Clinical Trial Podcast & Blog: Recent Episodes
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One of the little known and less discussed aspects of clinical trials is insurance.
What type of insurance, if any, is needed to conduct a clinical trial?
What does purchasing a clinical trial insurance policy entail?
How does starting a new clinical trial impact your medical product insurance policy?
To answer these questions and more, I invited Dan Fuld to the podcast.
Dan is a seasoned insurance professional with 10+ years of underwriting and broking experience.
Dan understands the needs of his clients and leverages his industry knowledge, relationships, and experience to ensure his clients obtain best in class asset protection programs. Dan and his team also assist in the implementation of alternative risk mitigation strategies, and see themselves as strategic partners to those in the life science space.
Dan graduated from the Katie School of Insurance at Illinois State University where he studied Risk Management and Finance.
Dan received his Chartered Property Casualty Underwriter (CPCU), Associate in Surplus Lines Insurance (ASLI) and Associate in Risk Management (ARM) designation in 2013 and received his property & casualty producers license in 2018.
Please enjoy my conversation with Dan Fuld!
Sponsor(s):
This podcast is brought to you by Calyx. Calyx is a trusted name in medical imaging, having delivered imaging services to meet the needs of global biopharmaceutical sponsors and clinical research organizations for over 25 years. To learn more, visit https://www.calyx.ai/
This podcast is brought to you by Veeva SiteVault. Veeva connects patients, sites, and sponsors, on a single technology ecosystem to make clinical trials easier and faster. SiteVault gives research sites one place to work with sponsors – to reduce the number of systems and logins used to run clinical trials. To learn more, visit https://sites.veeva.com/.
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To learn more about clinical trials in diabetes, I invited Dr. Stayce Beck, Global Vice President of Clinical Affairs at Dexcom Inc. on the podcast.
Dr. Beck currently oversees clinical operations, clinical strategy and science, biometrics and human factors at Dexcom Inc, a leading manufacturer of continuous glucose monitors (CGMs)
Prior to joining Dexcom, Dr. Beck worked at Food and Drug Administration for over ten years, spending time as a scientific and regulatory reviewer, a chief of the Diabetes Diagnostic Devices Branch, and Deputy Office Director of Personalized Medicine and Molecular Genetics.
Dr. Beck received her Ph.D. in Biomedical Science from the University of California San Diego, and her B.S. in Chemical Engineering from the University of Texas at Austin.
She also received her Master of Public Health (MPH) in Epidemiology from University of Maryland Baltimore.
In her free time, she enjoys spending time with her kids, reading, hiking, and running.
I hope you enjoy my conversation with Dr. Stayce Beck.
Sponsor(s):This podcast is brought to you by Calyx. Calyx is a trusted name in medical imaging, having delivered imaging services to meet the needs of global biopharmaceutical sponsors and clinical research organizations for over 25 years. To learn more, visit https://www.calyx.ai/
This podcast is brought to you by Veeva SiteVault. Veeva connects patients, sites, and sponsors, on a single technology ecosystem to make clinical trials easier and faster. SiteVault gives research sites one place to work with sponsors – to reduce the number of systems and logins used to run clinical trials. To learn more, visit https://sites.veeva.com/.
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Providing patients access to novel medical products can be challenging to navigate for sponsors and trial participants alike.
To learn more about expanded access, compassionate use, Right to Try laws, I invited Dr. Alison Bateman-House, PhD, MPH, MA, an Assistant Professor in the Division of Medical Ethics at NYU Grossman School of Medicine.
Dr. Bateman-House is co-chair of the Working Group on Compassionate Use and Preapproval Access (CUPA), an academic group that studies ethical issues concerning access to investigational medical products and which consists of patient advocates, clinicians, members of industry, current and former FDA staffers, lawyers, and academics, among others.
She advises biopharmaceutical companies, patient advocacy organizations, governmental, and non-governmental entities about clinical trial design and non-trial access programs, and she serves as ethicist for numerous data safety monitoring boards overseeing clinical trials.
She has published and spoken extensively on non-trial access to investigational medical products, equity in clinical trials, individualized therapeutics, the history and ethics of using humans as research subjects, and public health ethics.
Sponsor(s):
This podcast is brought to you by Florence Healthcare. Florence eliminates chaotic workflows in clinical research operations with remote access and digital workflow platforms. More than 12,000 study sites, sponsors, and CROs in 45 countries trust them to accelerate their operations. To learn more, visit https://florencehc.com
This podcast is brought to you by Slope. Slope drives operational excellence for highly complex, sample-intensive, early-phase clinical trials. The platform transforms chaotic clinical trial supply chains into protocol-specific operational workflows for sponsors, CROs, clinical research sites and labs. Learn more at https://www.slopeclinical.com/
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A clinical trial newsletter is a low tech tool that can help you drive site engagement. Here is 5 content ideas for your […]
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Unlike an electrical engineer or a plumber, clinical research roles are not explicitly defined or categorized as such, in government employment databases. There […]
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The FDA wants pharmaceutical and medical device manufacturers to enroll diverse patients in clinical trials. One way to achieve the diversity goal is […]
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During a dinner conversation with a colleague last week, I was reflecting on why clinical trials were so complicated. It all boils down […]
The post Why Are Clinical Trials Complicated? appeared first on Clinical Trial Podcast & Blog.
Community health system-based research continues to become an important focus area for pharmaceutical and medical device sponsors given the recent FDA guidance on diversity in clinical trials.
Our guest for this episode is JoAnne Levy, Vice President at Mercy Research, a part of Mercyhealth.
Mercy Research is one of the largest fully integrated, community health system-based research organizations in the United States with more than 40 acute care, managed, and specialty hospitals, convenient urgent care locations, imaging centers and pharmacies. In 2022, over 38,000 Mercy patients contributed to research learning.
JoAnne has served in the healthcare industry for almost 30 years. She leads Mercy Research, a not-for-profit organization managing clinical and real-world-evidence research activities across Mercy. JoAnne serves as current Chair and inaugural founder of Mercy Women in Leadership Council and as a member of Mercy’s Diversity, Equity, Inclusion and Belonging Advisory Board.
JoAnne received her undergraduate, law and master of business administration degrees — all
with honors — from Washington University in St. Louis.
Please join me in welcoming JoAnne on the Clinical Trial Podcast.
Sponsor:This podcast is brought to you by Veeva. Veeva connects patients, sites, and sponsors, on a single technology ecosystem to make clinical trials easier and faster. I’m particularly excited about Veeva SiteVault. SiteVault gives research sites one place to work with sponsors – to reduce the number of systems and logins used to run clinical trials. To learn more, visit https://sites.veeva.com/.
This podcast is brought to you by Slope. Slope drives operational excellence for highly complex, sample-intensive, early-phase clinical trials. The platform transforms chaotic clinical trial supply chains into protocol-specific operational workflows for sponsors, CROs, clinical research sites and labs. Learn more at slopeclinical.com
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In this episode, we’re going to talk about Postmarket Surveillance Studies.
In light of the EU Medical Device Regulation (MDR), medical device manufacturers are required to implement a Postmarket Surveillance (PMS) plan, which in turn may require them to conduct Postmarket Surveillance Studies.
To learn about Postmarket Surveillance Studies regulatory requirements, process for collecting clinical data for such studies, key elements of PMS plan, and more, I invited Dr. David Rutledge on the podcast.
David is the President & CEO at Global Strategic Solutions, where he works as a global consultant for clinical evaluations, clinical risk management, regulatory, quality, and clinical investigations.
David brings over 25 years of experience and knowledge in product-level analysis, clinical protocol and case report form development, scientific data analysis, organizational design, integration of science with business needs, quality management systems, signal detection, global clinical evaluations, clinical risk management, and regulatory affairs.
