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.

Podcast 37: Data and Safety Monitoring Boards for Trials of COVID-19 Vaccines: The Challenges

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.

Podcast 38: Online Recruitment in the Era of COVID-19: Pitfalls and Progress

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

Podcast 39: Inclusion of Diverse Participants in Pragmatic Clinical Trials

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.

Podcast 40: Survivor Corps: Long-Term COVID-19 Patient Engagement

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

Podcast 41: Searching for a Unicorn: Selecting Outcomes for Outpatient Trials

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 John Concato discusses the 2021 FDA draft guidance on real-world evidence.

Podcast 42: FDA Draft Guidance on Real-World Evidence

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

Podcast 43: Ethical Considerations for Vulnerable Populations in Pragmatic Clinical Trials

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

Podcast 44: The Heartline Trial: A New Paradigm in Conducting Virtual Clinical Trials

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

Podcast 45: From Observational Studies to Pragmatic Clinical Trials: Research in PCORnet®

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

Podcast 46: All of Us Research Program

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

Podcast 47: BeatPain Utah

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

Podcast 48: Digital, Decentralized and Democratized: Lessons From The Yale PaxLC Trial

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

Podcast 49: Public-Private Partnerships in the Trustworthy Health AI Ecosystem

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

Podcast 50: Waiver of Consent

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.

Podcast 2: Health is More than Healthcare

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.

Podcast 1: Preprints: What, Why Not, and How

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.

Podcast 9: Data Science in the Era of Data Ubiquity

Podcast 11: Launching NESTcc to Improve use of Real-World Evidence in Medical Device Ecosystem

Podcast 13: Rethinking University Research with State Data (Aaron McKethan, PhD)

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.

Podcast 14: Clinical Trial Participants’ Views of the Risks and Benefits of Data Sharing

Podcast 16: Returning Individual Research Results to Participants

Podcast 20: Perinatal Outcomes Associated with a Major Change in Gestational Diabetes Screening

Podcast 21: The Pragmatic Airway Resuscitation Trial (PART)

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.

Podcast 23: Good Clinical Practice Guidance & Pragmatic Trials in the Learning Health System

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.

Podcast 25: Preparing for Clinical Trial Data Sharing and Re-use: The New Reality for Researchers

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.

Podcast 27: It’s Time to Learn From Patients Like Mine

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.

Podcast 31: Real World Evidence: Contemporary Experience and Future Directions

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.”

Podcast 32: Reflection on Advances at the Intersection of Digital Health, EHRs, and PCTs

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.

Podcast 34: Lessons from Virtual Trials in Time of a Pandemic

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.

Podcast 35: HERO-TOGETHER

The NIH Pragmatic Trials Collaboratory Podcast provides a platform for discussions about interesting and timely issues in the field of pragmatic clinical trials. Featured guests include Grand Rounds speakers, representatives from NIH Collaboratory Trials, and thought leaders within the NIH Collaboratory and broader research community.

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