NIH Collaboratory: Recent Episodes

NIH Pragmatic Trials Collaboratory

This podcast covers topics from the NIH Collaboratory Grand Rounds series related to advances in clinical research, particularly pragmatic clinical trials and clinical research that engages healthcare delivery systems as partners. Visit rethinkingclinicaltrials.org to learn more.

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Drs. Steven George and Christine Goertz discuss slow recruitment mitigation strategies, one of the small group discussion topics at the NIH Pragmatic Trial Collaboratory's Steering Committee meeting in April 2026. Review the Steering Committee Meeting materials: https://rethinkingclinicaltrials.org/news/april-2026-annual-steering-committee-meeting/

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Drs. Brad Hammill and Keith Marsolo discuss the use of death as an endpoint, a section in the Living Textbook chapter on Choosing and Specifying Endpoints and Outcomes.Read the chapter: https://rethinkingclinicaltrials.org/chapters/design/choosing-specifying-end-points-outcomes/choosing-and-specifying-endpoints-and-outcomes-introduction/

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Roy Perlis of Harvard Medical School and JAMA+ AI expands on key takeaways from his recent Grand Rounds presentation, “Keeping a Human in the Loop: Scientific Publishing and AI.”

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Majid Afshar and Mary Ryan Baumann discuss the conduct and results of their pragmatic trial.

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Drs. Jonathan Moyer and David Murray discuss their recent publication, “Evaluating Analytic Models for Individually Randomized Group Treatment Trials With Complex Clustering in Nested and Crossed Designs.”

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as well as the new Living Textbook Chapter on Decentralized Pragmatic Clinical Trials.

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Dr. David Zaas discusses key takeaways from his recent keynote presentation: “Landscape of Healthcare in America: Gaps and Opportunities (That Researchers Need to Hear).

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also known as the INSPIRE trial.

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Drs. Sebastian Tong and Julie Fritz expand on key takeaways from their recent Grand Rounds presentation.

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Avoiding the Fumble: Building on a Decade of Lessons from Pragmatic Clinical Trials.

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Drs. Greg Simon and Lorella Palazzo discuss their recent Living Textbook Chapter, "End-of-Trial Decision-Making."Read the chapter: https://rethinkingclinicaltrials.org/chapters/dissemination/end-of-trial-decision-making/introduction-end-of-trial-decision-making/

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Drs. Pearl O'Rourke and David Wendler discuss their recent publication, "Disentangling Informing Participants From Obtaining Their Consent."

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Drs. Lesley Curtis and Keith Marsolo discuss the new learning module "Healthcare Data Interoperability and Standardization for Research."

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Drs. Rich Platt, Hayden Bosworth, and Greg Simon consider how to make pragmatic trials more pragmatic.

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Dr. James Tulsky and Dr. Angelo Volandes discuss "Advance Care Planning: Promoting Effective and Aligned Communication in the Elderly," also known as the ACP PEACE trial.

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Dr. Pearl O'Rourke and Dr. Stephanie Morain discuss waiver or alteration of informed consent for minimal risk clinical investigations.

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Dr. Michael Pencina and Dr. Brian Anderson discuss Public-Private Partnerships in the Trustworthy Health AI Ecosystem.

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Dr. Harlan M. Krumholz and the PaxLC research team discuss Digital, Decentralized and Democratized: Lessons From The Yale PaxLC Trial.

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Dr. Julie Fritz discusses "BeatPain Utah: Partnering with Community Health Centers Within a Socio-Technical Framework."

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Dr. Joshua Denny discusses the All of Us Research Program: Improving Health Through Diverse Technology, Huge Cohorts, and Precision Medicine.

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Drs. Russell Rothman and Erin Holve discuss a decade of research in PCORnet®.

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Dr. Michael Gibson discusses The Heartline Trial and a new paradigm in conducting virtual clinical trials.

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This podcast continues the discussion with Dr. Emily Largent as she discusses ethical considerations for vulnerable populations participating in pragmatic clinical trials.

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Dr. John Concato discusses the 2021 FDA draft guidance on real-world evidence.

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Dr. Christopher Lindsell discusses research outcomes and the importance of choosing the correct outcome.

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This podcast continues the discussion with Diana Berrent, JD, and Nick Guthe, founder and member of Survivor Corps, and Natalie Lambert, PhD, of the Indiana University School of Medicine, as they describe best practices for medical professionals treating patients experiencing debilitating effects of COVID-19.

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Dr. Boineau moderates a discussion with Drs. Chambers, Curtis, O'Brien, Weber, and Zimmerman about increasing diverse participation in pragmatic clinical trials.

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This podcast continues the discussion with Dr. Adrian Hernandez and Dr. Megan L. Ranney about using digital technologies in clinical trials and best practices for online participant recruitment.

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In this episode of the NIH Collaboratory Grand Rounds podcast, Dr. Adrian Hernandez speaks with Dr. Susan Ellenberg of the University of Pennsylvania about the challenges encountered by the Data and Safety Monitoring Board overseeing a group of COVID-19 vaccine trials under the National Institutes of Health.