David is Six Sigma and CAPA certified, an ISO 13485 lead auditor, the author of Mythical Medical: Revelations from a Global Product Approval Consultant.
Enjoy!
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In this episode, we will explore the role of design in clinical trials, with a focus on electronic Patient Reported Outcome (ePROs).
Most clinical research professionals are so focused on protocol development, data collection, and analysis that it’s easy to overlook the importance of well-designed technology that supports clinical trials.
One such technology product is electronic Patient Reported Outcomes or ePROs. ePROs are surveys that are presented to and completed by clinical trial participants as part of the study requirements.
To learn more about ePROs and the role of design in clinical trials, I invited Bruce Hellman and Ben James on the Clinical Trial Podcast.
Ben is the Chief Design Officer and Co-founder at uMotif. Ben leads the product team and is responsible for the uMotif technology roadmap with the focus of bringing consumer grade technology to the life sciences industry.
Bruce is the Chief Patient Officer & Co-Founder at uMotif. Bruce is uMotif’s entrepreneurial leader and co-founded the company along with Ben in 2012.
Enjoy!
SponsorsThis podcast is brought to you by Slope. Slope drives operational excellence for highly complex, sample-intensive, early-phase clinical trials. The platform transforms chaotic clinical trial supply chains into protocol-specific operational workflows for sponsors, CROs, clinical research sites and labs. Learn more at slopeclinical.com
This podcast is brought to you by Florence Healthcare. Florence eliminates chaotic workflows in clinical research operations with remote access and digital workflow platforms. More than 10,000 study sites, sponsors, and CROs in 45 countries trust them to accelerate their operations. To learn more, visit https://florencehc.com
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In this episode, you’ll learn about the world of Clinical Trial Site Networks.
There are advantages and disadvantages when it comes to being a standalone clinical trial site.
Standalone clinical trial sites enjoy the freedom of running their own operations. But they may face challenges with executing some parts of a clinical trial.
This is where site networks come in.
For example, a site can run more efficient marketing campaigns, be more systematic in its clinical trial operations, or share patient recruitment and retention resources by being part of a site network.
To learn more about site networks, I invited Christian Burns, President of Elligo (El Eh Go) Health Research and Co-Founder of ClinX, on the show.
Christian is a serial entrepreneur, investor, and founder of multiple clinical trial companies, including ClinEdge, BTC Network, and Guidestar Research.
Christian has a track record of success in the pharmaceutical industry, with a particular focus on decentralized and direct-to-patient clinical trials.
With experience across most therapeutic areas and a presence in over 30 languages and 40 countries, Christian’s companies have served patients and providers across thousands of research sites globally.
His goal is to accelerate the development of new therapies by creating innovative solutions that connect and empower the clinical trial ecosystem.
A native of Philadelphia, Christian holds a B.A. in Public Health from the University of Tampa.
Please join me in welcoming Christian on the show.
Sponsors:This podcast is brought to you by Veeva. Veeva connects patients, sites, and sponsors, on a single technology ecosystem to make clinical trials easier and faster. I’m particularly excited about Veeva SiteVault. SiteVault gives research sites one place to work with sponsors – to reduce the number of systems and logins used to run clinical trials. To learn more, visit https://sites.veeva.com/.
This podcast is brought to you by Slope. Slope’s eClinical Supply Chain Management (eCSCM) platform reduces clinical trial risks, reigns in costs, improves the productivity of clinical trial collaborators, and increases subject retention by removing the manual, spreadsheet-driven, and error-prone processes used to manage and track clinical supplies and biological samples to a digital platform. To learn more, visit slope.io.
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In this episode, I’m excited for you to learn about Heart Failure Clinical Trials for medical devices.
Our guest today is Sonna Patel-Raman. Sonna is currently the President at NuPulse Inc, an early stage medical device company responsible for developing the first minimally invasive, long-term, ambulatory counterpulsation device that works in sync with the heart.
At NuPulse, Sonna is responsible for developing and executing on strategic initiatives for the company, building a diverse and multidisciplinary team of engineers, regulatory and quality associates, marketing, manufacturing, clinical affairs and education, and trial operations.
Sonna and her team successfully completed enrollment in an FDA-approved feasibility trial and are now working towards the next phase of their medical product development lifecycle.
Sonna has extensive experience in the heart failure medical device space.
Prior to joining NuPulse in 2015, she worked as the FDA Branch Chief where she managed a team of 16+ reviewers and clinicians and was responsible for the technical review and development of pre-marketing approvals (PMAs), Investigational Device Exemption (IDEs), 510k)s and more.
In this interview, Sonna provides us with a great introduction to heart failure trials, an overview of the medical device ecosystem for the treatment of heart failure, unique operational considerations for heart failure clinical trials, working as a woman leader in the medtech space, and more.
Sonna is an effective communicator (as you’ll soon find out after listening to this interview) and an amazing human being.
I hope you enjoy my conversation with Sonna Patel-Raman.
Sponsors:This podcast is brought to you by Veeva. Veeva connects patients, sites, and sponsors, on a single technology ecosystem to make clinical trials easier and faster. I’m particularly excited about Veeva SiteVault. SiteVault gives research sites one place to work with sponsors – to reduce the number of systems and logins used to run clinical trials. To learn more, visit https://sites.veeva.com/.
This podcast is brought to you by Slope. Slope’s eClinical Supply Chain Management (eCSCM) platform reduces clinical trial risks, reigns in costs, improves the productivity of clinical trial collaborators, and increases subject retention by removing the manual, spreadsheet-driven, and error-prone processes used to manage and track clinical supplies and biological samples to a digital platform. To learn more, visit slope.io.
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To learn more about site reads and the role of medical imaging software, I invited Kelie Williams Luby, Vice President of Clinical Trials at Mint Medical.
Kelie has 24 years of experience as a clinical trial researcher, first as a medicinal chemist, and for the past 19 years as a clinical trialist in medical imaging-based endpoints.
She is passionate about optimizing clinical trial designs while reducing the cognitive burden placed on healthcare providers treating patients in those clinical trials.
Kelie believes it is possible to improve the efficiency of how clinical trials with imaging-based endpoints are conducted while also improving the reliability of data abstracted from participants during clinical trials.
She holds a B.S and M.S in Chemistry along with a Master’s in Technical, Scientific, and Medical Communication.
Please join me in welcoming Kelie on the Clinical Trial Podcast.
Sponsor:This podcast is brought to you by Calyx. Calyx is a trusted name in medical imaging, having delivered imaging services to meet the needs of global biopharmaceutical sponsors and clinical research organizations for over 25 years. To learn more, visit https://www.calyx.ai/
We put a lot into the EDC, we put a lot into how we’re going to get data away from the site. But how much technology are we invested in helping the sites in their day to day and actually doing the work that we’re asking them to do so that we can get that data? – Kelie Williams Luby
Selected Links From The Episode:Connect with Kelie Luby Williams – LinkedIn
RECIST 1.1
WHO Criteria – Reporting Results for Cancer Treatment (1981)
Clinton-Kessler Oncology Initiative
FDA Modernization Act of 1997
NIH Protocol Template
Transcelerate Biopharma Common Protocol Template
Association of Clinical Research Professionals (ACRP) Training Catalog – iRECIST training can be found here and here.
iRECIST: guidelines for response criteria for use in trials testing immunotherapeutics
Mint Medical imaging software
Picture archiving and communication system (PACS)
Prostate Imaging Reporting & Data System (PI-RADS)
Lung CT Screening Reporting & Data System (Lung-RADS®)
Musculoskeletal Reporting and Data System (MSK-RADS)
Prostate Cancer Working Group 3 (PCWG3)
Lugano 2014 criteria for assessing FDG-PET/CT in lymphoma: an operational approach for clinical trials
Made to Stick: Why Some Ideas Survive and Others Die by Charles Kahlenberg, Chip Heath, et al.
