for meaningful conversations among patients and caregivers. It also allows them to share their insights in ways that advance clinical research. Patients want to support research, sometimes even initiating it themselves. And, more than ever, Loew says, researchers are interested in patient-reported information. If patients agree, they can also be connected to relevant clinical trials.
Loew emphasizes that across all the conditions and forums, patients always have control over what data they share and where they share it—and in his experience, the more control they have, the more willing they are to share it.
The recently added coronavirus section (Inspire.com/coronavirus) also features video testimonials from patients with a variety of conditions describing why COVID-19 is disrupting their medical routines and threatening their health.
Loew is a frequent speaker and writer on the topics of health-focused social networks and digital health. He sits on the boards of the Robert Packard Center for ALS Research at Johns Hopkins, and New Jersey Goals of Care. He was a “Red Jacket” recipient from PharmaVOICE magazine for his contributions to the industry.
In this podcast, Thomas Farrington, founder of the Prostate Health Network, speaks with WCG President of Patient Advocacy Steve Smith.
Mr. Farrington discusses his experience with the healthcare system, coupled with his own research on prostate cancer, which led him to become a vocal advocate for prostate cancer patients and survivors. His advocacy spans a wide range of approaches from educational seminars, a frequently-visited website, a theater production called Daddy’s Boy that is now on tour, and visits to legislators on Capitol Hill to help shape public policy for the benefit of people with this unmet medical need.
Mr. Farrington also serves as a trustee of the Dana Farber Cancer Institute and as an advisor to a number of other healthcare organizations and programs, and he is on the National Comprehensive Cancer Network’s prostate cancer treatment guidelines panel and their prostate cancer early-detection guidelines panel.
In this episode, former Assistant FDA Commissioner Jonca Bull, MD, discussesracial disparities in healthcare, how COVID-19 has made them impossible to ignore, and how this highlights the need for diversity in clinical trials.
Low-income minority communities are being hit disproportionately hard by COVID-19. Dr. Bull isn’t surprised: The current crisis has simply magnified existing disparities. A multitude of factors are at play, including lack of access to healthcare and healthful food. As a result of these and other issues, certain underlying health conditions are more prevalent in low-income minority communities.
Clinical trials must include these populations so we can truly understand COVID-19 and how to treat it in real-world conditions.
In fact, the FDA has long had guidance on how to make trials more diverse:
- Collection of Race and Ethnicity Data in Clinical Trials—Guidance for Industry and Food and Drug Administration Staff
- Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs: Guidance for Industry
She emphasizes that African Americans are willing--sometimes more willing than others--to participate in clinical trials. But they must be invited, and trials must be designed with consideration of the obstacles they face because of where they live and how they work.
Dr. Bull serves as a consultant focused on drug development and regulatory considerations; she helps guide the strategic development and implementation of clinical trial protocols. She has served in various roles, including as assistant commissioner at FDA with a focus on diverse populations and clinical trials.
This episode takes on a topic from recent headlines--namely, the racial disparity in COVID-19 cases and deaths. Edith P. Mitchell, MD, MACP, FCPP, shares her insights on the causes of these health disparities and how they relate to the coronavirus. Contributing factors include less access to testing, lack of insurance and paid time off, underlying health conditions, and the spread of misinformation about the virus.
She also touches on how racial disparities affect clinical research. “When I came to Philadelphia, we had only 7.8% participation by African Americans in clinical trials. Yet 45% of Philadelphia is African American. We have been able to raise the participation in clinical trials to a high of 24.9%, and maintain a range around 20%,” she tells WCG President of Patient Advocacy Steve Smith. “Never assume African Americans don’t want to participate in clinical trials. They must be invited, and there must be cultural competence among healthcare providers.”
Dr. Mitchell is clinical professor of medicine and medical oncology, Department of Medical Oncology; director, Center to Eliminate Cancer Disparities; and associate director, Diversity Affairs, at Sidney Kimmel Cancer Center at Thomas Jefferson University in Philadelphia. She is also a retired U.S. Air Force Brigadier General.
In this COVID-19 focused episode, Dr. David Fajgenbaum chats with President of WCG Patient Advocacy, Steve Smith, to talk about his journey as a medical researcher and patient of a rare disease and about the pandemic facing our daily lives. Known for his best-selling book, Chasing My Cure: Turning Hope Into Action, Dr. Fajgenbaum shares best practices for how everyone facing this crisis can get through these scary and trying times together as a community via hope, prayer, action, humor, and the ability to create silver linings.
Their discussion also highlights the importance of social distancing for patients with a compromised immune system during COVID-19, the fast-paced nature of research at Dr. Fajgenbaum’s institute, and the advantages of drug repurposing.
For more information on drug repurposing Dr. Fajgenbaum and his team are leading, please visit https://cdcn.org/drug-repurposing/.