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In this episode of the NIH Collaboratory Grand Rounds podcast, Dr. Adrian Hernandez speaks with Dr. Kevin Schulman of Stanford about strategies for promoting widespread COVID-19 vaccination in the United States.

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In this episode of the NIH Collaboratory Grand Rounds podcast, Dr. Adrian Hernandez speaks with Dr. Emily O'Brien of the Duke Clinical Research Institute about the HERO-TOGETHER study that is evaluating how people do over time after receiving the COVID-19 vaccine.

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This podcast follows the conversation between Dr. David Boulware and Dr. Adrian Hernandez as they discuss the complexities of conducting virtual clinical trials during the COVID-19 pandemic.

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This podcast follows the conversation between Dr. C. Michael Gibson and Dr. Adrian Hernandez as they discuss how open access, patient empowerment, social media, and digital health are transforming clinical trials.

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This podcast, led by Wendy Weber, ND, PhD, MPH, features a reflective conversation with Lesley Curtis, PhD, Patrick Heagerty, PhD, and Keith Marsolo, PhD, focused on the Grand Rounds EHR workshop series, “Advances at the Intersection of Digital Health, Electronic Health Records, and Pragmatic Clinical Trials.”

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This episode of the NIH Collaboratory Grand Rounds podcast follows the conversation on Electronic Health Records (EHRs) between Dr. Lesley Curtis and Dr. Joshua C. Denny, Chief Executive Officer of the All of Us Research Program. The discussion covers questions on Dr. Denny’s early experience with EHRs, his journey on working with All of US and EHRs, and how the program is addressing the impact of the COVID-19 pandemic. This discussion follows Dr. Jacqueline Corrigan-Curay and Dr. Denny’s keynote presentation of a Grand Rounds Series titled Advances at the Intersection of Digital Health, Electronic Health Records, and Pragmatic Clinical Trials.

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In this episode of the NIH Collaboratory Grand Rounds podcast, Dr. Lesley Curtis speaks with Dr. Robert Califf, Head of Strategy and Policy at Verily Life Sciences and Google Health about whether the COVID-19 crisis can lead to reformation of the current healthcare delivery system. This discussion follows Dr. Califf's keynote presentation of a Grand Rounds Series titled Advances at the Intersection of Digital Health, Electronic Health Records, and Pragmatic Clinical Trials.

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In this episode of the NIH Collaboratory Grand Rounds podcast, Dr. Adrian Hernandez speaks with Dr. Leora Horwitz of NYU Langone Health about creating a Learning Health System through randomization.

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In this episode of the NIH Collaboratory Grand Rounds podcast, Dr. Adrian Hernandez speaks with Dr. Mitesh Patel of University of Pennsylvania about using nudges in a healthcare system to “steer medical decision-making toward higher value and improved patient outcomes.”

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In this episode of the NIH Collaboratory Grand Rounds podcast, Dr. Adrian Hernandez sits down with Dr. Nigam Shah of Stanford University to discuss an informatics service called “Green Button,” which searches across diagnosis and procedure codes, concepts extracted from clinical notes, laboratory test results, vital signs, as well as visit types and duration of inpatient stays, to ultimately compare outcomes and guide practice.

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In this episode of the NIH Collaboratory Grand Rounds podcast, Dr. Adrian Hernandez sits down with Dr. Paul Harris to discuss REDCap integration with Fast Healthcare Interoperability Resources (FHIR). In the discussion, Harris covers past challenges of Electronic Health Record and Electronic Data Capture integration, progress in development of a new model, and current adopters of FHIR.

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In this episode of the NIH Collaboratory Grand Rounds podcast, Dr. Adrian Hernandez sits down with Drs. Rebecca Li and Frank Rockhold to discuss clinical trial data sharing and re-use. In the discussion, Li and Rockhold highlight benefits, potential fears, and the future of data sharing and open science as well as Vivli, a global clinical research data sharing platform.

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In this episode of the NIH Collaboratory Grand Rounds podcast, Dr. Kevin Weinfurt sits down with Craig Lipset to discuss the role and impact of digital in trials and its various roles. In the discussion, Lipset highlights displacement and its impact on traditional research models, the concept of digital twins, and opportunities that stakeholders have to address the barriers that exist for to meaningful adoption for of digital technologies in clinical research.

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Dr. Murali Doraiswamy discusses potential uses of artificial intelligence technologies in the field of mental health. (Audio track of the webinar.)

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In this episode of the NIH Collaboratory Grand Rounds podcast, Dr. Adrian Hernandez sits down with Dr. Rob Mentz to discuss balancing Good Clinical Practice Guidance and Pragmatic Trials in the Learning Health System. In the discussion, Dr. Mentz covers key challenges with good clinical practice (GCP), input from Dr. Rob Califf and others, and suggestions on how the scientific community should address the evolution of GCP versus the evolution of clinical trials.