A Seat at the Table: IT Leadership in the Age of Agility by Mark Schwartz
Show Notes: [3:42] Imaging workflow at a site in a typical oncology trial
- Site enrolls patients
- Patient undergoes protocol specific imaging scans and tumor response assessments such as a RECIST 1.1 assessment
- Patient undergoes standard of care (SOC) imaging scans and radiology routine evaluations. This information goes into a Tumor Response Form
- Both protocol and standard of care radiology assessments are shared with (a) PI/ oncologist, and (b) the trial sponsor via electronic data capture (EDC)
This information helps determine to determine whether the patient will stay on study, what the status of their disease course is, and how they carry on throughout the remainder of the trial, and they’re scheduled to them
[7:32] The standard of care and protocol requirement reads may differ
[8:08] Interpretation of the protocol requirements and response criteria can vary from site to site.
- There are a handful of response criteria which may be protocol specific, treatment specific, reiterations of prior versions, etc.
- Protocol need more specificity, more details for the end user in terms of how they’re applying a particular protocol, specification for evaluation
[12:41] Ideal working relationship between oncologist and radiologist at a site
- Information is being assessed by the radiologist and then sent to the oncologist
- Oncologist is then interpreting the structured reported information from the radiologist in order to make a decision on the patient
[14:01] History of response criteria
- Clinton-Kessler Oncology Initiative of 1996 – we can have imaging as a surrogate endpoint
- FDA Modernization Act of 1997 – we can do multiple endpoints on a clinical trial
- WHO Criteria
- RECIST 1.0
- RECIST 1.1
Now we have response criteria for different response criteria for different indications. There is response criteria for non-imaging indications or evaluations
[18:14] Site read versus central read
- Site read
- Evaluation of the patient at the site of how they’re doing on the treatment
- A way for the data to lead the site through the EDC, so it can go back to the Sponsor, and the Sponsor can then evaluate how their therapy is working
- Central read
- It’s about variability, bias, and our trust in the data
- Additional analysis that needs to be done on the imaging data that perhaps would not be appropriate or burdensome for the site to do
- Collection of all of the scans from the various clinical sites, and then doing an objective review of that imaging data
- Involves trained physician radiologists readers that are guided by an imaging charter or by a reader rules manual on how to approach the read
- Controlling the workflow in terms of sequential locked review
[21:04] Discrepancy between site read and central read i.e. site-central read discordance and how important is it?
- Depends on the endpoint of the study
- How information is collected and reported
- Indication in question
[22:05] Why do we have site-central read discordance?
- Imaging CROs have software tools that they use to do the analysis. Sites don’t always have that
- Sites may be using a paper form
- Radiology transcription and EDC data entry procedure
[22:37] Are sites that are not using imaging software at a disadvantage?
- It is beneficial for sponsors to have sites that do have imaging software that can help them and assist the radiologists and the PI in doing study evaluations
[22:39] Are site reads and central reads assessed by the same or different criteria?
- Both reads are assessed by the same criteria based on the protocol, which serves as the guiding document
- Imaging CRO develops an imaging charter that may refine the assessment – what do in corner cases? What to do in gap cases?
[25:28] “Compare to Prior” issue
- Results stable compared to prior scan versus baseline
- Benefit of response evaluations because they compare to baseline
[26:38] Training plan for a radiologist participating in clinical trial versus radiologist responsible for routine clinical care
- Training is limited/ lacking at the site level
[27:49] Should sites look at what the case report forms require them to enter and then work backwards to see if their workflow matches that?
Issue sites face:
- Sites contact the imaging CRO/ lab about about a protocol required assessment
- Imaging CRO/ lab look at the text heavy protocol together
- Imaging CRO/ lab advises the site to look at the EDC guidelines for data collection/ entry
- After trying to figure out how to get and report the data, the site and imaging CRO/ lab end up back to the protocol
Radiology imaging evaluation completed → signed off by the PI and entered in in EDC → Sponsor/ CRO generate missing data/ values query to the site → study team reaches out to the radiologist for missing data/ values → radiologist explains he/ she was never asked to collect this value as per the protocol
This increases the cognitive burden on the sites and it takes time away from treating patients.
Proposed solution:
- Everything that is needed from the data collection should be in the protocol…nothing should live outside of the protocol
- We need think about how we’re capturing the data in the end
- Consider timing of when the protocol is finalized in relation to the EDC
- Road test your case report forms – go through the process of what that looks like
[32:53] Downside of being too specific in the protocol and how it leads to protocol amendments
[33:48] Get research coordinators at 2-3 sites review and critique your protocol and case report forms
[34:38] Process to educate yourself on an imaging criteria – learn to bucket the different assessments that are being required per protocol
- What is the indication?
- What is qualitative in the evaluation?
- What is the quantitative in the evaluation?
- What are the measurements that are required to do the quantitative evaluation?
[38:09] Sponsor Message
Calyx is a trusted name in medical imaging.
Calyx’s experience includes over 2,600 clinical trials and 270 FDA supported approvals and spans multiple therapeutic areas, with significant concentration in oncology and CNS-related drug development across all phases, geographic areas, and degrees of complexity.
To learn more about how Calyx can help you with your imaging needs, visit calyx.ai or contact your Calyx solutions specialist today.
[39:47] Benefits for utilizing medical imaging software
- Time savings – the medical imaging software is assisting/ guiding you through the analysis that you’re performing
- Structured data reporting
- Maximizing the data that we can abstract from an image
- Keeping the information from imaging data intact digitally for the patient as it moves through the process – data liquidity
[42:04] Alternatives to imaging software – paper forms
[43:47] Downsides of measuring or performing tumor measurements directly in PACS
- PACS is for viewing and moving imaging information
- PACS is not intended for capturing information
[44:57] Imaging assessment process or criteria between protocols and routine care
- There are published guidelines for screening and staging evaluation
- Response criteria is a communication language. It’s a way to communicate information and structure and to make it comparable
[46:12] What is screening and staging?
- Patients are screened based on assessment tools such as PI-RADS, Lung-RADs etc.
- Patients are staged based on the status of where the disease is, how it’s confined, if it’s metastasized, if you have lymph nodes, metastatic sites etc.
- Staging is part of a cancer study protocol inclusion and exclusion eligibility criteria
- Criteria such as RECIST are intended to evaluate for structured data reporting
- There are separate guidelines for therapy evaluation
[49:41] Protocol specific evaluation criteria i.e. modified criteria
- Based on a particular drug mechanism of action
- Sponsor is looking to evaluate the particular treatment effect or otherwise
- A patient population specific modification may be necessary
- Sometimes it’s not clear in the protocol what aspect of the criteria has been modified.
- Sites don’t want to have to go to the end of the line, when they’re reporting data to figure out what they should have done at the beginning
[55:59] How to road test a clinical trial protocol before finalizing it?
- Have a research coordinate at one or more sites review and critique your draft protocol
- Do a sample case
- Does the end user have the tools at their site to report what they’re being asked to do per protocol
Good, comprehensive medical writing is the glue that holds together all the documents
[58:11] Based on the protocol, ask the sites if they have the means to do the evaluations
[59:01] Is there integration between imaging software and electronic data capture (EDC)?
- It’s possible to go from site radiology read straight into EDC. We don’t always do that and it involves manual data entry
- Importance of automation – site imaging assessment and sponsor EDC integration
[1:08:55] Sites using their own imaging software – Bring Your Own Software (BYOS)
[1:11:48] Imaging challenges when a patient is participating in multiple clinical trials
[1:12:37] Challenges when different hospitals or different technicians within the same hospital capture images
[1:13:06] Are sites still using X-Ray films or are imaging scans now digital?