In this episode, WCG’s President of Patient Advocacy, Steve Smith, talks with Dr. Charlotte Owens, MD, FACOG, Medical Director at AbbVie Pharmaceuticals, who works in the general medicine therapeutic area with a focus on women’s health. As a physician, Dr. Owens describes her passion for pursuing a career that’s truly helpful for others and her desire to educate women on how to bring healthy children into the world. As her career grew into the clinical trials industry, Dr. Owens shares how this passion for helping others grew simultaneously, especially as she saw how bringing new drugs and therapies to market is so impactful in taking care of patients all over the world.
In this episode, WCG’s President of Patient Advocacy, Steve Smith, interviews Dr. Jonathan Seltzer, MD, Chief Scientific Officer at WCG, expert on data safety monitoring boards, biomarkers, biostatistics, and clinical endpoints. During their conversation, Steve and Dr. Seltzer discuss how biomarkers are appropriate for the use of trials, especially when clinical data is tough to get. Part of this discussion turns to Duchenne’s Muscular Dystrophy (an inherited rare muscular disease) on how Patient Advocacy Groups are working with the FDA to define risk vs. benefit, and how promising a biomarker for this condition - as well as many other rare disorders - would be.
In this episode, Dr. Janet Wittes, Founder and President of WCG Statistics Collaborative sits down with WCG’s President of Patient Advocacy, Steve Smith. Their conversation focuses on the importance of reliability and efficiency in clinical trials, and how biostatisticians work closely with clinicians and patients to help ensure clear results from trials. Moreover, they dive into how biomarkers can serve as surrogate endpoints for a trial, especially in the case of rare disease studies.
In this episode, Steve Smith, WCG President of Patient Advocacy sits down with Julia Jenkins of the EveryLife Foundation to discuss the impact her organization has on giving patients a voice to legislators on Capitol Hill. Julia shares how patient communities can advocate for public policy changes, improve the FDA-regulatory approval process, and educate on the effectiveness of different trial designs for rare disease drug development. Through their conversation, Steve and Julia underscore the importance of collaboration between all clinical trial stakeholders to improve the study process.
In this episode, WCG’s President of Patient Advocacy, Steve Smith, interviews Dr. Jeffrey Cooper, MD, MMM, Vice President of Process & Strategic Improvement at WCG, expert in the conduct of clinical trials, and Parkinson’s patient himself. During their conversation, Steve and Dr. Cooper highlight the strides clinical research has made for many therapeutic areas and the promise research has for individuals across the globe. With a specific focus on Parkinson’s disease, Dr. Cooper dives into his journey as a clinical trial participant and shares his experience on finding a trial, getting enrolled into the study, and his time spent throughout the trial.
In this episode, WCG’s President of Patient Advocacy, Steve Smith, sits down with Sarah Zentack, a Certified Genetic Counselor at InformedDNA and Leslie Urdaneta, Family Support Coordinator at the National MPS Society. Their discussion highlights the importance of genetic counseling and the intelligence patients can gain to better understand their treatment options, ensure they’re receiving the correct information and interpretation of results, and feel empowered to make the right choices for their care options.
In this episode, Karmen Trzupek, MS, CGC, Director of Ocular & Rare Disease Genetic Services and Clinical Trial Services at InformedDNA sits down with WCG’s President of Patient Advocacy, Steve Smith. During their conversation, Karmen and Steve talk about the criticality of incorporating genetic counselors into the medical management of a patient’s genetic diagnosis.
In this episode, Mark Opler, PhD, MPH, Chief Research Officer at WCG MedAvante-ProPhase sits down with Steve Smith, WCG’s President of Patient Advocacy to discuss the achievements in the field of CNS and rare disease clinical research. Dr. Opler and Steve highlight the unmet need of therapies available for rare disease, the importance of patient enrollment, ensuring efficacy and safety throughout a trial, and how time is of the essence in every study that is conducted.
In this episode, Kristin Smedley sits down with President of WCG Patient Advocacy, Steve Smith, to talk about the journey her two children with retinal blindness have experienced. Known as the “happiest mom of two blind kids” and a powerful TEDx talker, Kristin highlights the CRB1 rare genetic degenerative disease both of her boys are affected with. She underscores the importance of genetic diagnosis and shares the impact clinical trials and patient advocacy groups have had in finding a cure for this disease.
In this episode, Sarah Tompkins, Patient Advocate of Ehlers-Danlos Syndrome, chats with WCG’s President of Patient Advocacy, Steve Smith. During their discussion, Sarah shares with us her experience being a patient with a genetic rare disease who is involved in a clinical trial.
In this episode, Amanda Moore, CEO of Angelman Syndrome Foundation speaks with Steve Smith, WCG’s President of Patient Advocacy. As a mom whose son has been diagnosed with Angelman Syndrome - a rare neuro-genetic disorder that affects 1 in 15,000 children - Amanda walks through the time from receiving initial diagnosis to the odyssey of her son’s patient journey in therapy and clinical trials.