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In this episode of the NIH Collaboratory Grand Rounds podcast, Dr. Adrian Hernandez sits down with Dr. Elise Berliner and Michelle Leavy to discuss the Development of Harmonized Outcome Measures for Use in Research and Clinical Practice. In the discussion, Dr. Berliner and Leavy explain the outcome measures framework and harmonizing outcomes in specific clinical areas.

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Podcast 21: The Pragmatic Airway Resuscitation Trial (PART) by NIH Pragmatic Trials Collaboratory

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Podcast 20: Perinatal Outcomes Associated with a Major Change in Gestational Diabetes Screening by NIH Pragmatic Trials Collaboratory

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Podcast 19: Validating a Computable Phenotype by NIH Pragmatic Trials Collaboratory

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Podcast 18: Data Linkage Within, Across, and Beyond PCORnet by NIH Pragmatic Trials Collaboratory

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Renee Mitchell, Terrie Reed, and Roseann White discuss the Medical Device Epidemiology Network’s RAPID and SPEED projects.

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Podcast 16: Returning Individual Research Results to Participants by NIH Pragmatic Trials Collaboratory

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Steve Steinhubl, Director of Digital Media, Scripps RTI,discusses a digital & pragmatic clinical trial that explores under diagnosed Atrial Fibrillation in large health population.

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In this episode of the NIH Collaboratory Grand Rounds podcast, Dr. Michelle Mello discusses a study she and Dr. Steven Goodman recently conducted to determine how clinical trial participants think about having their participant-level data widely shared. In her discussion with Dr. Lesley Curtis, Dr. Mello discusses study results, what she found most surprising, and how the study revealed takeaways for researchers and clinical trial sponsors.

Study results are published in “Clinical Trial Participants’ Views of the Risks and Benefits of Data Sharing” in the New England Journal of Medicine.

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Podcast 13: Rethinking University Research with State Data (Aaron McKethan, PhD) by NIH Pragmatic Trials Collaboratory

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Podcast 12: Exploring What is Possible with High-Quality Data. Examples from Flatiron Health by NIH Pragmatic Trials Collaboratory

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Podcast 11: Launching NESTcc to Improve use of Real-World Evidence in Medical Device Ecosystem by NIH Pragmatic Trials Collaboratory

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In this episode of the Collaboratory Grand Rounds podcast, Dr. George Hripcsak, Chair of the Bioinformatics Department at Columbia University, discusses the Observational Health Data Sciences and Informatics (OHDSI) Program with moderator Dr. Adrian Hernandez.  He describes the Program's vision to create accessible and reliable clinical evidence by gathering the clinical data of millions of patients globally. Dr. Hripcsak also talks about how listeners can "Join the Journey" and become part of the OHDSI research network, and help toward the generating high quality evidence needed to inform medical decision making.

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Moderator Dr. Adrian Hernandez speaks with Duke Forge Director Dr. Robert Califf about the opportunities and challenges for data science in an era where data is everywhere. Now that mobile phones and other portable electronic devices provide people with access to large amounts of data day or night, Dr. Califf addresses how researchers and health systems can ensure that accurate health information is reaching these audiences.

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Dr. Sean Tunis and Ellen Tambor discuss with moderator Dr. Kevin Weinfurt their findings on clinician attitudes towards research participation, and how and when to best engage them. They describe the need for involving clinicians in the planning of study design, and in closing feedback loops after studies are completed, in order to build clinicians’ trust that research does lead to quality improvement for their patients.

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Dr. Andrew Faucett of Geisinger describes the considerations for the return of genomic results to patients.

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Drs. Richard Platt and Christopher Granger speak with moderator Dr. Adrian Hernandez about the IMPACT-AFib atrial fibrillation trial and the role of the FDA’s Sentinel Inititative. In this trial, researchers used Sentinel pharmacy data to find eligible patients with at least one oral anticoagulation prescription fill, and the speakers describe how the platform provided them with an efficient and cost-effective way to access the data of over 80,000 potential participants.

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Dr. Harlan Krumholz of Yale University Medical Center speaks with the NIH Collaboratory’s Dr. Adrian Hernandez about the ways preprint servers can help accelerate scientific progress through greater access to research results.

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Dr. Greg Simon, principal investigator of the Suicide Prevention Outreach Trial (SPOT), and Susan Ellenberg, a member of the Collaboratory Regulatory/Ethics Core, speak with moderator Dr. Adrian Hernandez about the factors that determine the need for a Data and Safety Monitoring Board (DSMB) in pragmatic trials.

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Drs. Adrian Hernandez and Kevin Weinfurt, two NIH Collaboratory Co-PIs and podcast moderators, discuss their predictions and hopes for the NIH Collaboratory in the next year.

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Dr. Greg Simon of the Kaiser Permanente Washington Health Research Institute speaks with the NIH Collaboratory’s Dr. Lesley Curtis about the integration of machine learning into suicide prevention.

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Dr. Karen DeSalvo, former acting Assistant Secretary for Health and Human Services, speaks with the NIH Collaboratory’s Dr. Kevin Weinfurt about the factors other than healthcare systems than impact the health of our communities.