[1:13:35] Interactive lesion location and machine readable imaging data
[1:15:00] Medical writing skills
- You learn how to read a protocol
- When you write things, but you don’t actually know how they work in the context of real use
- You have to try to get more information on how it’s done. Once you see it, and you understand it, then the context is linked, and that really sticks
- If there is an indication that you’ve never worked on before, you have to go and find patient and people stories. You have to understand what the actual human context is, what the patient experiences and what the provider experiences treating that particular indication. This will help tie all together with what your writing on
[1:17:23] Challenges as a medical writer
- Not understanding the context of what you’re writing about
- Not seeing what the data looks like on the other side
[1:20:56] *Sponsor Message*
Calyx has been a trusted name in medical imaging for almost two decades.
Kunal shares his own personal experience working at Perceptive Informatics (now Calyx).
To learn more about how Calyx can help you with your imaging needs, visit calyx.ai or contact your Calyx solutions specialist today.
Why We Have Missing Medical Imaging Data?The post Medical Imaging for Clinical Trial Sites with Kelie Luby appeared first on Clinical Trial Podcast & Blog.
Our guest today is Bijan Elahi, where we talk about risk management for clinical investigators conducting medical device clinical trials. In this episode, […]
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In this episode, I’m excited to share with you 5 Strategies for planning and conducting investigator and steering committee meetings. Now that the […]
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If you’re a sponsor responsible for outsourcing your clinical trials or someone who is curious about what clinical trial outsourcing entails, you’re in […]
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When a new drug or device undergoes “first in human” experience, the primary focus is on participant safety. How will the drug or […]
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Phase I trials are generally conducted in healthy participants or in patients with no treatment options such as oncology patients. Unlike late phase […]
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In this episode, I’m excited to talk about medical imaging in clinical trials. We’ll discuss the role of a medical imaging CRO, imaging […]
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Who owns the clinical trial data generated in industry sponsored or investigator initiated clinical trials? What responsibilities do Sponsors, CROs, or Sites have […]
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In the fiscal year 2021, the National Institute of Health (NIH) funded only 16,959 out of 80,878 research project grants. In other words, […]
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In this episode, we tackle another important aspect of clinical research finance, specifically, coverage analysis for US based clinical trials. At the beginning […]
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There is more to the world of clinical data management than building and cleaning databases. Did you know you can leverage your clinical […]
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A big part of managing clinical research at any site is managing clinical research billing. If you don’t keep track of your research […]
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Have you been tasked to develop a clinical trial budget? Well, you’re in luck because I’m going to share everything you need to […]
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One of the most time and resource intensive tasks in clinical research is data entry. Clinical research coordinators spend countless hours transferring clinical […]
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As the clinical research ecosystem becomes more site and patient centric, I was curious about what an ideal software stack looks like for […]
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Dr. Bierer is the Director of the Regulatory Foundations, Ethics and the Law Program of the Harvard Clinical and Translational Science Center and […]
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Top 10 Reasons for Patient Recruitment Failure in Clinical Trials This episode and post highlights the Top 10 Reasons for Patient Recruitment Failure […]
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Clinical trials are conducted in compliance with regulations. Simply stated, you need a clinical and regulatory strategy when it comes to conduct of […]
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The pandemic has helped fast track the adoption of technology in clinical research. This has been a much needed change and we’re headed […]
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My guest for this interview is Rebecca Matthews, Chief Clinical Operations Officer at Multidisciplinary Association for Psychedelic Studies (MAPS) Public Benefit Corporation.
In this interview, Rebecca shares with us what it takes to conduct clinical trials investigating the use of MDMA, a psychedelic drug, in conjunction with psychotherapy to treat patients with post traumatic stress disorder (PTSD).
PTSD can occur after a person experiences a significant trauma, like a sexual assault, severe physical assault, significant threat to life arising from a hate crime, natural disaster, war, or accident. It affects people of all races, ages, and backgrounds.
As you’ll hear from Rebecca shortly, the clinical data from the recent clinical trial looks extremely promising.
This interview will leave you with excellent insights on differences and challenges of conducting research with psychedelic drugs including site selection, patient recruitment, clinical trial design considerations and more.
I am beyond excited to discuss this important topic of psychedelic research on the podcast.
Please join me in welcoming Rebecca Matthews on the Clinical Trial Podcast. Enjoy!
Sponsor Florence Healthcare: Transform your Clinical Trials with the #1 Platform for Electronic Document Workflows and Remote Site Access.
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[3:27] There are different psychedelic drugs such as psilocybin, ketamine, ibogaine, ayahuasca. MAPS is focused on MDMA for PTSD and cannabis for treating symptoms of PTSD
Show Notes Correction: Phase II Clinical Trial Data In MAPS’ completed Phase 2 trials with 107 participants, 61% no longer qualified for PTSD after three sessions of MDMA-assisted therapy two months following treatment. At the 12-month follow-up, 68% no longer had PTSD. All participants had chronic, treatment-resistant PTSD, and had suffered from PTSD for an average of 17.8 years.
[4:38] State of Colorado and Michigan supporting clinical research in the psychedelic space
[4:54] Brief history of psychedelic drugs and what led FDA to support MDMA research via Breakthrough Therapy Designation and Special Protocol Assessment
[8:05] Current status of MAPS Benefit Corporation MDMA studies including data from phase II studies
[9:19] Why Sponsors are not too keen on securing Breakthrough Therapy designation
[11:49] Why are for-profit companies not interested in MDMA?
[13:05] Clinical trial design considerations including diversity in patient population, diversity in therapist, clinical trial sites, access to care, educators, community acceptance,and public perception
[14:14] Additional consideration for acceptance of MDMA:
- Who does it work for?
- How long does the effect work?
- How does it affect the health care system?
- How does it affect you in your life?
- How does it affect you in your life and being able to go to work or go to school?
- Will insurers want to have this on their policies?
- Will companies want to support it?
[14:54] Community acceptance of MDMA
[16:10] Follow-up schedule for MDMA therapy
[16:46] Opportunities with MDMA therapy training program
[18:30] Clinical trial facility needs to be conducive with the MDMA assisted therapy
[19:54] Site and therapist selection
[20:47] Obtaining Drug Enforcement Administration Schedule I license ( storage, paperwork, scheduling DEA inspections, drug locked in the cabinet, alarm report, unannounced inspector visits)
[23:12] Training and scholarship program
[24:58] Patient recruitment challenges and opportunities
- PTSD recruitment website with screening questions for subjects → sites
- Participants live far away from the site
- Participants do not have qualifying trauma
- Health conditions/ comorbidities
[26:25] Enrollment rate and importance of participant diversity
[27:59] How to increase enrollment?
- Staff at MAPS Public Benefit organization
- Staff at sites
- People being trained or reached out to
- Involvement at conferences
[30:07] Compassionate Use and Expanded Access Program
- Sites in different areas – expanded site access
- Train clinics
- Train therapist
[31:10] What is Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)?
[33:10] Stakeholders at the site include the study coordinator, therapist, and physicians (MDs)
[35:25] How DEA, FDA, and MAPS Public Benefit Corporation (Sponsor) work together?