In this episode, WCG’s President of Patient Advocacy, Steve Smith, talks with Emil Kakkis, MD, PhD, Chief Executive Officer of Ultragenyx Pharmaceuticals and President of the non-profit EveryLife Foundation for Rare Diseases organization. Known for his work in developing an enzyme replacement therapy for the rare disorder MPS I and his connection to the Ryan Foundation, Dr. Kakkis shares with us his experiences in being involved in bringing drugs to market and forming relationships with patients along the way.
In this episode, Mark Dant, Founder of the Ryan Foundation speaks with Steve Smith, WCG’s President of Patient Advocacy. Their conversation highlights the importance of Patient Advocacy Groups – and the resources they bring to individuals diagnosed with a disease – as well as the great promise clinical trials bring to patients. Mark shares a personal story of his son, Ryan, who was diagnosed with MPS I, and how Patient Advocacy Groups and clinical trials have positively impacted their lives.
In this episode, WCG’s President of Patient Advocacy, Steve Smith, sits down for an interview with Dr. David Fajgenbaum, Assistant Professor of Medicine at the University of Pennsylvania and Author of Chasing My Cure: A Doctor’s Race to Turn Hope Into Action. In this podcast, you’ll hear Steve and Dr. Fajgenbaum discuss what it’s like to be a patient of a rare disease – in this case Castleman’s disease – and Dr. Fajgenbaum’s fight to find a cure for his own disease. This is a story of incredible courage and uniquely acquired wisdom. It is a story of triumph over adversity. And it’s a story of life changing, groundbreaking hope.
What’s the state of clinical trials in autism and neurodevelopmental disorders? What’s on the horizon?
Scott J. Hunter, PhD, a member of WCG’s Scientific Leadership Team, shared his insights during a recent conversation with Mark Opler, MD, PhD, Chief Research Officer at WCG-MedAvante-ProPhase. Dr. Hunter is a professor of psychiatry and behavioral neuroscience, as well as pediatrics, at the University of Chicago.
Despite advances in science and technology, we still see that 80% of clinical trials are running behind on their enrollment timeline.
Mark Summers, Founder of WCG ThreeWire, and President of Patient Engagement at WCG, shares his insights on the current industry model of patient recruitment and the philosophy behind the new patient recruitment paradigm.
Things you will learn in this podcast:
- Shortcomings of the current industry model of patient recruitment
- How to better plan for and deploy patient recruitment strategies
- How to find the most reliable and resource effective patients
- The economic philosophy of planning and deploying a patient recruitment program
Dr. Andrew J. Cutler shares his insights on the current challenges and opportunities for CNS therapies during an energizing conversation with Dr. Mark Opler, Chief Research Officer at WCG MedAvante-ProPhase.
Dr. Cutler is a member of WCG’s Scientific Leadership Team, and a recognized expert in CNS therapies and clinical trials. Dr. Cutler is a sought-after speaker about the evaluation and treatment of mental illnesses such as ADHD, Bipolar Disorder (Manic-Depression), Major Depression, Anxiety Disorders and Schizophrenia. He conducts clinical trials for Phase I-IV studies. Indications include ADHD in children, adolescents and adults, depression, anxiety, bipolar disorder, schizophrenia and other neuropsychiatric and medical conditions. In addition to being the Chief Medical Officer for Meridien Research, Dr. Cutler is a Courtesy Assistant Professor of Psychiatry at the University of Florida.
Dr. Seltzer, president and founder of ACI Clinical, and chief scientific officer of WCG Clinical, shared his insights on expert committees during a recent conversation with Bill Stedman, manager, member services, ACI Clinical.
Dr. Katz, Chief Science Officer and the founder of Analgesic Solutions, shared his insights during a recent conversation with Mark Opler, MD, PhD, Chief Research Officer at WCG’s MedAvante-ProPhase. WCG recently acquired Analgesic Solutions.
Christoph U. Correll, MD, a member of WCG’s Scientific Leadership Team, shared his thoughts in a recent conversation with Mark Opler, MD, PhD, chief research officer at WCG-MedAvante-ProPhase. Dr. Correll is both a clinical psychiatrist (for both adults and children) and a clinical scientist. His work focuses on the identification, characterization and treatment of adults and youths with severe psychiatric disorders. His particular area of expertise is psychopharmacology.
Leslie Citrome, MD, MPH, a member of WCG’s Scientific Leadership Team, shared his insights during a recent conversation with Mark Opler, MD, PhD, chief research officer at WCG-MedAvante-ProPhase. Dr. Citrome has a private practice and is clinical professor of psychiatry and behavioral sciences at New York Medical College in Valhalla.