[39:23] Central IRB (fast but expensive) versus local IRB (low cost/ free but slow)
[39:57] Patient centric activities (welcoming office, therapist comes ahead of time, plants/ flowers, clean, not loud, feels protected, without outside distractions)
[41:46] MAPS Public Benefit Corporation – Investigator Initiated Studies (ISS)
- Funding
- Protocol
- Team
- Clinic
- Safety data and concerns
- Contracts
[43:22] Other indications for MDMA include eating disorders with anorexia and binge eating disorder
[44:59] Rebecca accidental entry into clinical research, the joy of being a clinical site monitor, and a powerful patient story
[52:09] CRA skills working on MDMA studies (experience, ICH, GCP, mission aligned, solution focused, dynamic, passionate, smart, excited)
[53:52] CRCs are doing more than data entry. They are site managers and keeping the site on track
Resources Mentioned The early use of MDMA (‘Ecstasy’) in psychotherapy (1977–1985)
U.S. Food and Drug Administration
Breakthrough Therapy designation
Special Protocol Assessment
Approved Risk Evaluation and Mitigation Strategies (REMS)
Drug Enforcement Administration (DEA)
Donate to MAPS nonprofit organization / 501(c)(3)
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Novartis
MAPS on Facebook, Instagram, LinkedIn
Sign up MAPS Newsletter
MAPS Resources
MAPS Research (clinical trial data)
Acid Test: LSD, Ecstasy, and the Power to Heal by Tom Shroder
People Mentioned
Alexander Shulgin
Leo Zeff
Nancy Reagan
Amy Emerson (CEO of MAPS Public Benefit Corporation)
The post Psychedelic Clinical Trials with Rebecca Matthews appeared first on Clinical Trial Podcast & Blog.
Almost everyone I’ve met in clinical research has accidentally discovered this hidden profession.
Your interest in science and medicine somehow got you involved in clinical research and clinical trial management.
But didn’t you wish you had a crystal clear understanding of “Who’s Who In Clinical Research?”
That’s when this post comes handy.
Clinical Research is sometimes also referred to as Medical Affairs or Clinical Affairs.
Aside from the naming nuances, the pillars of clinical research remain the same. This is true for pharmaceuticals, medical devices, and biologics.
In this post, you’ll learn the functional areas that form an ideal clinical research team at a sponsor or clinical research organization (CRO).
For each function, I’ve highlighted why the group exists and their general mindset.
We’ll wrap up our discussion with adjacent departments that interact with clinical research professionals.
So let’s get started:
Clinical Project Management I’d like to start with my personal favorite clinical research role, Project Management.
The reason why the project management role is so interesting is because it provides a holistic view of clinical trial management and clinical research.
“General Contractor” for the study The project management team is made up of Clinical Project Managers and Program Managers.
In some companies, Clinical Project Managers (CPM) may be referred to as Clinical Trial Managers (CTM) or Study Managers.
Project managers are the “General Contractors” of clinical research. They are accountable of all aspects of a clinical trial.
Go-to person for clinical trial budget, timelines, resources Developing and actively managing clinical trial finances, timelines, and resource allocation is necessary for a smooth trial execution. This responsibility falls under the project management team.
After mapping out trial assumptions such as number of sites, patients, enrollment period, monitoring, a project manager will develop the study budget and timeline with key milestones.
Depending on the size and reporting structure of the company, project resources are either managed by the project manager or by functional managers.
Clinical project manager is able to connect the dots A great project manager is able to connect two seemingly unrelated issues and assess the impact on the project.
Let me give you an example.
Say you’re in the midst of securing FDA approval to start a new clinical trial. You find out that the FDA has follow-up questions. This is going to delay the First Patient In (FPI) date. Your investigational devices with limited shelf-life are ready to be shipped to the sites.
A great PM will recognize the downstream effects of study startup delays. For example, she’ll start planning for the additional devices. Not only that but the PM will also adjust the study budget.
Want to refer to this later? Get this 19-page guide sent to your inbox now. Clinical project manager anticipates issues In addition, to be able to connect the dots, a project manager also anticipates issues.
For instance, a clinical site may be enrolling at a rapid pace. During a periodic data review meeting, the project manager finds out that the site has a significant number of protocol deviations.
Rather than letting the clinical site continue enrollment, the PM decides to put the site enrollment on hold until the compliance issues are fully addressed and resolved.
The PM anticipates the negative impact of compliance issues on the overall trial. If the PM does not anticipate the issue, it could have negative consequences on the final results and major audit findings for both the sponsor and the clinical site.
Clinical project manager can visualize and paint the big picture A clinical trial has many moving parts. The objective of most trials is secure product approval, indication approval or assess the long term safety of the product after it is approved.
Keeping this end goal in mind, a clinical project manager needs to have a thorough understanding of the key milestones. If challenges arise (which they will), the project manager needs to communicate the challenges effectively to the right stakeholders.
It is also not uncommon for a project manager to paint the big picture for the team. This is necessary to prevent the team from digressing on irrelevant topics or getting distracted.
Clinical project manager is not afraid to get his/her hands dirty When I started my career, I felt that the project manager’s primary job was to tell other people what to do and by when it needs to be done.
That certainly did not turn out to be true.
Most of us desire a “perfect” project with no issues or challenges. This is however not reality.
There will be obstacles along the way that a project manager will need to overcome.
For example, let’s consider a clinical site that urgently needs investigational devices to enroll a patient the next morning. Unfortunately, the FedEx package drop-off time is 4:00 pm and the pick-up truck has left for the day. The only way to get the device to the site in time for the procedure is to drop off the device package to the airport. A great project manager would drive to the airport and drop off that package.
There are countless such scenarios where the project manager would need to roll up the sleeves and get to work.
Internal Clinical Operations – In-House Clinical Research Associate (CRA) Depending on the organization structure, Operations may be rolled up into Project Management or be a separate function.
Operations may be further subdivided in Internal Operations and External Operations. Members of the operations team usually have titles such as clinical research associate or clinical research manager.
CRA champions site start-up The in-house operations team is primarily responsible for clinical trial site start-up. This team ensures that each site has the most recent version of the site start-up packet. The start-up packet consists of the protocol, ICF template, and other study specific documents.
The in-house operations team also facilitates clinical contract negotiation with the site, which includes the study budget.
CRA understands devil is in the details Once the study-specific ICF template is sent to the sites, the site’s personnel review and edit the ICF to meet their site-specific IRB/ Ethics Committee requirements. The redlined ICF is then sent to the in-house operations team for final review and approval.
Similar to the ICF redlines, the CRAs also receive redlines on the clinical contracts.
This means that in-house operation is constantly inundated with multiple documents and redlines. This requires the in-house team to be detailed oriented and organized. An error can have significant ramifications including potential audit findings or lawsuits.
CRA’s life revolves site management and support The in-house operations team is available for site management and support. Aside from ICF and clinical contract questions, it is usual for sites to contact their in-house CRA with questions about clinical protocol, study specific requirements, investigational device restocking, and more.
Want to refer to this later? Get this 19-page guide sent to your inbox now. Field Clinical Operations – Field CRAA field operations team is composed of field clinical research associate (CRA) and clinical research managers.
Field CRAs are also known as monitors.
In-house operations and field operations roles can sometimes overlap. In some organizations, field and in-house operations teams are combined into one group, namely Clinical Operations.
CRA is the face of the study for clinical sites A field team is the “face of a study” for a clinical site. Most field operation team members work remotely from their home office. They travel to clinical sites on a regular basis for monitoring and site support.
The field CRA is also responsible for conducting pre-study visits, site initiation visits and study close-out visits.
CRA understands devil is in the details A field CRA is responsible for monitoring clinical trial data at the site.
A field CRA needs to have thorough understanding of the study protocol, Good Clinical Practice (GCP) and regulations applicable to the conduct of clinical trials.
A clinical trial database has numerous fields. Depending on the monitoring plan, a CRA needs to review and verify the accuracy of the source data at the site.
For example, the CRA ensures the patient informed consent was signed prior to the procedure, serious adverse events were reported on time or protocol deviations were addressed appropriately. This work requires attention to details and deep focus to be done right.
CRA helps site succeed on all fronts – start-up, enrollment, compliance Site coordinators can get overwhelmed with multiple trials. Many clinical sites are also nonprofit organization with limited funding and resources to support clinical research.
A field CRA can help their clinical site be successful by promptly answering all questions during study start-up, enrollment and follow-up.
In addition, it’s not uncommon for a CRA to prep sites prior to any scheduled audits.
The job of the field CRA is not “police” the site but rather be the site’s champion and help a site be successful in their research efforts.
Want to refer to this later? Get this 19-page guide sent to your inbox now. Clinical Data Management (CDM) & ProgrammingHere’s the deal.
Products are brought to market based on clinical data. Government agencies, medical community, and patients believe in the power of data.
It is no easy task to collect and clean hundreds of clinical trial data points in a compliant manner. This is where the data management team comes to play.
Data manager decides how data will be collected and cleaned One of the key responsibilities of a data manager is to develop case report forms (CRF) for the collection of clinical trial data. These days most data is collected via electronic data capture (EDC) forms.
A well-designed and thought out CRF can be of great value to the sponsor in the long run.
For example, data collected in a case report form can not only help secure product or indication approvals but also forms the basis of publications and presentations.
Data manager’s life revolves around database locks Once all patients have completed their primary endpoint visit and the data has been cleaned, the final step is to lock the database.
Database lock is a very important milestone not only for data management but also for the entire organization.
Database locks can be a very stressful time for data managers, sites and CRAs. The CRAs are frantically working with the clinical sites to resolve open queries. A database is usually not locked till open queries are resolved.
Once the database lock occurs, the biostatistics is able to analyze the data and generate tables and graphs.
Data manager communicates study metrics Without data metrics, you would have no way of knowing whether your sites are completing the CRFs in a timely manner.
Let’s consider a 1000 patient clinical study at 65 sites with 3-year patient follow-up. For each patient there are 20-30 case report forms with multiple fields in each form. It becomes increasingly complex to determine what data is missing, incorrectly entered or not available.
A data management team can create custom reports that can provide data metrics by site, by visit or by patient. This information makes it efficient for sites and CRAs to address data entry gaps and query resolution.
Want to refer to this later? Get this 19-page guide sent to your inbox now. Biostatistics (or Biometrics) Statisticians are the numerical brain behind a clinical study. Statistics is a very broad field with numerous data analysis methods.
Biostatistician is the key driver behind trial design One of the key components of clinical trial design is the sample size. Simply speaking, you want to know how many patients are needed in order for the clinical study to be statistically sound.
For many studies, regulatory agencies review the statistical analysis plan (SAP) as part of the trial design review.
Life revolves around p-values, trial power and performance goals P-values, power and performance goals are the geeky pieces of information that statisticians care about.
Statisticians want to understand if the trial results (good or bad) are replicable in the real world.
They attempt to understand the probability of the certain benefits or risks to re-occur in real world once the medical products are commercially available.
Shares clinical study results using tables and graphs The Statistical Analysis Plan (SAP) specifies how the data will be analyzed.
Once the clinical data is analyzed, it is presented beautifully in the form of tables and graphs. This is a key task as it forms the foundation of how the trial results will be communicated to the outside world.
Tables are graphs utilized in clinical summary reports, annual updates, presentations and publications. Tables and graphs are also included on product Information For Use (IFU) documents and Patient Guides.
When the product is approved to be sold commercially, sales and marketing teams use government approved tables and graphs to promote the use of the drug or device.
Clinical Safety This is a very interesting role for anyone who wants to be closest to the medical aspects of any clinical trial.
Safety touches most aspects of a clinical trial including the protocol, patient informed consent, patient safety outcomes in the final study report, Instructions for Use (IFU) document and more.
Understands regulatory requirements around patient safety Regulatory agencies are most concerned about the safety of the clinical trial procedure and investigational device or drug.
The safety team has a thorough understanding of regulatory requirements pertaining to the safety of any clinical trial.
When patients are enrolled in a clinical trial, they may experience an adverse event. Clinical sites, sponsors and CROs are required to meet strict adverse event reporting requirements. Adverse event reporting requirements can vary by country.
A safety team member has a clear understanding of regulatory requirements and helps ensure safety compliance.
Life revolves around adverse events management A safety monitor champions all safety aspects of a clinical trial such as adverse events, clinical trial procedure risks, and device/ drug risks.
When a patient participates in a clinical trial, he or she may experience adverse events, also known as AEs. These AEs are reviewed by the safety team.
In some cases, there may be unexpected serious adverse events (SAEs) that may impact patient safety. When such events occur, the safety team evaluates and communicates the adverse event information with stakeholders such as clinical trial sites, patients, and regulatory agencies.
Manages Clinical Events Committee (CEC) and Data Monitoring Committee (DMC) When patients experience AEs, the clinical sites reports the AEs to the trial sponsor or CRO. The safety team reviews reported AEs and collects relevant medical records.
A subset of these AEs and the corresponding relevant medical records are sent to a physician committee, known as the Clinical Events Committee (CEC). The safety team manages the selection and operation of a CEC.
The basic premise of a clinical trial is that it’s a drug or medical device experiment on human beings. Participation in a clinical trial usually involves safety risks. Some safety risks are anticipated and others aren’t.
For unanticipated risks during the enrollment phase, a sponsor may recruit a data safety monitoring board (DMC). The DMC ensures there is no risk to patients in the trial.
Not all trials require DMC as the duration of enrollment might be too small to detect a safety signal. Similar to CEC, the safety team leads the selection and management of a DMC.
Want to refer to this later? Get this 19-page guide sent to your inbox now. Clinical Quality Throughout my career, I’ve worked with clinical quality experts that either “police” every step in the clinical process or serve as a partner and resource to other clinical research functions.
In both cases, the ultimate goal of any clinical quality personnel is to keep you, your clinical trial and your organization out of trouble.
Ensures compliance in all aspects of a clinical trial As we’ve discussed earlier, clinical research is a highly regulated industry. With regulations, comes compliance. Clinical research professionals need to comply with government regulations, Good Clinical Practice (GCP) and operating procedures.
You may ask, “What’s the purpose of all this compliance”?
Well, the simple answer is that the outcome of a clinical trial sets a new medical standard or leads to an update of an existing medical standard.
Would you trust a drug or device that is brought to market based on a non-compliant clinical trial?
Probably not.
Clinical quality wants no audit Findings Passing an audit is the ultimate test of any clinical research organization. This is especially true for audits by regulatory agencies.
Audit findings are painful not just for the quality team but for the entire clinical team. Significant audit findings also raise doubts about the robustness of a clinical trial.
Life revolves around Standard Operating Procedures (SOPs) For instance, in the US, FDA regulations dictate how a clinical trial should be conducted. These regulations form the basis of standard operating procedures (SOPs).
A great quality associate helps a clinical research organization create and maintain a practical set of SOPs.
It is important to note that the burden of creating SOPs does not lie with clinical quality. Other clinical research functions are responsible for drafting and finalizing their own role-specific SOPs.
Understands Corrective and Preventive Action Plan (CAPA) Since many aspects of clinical trials are managed by humans, the process is prone to errors. Errors can happen due to oversight, gap in a SOP, or mismanagement. A quality personnel initiates a CAPA when errors are discovered.
The goal of a CAPA is to document the error and take necessary steps prevent the error from happening in the future.
CAPAs are frowned up and are never a good thing for any organization. More CAPAs means there is greater risk, which in turn reduces the public’s confidence in the clinical trial outcomes, product or company.
Medical Writing Clinical trial information is communicated with all stakeholders via clinical documents such as the protocol, clinical reports and manuscripts.
A medical writer leads the task for assimilating trial information and putting it together in a logical way.
Understands scientific content A medical writer has an in-depth understanding of the therapeutic area and previous clinical and preclinical information on the drug or device.
Given the countless number of medical products and trials, it’s not unusual to learn trial or product specific information after joining the project.
Life revolves around writing protocols, reports or manuscripts As a medical writer, you need to enjoy the process of writing. If you don’t enjoy writing, it will be painful to write several hundred pages of clinical trial documents on a regular basis.
A medical writer has a unique ability to communicate high-level clinical trial strategy vision in a document such a protocol or report.
Regulatory decisions are made based on these documents. Therefore it is extremely important for a writer to understand what regulators are looking for.
Detailed oriented with focus on punctuation, grammar and formatting A medical writer is responsible for writing key clinical documents such as the protocol, clinical reports, safety charters, and more.
Punctuation, grammatical errors or typos can reduce the reviewers trust in the final document. Such errors make the company look sloppy in front of regulators, clinical sites or trial sponsor.
Additionally, a medical writer needs to master writing software such as Microsoft Word. Inability to effectively use such software will cause issues with document formatting, resulting in delays and frustration.
Medical Science A scientist is responsible for the clinical trial strategy.
In some organizations, the role of the scientist may be combined with that of the medical writer or that of project management.
Brainchild behind the overall clinical strategy Prior to the start of any clinical trial, a lot of work is put into designing a cost-effective, safe and effective study.
Depending on the trial design, there may be quite a bit of back-and-forth between the regulator and the sponsor or CRO.
A clinical trial can begin enrolling patients only after the regulatory alignment is obtained.
The scientist champions the development of clinical documents and communication necessary to secure this regulatory alignment.
Life revolves around designing a trial that meets the primary endpoint If you remember your life as a student (or maybe you’re still a student), your final grade on the test depends on how well you do on the finals.
Along the same lines, the success of any clinical trial is determined on whether or not it meets a pre-specified primary endpoint.
The trial endpoints are clearly stated in the protocol. Once the primary endpoint is met, the medical product will most likely be approved for commercialization.
Medical science wants high-quality clinical trial data The success of a clinical trial is hinged on high-quality clinical trial data. But what does “high quality” mean?
High-quality data is error-free, accurate, and complete. Missing or incomplete data due to missed visits or sloppy data entry can cause headaches for many clinical stakeholders, primarily the clinical scientist.
Also, there can be a tendency to collect more data than needed for “just in case” scenarios such as unanticipated requests from regulators or potential for interesting publications in future years.
Clinical Systems and Solutions Not too long ago, clinical trial data was collected on paper case report forms. Then it became incredibly hard to manage data queries, keep track of complete forms and manual entry of data from paper into an electronic database.
With the help of technology, electronic data capture (EDC) solutions were developed. Now site staff can directly enter data in the case report forms.
The Systems and Solutions team is responsible for managing clinical technology solutions such as the EDC. They are also responsible for onboarding new technology solutions and retiring old solutions that no longer add value to the organization.
Technology backbone for clinical trials More than ever before, technology is becoming an integral part of clinical research. The system and solutions group is the technology backbone for clinical trials.
Want to incorporate wearable technology in a clinical study?
Or build an iPhone app to organize study team contact?
Clinical systems and solutions group is your go-to team.
Depending on the size of the company, this role may be a separate function within clinical research or part of the information technology (IT) organization.
Focused on clinical research software and applications Clinical research teams utilize a few core technology solutions such as the Trial Master File (TMF), Clinical Trial Management System (CTMS), Electronic Data Capture (EDC), Integrated Web/Voice Response System (IxRS), and electronic Informed Consent (eConsent).
The TMF allows you to store study and site level documents in electronic format.
CTMS is useful for managing study contact information, monitoring trip reports, site and vendor payments and more.
EDC allows sponsors to design electronic case report forms and allows sites to remotely enter data into the system.
IxRS serves to register patients to a specific treatment.
In addition, there may be other systems for safety management and reporting, protocol deviation and monitoring visit management.
Understands regulatory requirements for technology solutions Regulators are interested in ensuring clinical trial technology is compliant with the law.
At the most basic level, technology solutions need to maintain an audit trail, protect patient personal health information (PHI) and encrypt sensitive clinical trial information.
Systems and solutions teams need to have an in-depth understanding of regulatory requirements pertaining to technology solutions.
Regulators such as the FDA frequently publish guidance documents related to a specific technology product.
Guidance documents can be easily accessed via the FDA website and can serve as a great resource for anyone wanting to dig deep in a specific clinical technology area.
Want to refer to this later? Get this 19-page guide sent to your inbox now.
Senior Management Senior management is ultimately accountable for the success (or failure) of any clinical trial.
Key senior management functions in a clinical research organization include directors of each of the functional teams described above.
Depending on how the organization is structured, a clinical director may oversee more than one clinical trial or clinical function.
Accountable for all aspects of a clinical program Providing adequate oversight is the key role of a senior manager.
Oversight is not the same thing as “micro managing” an employee or a task. For certain critical deliverables, a senior manager may be more hands-on.
Strategic focus – Budget, Timelines, Resource Allocation, Procedure Compliance, Scientific Robustness Clinical trial costs can run into millions of dollars. By controlling project timelines and resources, a senior manager can control expenses.
In addition, it is crucial to ensure the trial is conducted in compliance with regulations and internal procedures.
Finally, if the study is not scientifically robust, the clinical trial may not get regulatory approval.
It is not possible for one individual to be competent in all these areas. For this reason, a senior management team is needed to collaboratively achieve strategic goals.
Interested in Key Performance Indicators (KPIs) Do you have a retirement account?
Or go to the doctor for an annual check-up?
If so, you’re probably paying attention to the performance of your retirement fund or your health over a period of time.
Along the same lines, senior managers are interested in a set of KPIs that track the performance of a clinical trial against a standard or threshold.
For example, regulators want to ensure patients sign the correct version of the informed consent form (ICF). Signing an incorrect ICF version is a major compliance issue. Thus ICF deviation rate can be a KPI.
Since senior managers are not involved in the day-to-day operations of the trial, they assess the health of a project by reviewing KPI metrics. If KPI metrics trend towards non-compliance, senior managers will take steps to address the issues.
Other Clinical Trial Stakeholders A clinical department frequently collaborates and seeks help from other teams. The section below covers the key teams that interact and support clinical teams on a regular basis.
Since the focus of this post is clinical research, the role of these adjacent functions has been described keeping in mind the clinical context.
Regulatory Affairs (RA) Regulatory Affairs (RA) is responsible for regulatory strategy and submissions. For a clinical trial, a RA team member is generally the primary contact person for the regulator such as the US FDA, Japan PMDA, China FDA.
Deep understanding of regulatory process and requirements Ready to start a clinical trial? Or address clinical trial deficiencies with the regulator?
You’ll want to start with your regulatory affairs team. Clinical trials are conducted in compliance with regulations. RA can educate you on the clinical documents needed to meet regulatory requirements in a given geography.
A regulatory affairs expert has an in-depth understanding of the regulatory process and requirements.
Adept at reviewing and editing clinical submission documents Once the clinical team has created the necessary documents such as the protocol, statistical analysis plan or the clinical summary report, a regulatory affairs associate performs a detailed review of the documents.
In addition, regulators have specific formatting requirements such as cover letters and forms that need to be completed with every submission.
Focus is on regulatory agency alignment on all aspects of clinical research There is a specific way of communicating clinical trial information with regulators. This communication style is very different from the day-to-day communication amongst clinical research team members. A seasoned regulatory affairs expert understands this nuance and is able to communicate effectively with regulators.
Seeks new medical product/indication approvals Success of a regulatory affairs team is measured by product and indication approvals. It’s no easy task to get a product to market, especially for new therapies.
Health Economics and Outcomes Research (HEOR) Getting medical products or indications approvals is always great news.
But here’s the deal.
You need someone to pay for the approved drug or device. If payors such as insurance companies or Medicare are not willing to provide the reimbursement, it can significantly hurt a company’s bottom line.
This is where HEOR comes into play. A HEOR team helps create a body of evidence that the new drug or device has health benefits such as improved quality of life.
Deep understanding of payor process and requirements A HEOR expert can help you develop a robust protocol and case report, so you can proactively collect the clinical data needed for reimbursement.
HEOR has an in-depth understanding of country-specific requirements. Their work leads to maximum medical product reimbursement for the company.
Understands medical product impact on Quality of Life (QoL) Let’s say your friend experienced a heart attack and got a stent. Now 10 years have passed. Your friend has not experienced any new heart problems. He feels great, goes for a morning run and is able to spend quality time with his family.
How would you rate his quality of life? Excellent, right?
HEOR pays much attention to a patient’s quality of life. In addition to being safe and effective, medical products need to have a positive impact on a patient’s quality of life.
There are many tools available to measure such quality of life. Clinical trials include quality of life questionnaires for patients to complete. This data is then analyzed and utilized to secure reimbursement approvals.
Seeks to maximize medical product reimbursement One of the primary roles of the HEOR team is to ensure the medical product receives maximum reimbursement possible.
Reimbursement can vary significantly based on country laws or availability of new health data. For example, Japan offers higher reimbursement for newer medical products but then decreases reimbursement in future years.
Clinical Research Organizations (CROs) and Consultants Some sponsors hire full-time staff to manage their trials. Some outsource all clinical research tasks to CROs and consultants. While others may use a combination of internal and external resources.
Supports sponsor by filling in resource and talent gaps It is expensive to build a full clinical team, especially for an organization with limited financial resources. CROs can help fill the talent gap for each of the clinical research roles discussed in this post.
Work is billable A major chunk of clinical trial costs is full-time salaries paid for each of the clinical roles explained in this post.
CROs and consultants charge by the hour or by deliverable. The “pay by the hour” or “pay by deliverable” model gives sponsors greater flexibility and control on expenses.
People that work for a CRO may be full time employees or contractors. At any given time, a CRO or a consultant may be working on multiple projects for different sponsors.
Can help reduce fixed overhead expenses For smaller organizations, steady cash flow can be an issue. Therefore having a full clinical team means paying for employee salaries, office space, health insurance and other benefits. This can be cost prohibitive.
Hiring a CRO or consultant can reduce fixed expenses, giving companies greater flexibility with their limited resources.
Legal Clinical research cannot be conducted without legal support.
You’d open yourself to all sorts of risks if you didn’t have a lawyer on your team.
Complete understanding of legal landscape A lawyer with clinical research experience has an understanding of intellectual property law (patents, trademarks), legal entities i.e. how the hospitals or suppliers are structured from legal standpoint, supplier contracts, subject injury and liabilities, and more.
Seeks legal compliance in a clinical trial A lawyer will be extremely happy if a company is successfully able to conduct a clinical trial in a legally compliant manner.
For instance, there is great risk to patients participating in clinical trials. If the legal language on the informed consent form or clinical trial contract between the site and sponsor is inadequate or unclear, it can lead to lawsuits.
Lawsuits impact the company’s finances, brand and reputation. A legal team ensures the company does not end up in legal troubles with any of the clinical trial stakeholders.
Want to refer to this later? Get this 19-page guide sent to your inbox now. Conclusion By now you have an in-depth understanding of all clinical research functions and teams that support clinical trials.
Clinical research and clinical trial management involve cross-functional teams. The chart below summarizes the roles of different clinical research team members.
Which clinical research function interests you the most? Leave your response in the comments section below.
Want to refer to this later? Get this 19-page guide sent to your inbox now.
The post 15 Clinical Research Job Roles & Responsibilities (2021) appeared first on Clinical Trial Podcast & Blog.
Do you want to know more about diversity in clinical trials?
Are you a Sponsor looking to develop a robust clinical trial strategy?
Would you like to develop foundational skills as a clinical research scientist?
If you answered “Yes” to any of these questions, then this interview with Jennifer Jones-McMeans will serve you well.
Jenn currently serves as the Program Director for cardiovascular studies at Abbott Medical Devices.
She has played a key scientific role in some of the largest drug eluting stent clinical trials from trial design to publications and presentations.
It’s because of Jenn’s direct contributions as a scientist and scientific program director, many cardiology medical devices received FDA PMA approval or 510(K) clearance.
Most recently, Jenn has been involved in Abbott’s efforts in designing studies that include a diverse group of underserved clinical trial participants.
As an African American woman, mother, and wife, she is an inspiration and role model for women interested in developing their career in clinical research.
My interview with Jenn touches on a variety of topics including diversity and inclusion in clinical trials, developing a clinical trial strategy, working with key opinion leaders, skills you need to grow your career as a clinical scientist, and much more.
I hope you enjoy my interview with Jennifer Jones-McMeans on the Clinical Trial Podcast.
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Show Notes [4:05] Jenn’s background as a Ph.D. student in exercise physiology, what is a biomarker, Jenn’s family background in the field of medicine
[6:22] Jenn’s first clinical research job after college studying blood pressure drug therapies
[7:18] Transition from academic to industry i.e. Abbott Laboratories
[8:30] The role Jenn’s childhood played in her career, the difficulty her grandfather faced to pursue medical degrees as an African American, and Jenn’s father’s experience in internal medicine as a physician assistant
[10:54] Medicine is global then why can’t it be that those who are providing care are doing the research to ensure that there is care through therapies, look like all of us who get treated.
[12:54] Jenn’s current role as a scientific program director at Abbott Vascular where her team is responsible for a portfolio of cardiology medical devices that treat the blood vessels and getting them approved, designing and conducting clinical trials, presenting the data, writing up the data, and interpreting the data
[14:09] How do we make our clinical trials more equitable?
[15:38] Factors that impact diversity and inclusion in clinical trials
- Identify clinical sites that are in areas where many of these patients may be underserved
- including physicians and research sites that actually look like the patients that that that are serving those communities
[16:34] There is a lack of understanding among patients about what is a clinical trial. We need to educate patients about clinical trials (clinical care opportunity).
[19:09] Dealing with patient’s lack of trust
[21:41] Site selection and physician education as it relates to enrolling diverse patients in a clinical trial
[23:49] Developing a clinical trial strategy
- Understanding the disease state and unmet need
- What is the standard of care and what is contemporary care?
- What is the business objective? Consider budget, timelines, resources, regulatory expectations
- Identifying physicians that are going to work with you, their current day to day practice, and how it’s going to change as a result of the trial and/or medical product
[27:40] How do we know we have the right physicians to help us out with our clinical strategy?
[29:23] 29:23 Making medical device clinical trial decisions keeping in mind the patient and how not to get lost when writing the protocol
[32:53] Understanding patients of certain disease states and what is their general hospital expectations of having to come back to see their physician
[35:43] What are some of the lesser known but important considerations when it comes to protocol compliance?
- Understanding the burden on the site
- Inclusion and exclusion criteria too rigorous
[38:47] Navigating relationships with your Key Opinion Leader (KOL)
[40:24] Foundational skills for a clinical research scientist
- Understanding research methods, questions, hypotheses, and data interpretation
- Creative curious problem solver
- Wanting to learn
- Be an independent thinker
- Be able to work in the team
- Caring
[42:54] Developing skills through experience and time, and paring new team members with individuals with experience and knowledge
[45:04] Acquiring new knowledge through reading journal articles and exchanging information (discussing) with an expert and/or peers
[49:01 Advice for people who feel that the cards are stacked against them. Ask the following questions:
- What do I want?
- What do I need to get there?
- Where is the gap?
- What’s missing?
- Who can help me get there?
Resources Mentioned University of Texas Southwestern Medical Center
University of Maryland
Abbott Laboratories
University of California, San Francisco
Food and Drug Administration
Starbucks frounder Howard Schultz
Medpage Today
TCT MD
[Book] Seven and a Half Lessons About the Brain by Lisa Feldman Barrett
Lisa Feldman Barrett’s TED Talk
Your Brain is Not For Thinking
Peace Is Every Step: The Path of Mindfulness in Everyday Life by Thich Nhat Hanh
Mindful of Race: Transforming Racism from the Inside Out by Ruth King
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