Podcast June 26, 2019: Good Clinical Practice Guidance and Pragmatic Trials: Balancing the Best of Both Worlds in the Learning Health System (Robert Mentz, MD)

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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Podcast April 16, 2019: Development of Harmonized Outcome Measures for Use in Research and Clinical Practice (Michelle Leavy, MPH, Elise Berliner, PhD)

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 February 19, 2019: Paramedic Airway Management in Out-of-Hospital Cardiac Arrest – The Pragmatic Airway Resuscitation Trial (PART) (Henry Wang, MD, MS)

In this episode of the NIH Collaboratory Grand Rounds podcast, Dr. Adrian Hernandez sits down with Dr. Henry Wang to discuss The Pragmatic Airway Resuscitation Trial (PART); a trial that took 10 years of hard work and diligence to complete. In his discussion, Dr. Wang explains the importance of the PART trial, the technique for seeking consent, lessons learned, and more.

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Podcast January 29, 2019: A Learning Health System Story: Perinatal Outcomes Associated with a Major Change in Gestational Diabetes Screening (Sascha Dublin, MD, PhD, Gaia Pocobelli, PhD)

In this episode of the NIH Collaboratory Grand Rounds podcast, Dr. Kevin Weinfurt sits down with Dr. Sascha Dublin and Dr. Gaia Pocobelli to discuss their study that focused on perinatal outcomes associated with a major gestational diabetes screening. In their conversation, Drs. Dublin and Pocobelli explain the need for the study, what they discovered, other potential methods for how the study could have been conducted, and hopes for how their findings will inform change.

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Podcast December 5, 2018: Validating a Computable Phenotype: Should Results Change a Trial’s Pre-Specified Primary Outcome? (Gregory E. Simon, MD, MPH, Susan M. Shortreed, PhD)

In this episode of the NIH Collaboratory Grand Rounds podcast, Dr. Lesley Curtis speaks with Dr. Gregory Simon and Dr. Susan Shortreed of the Kaiser Permanente Washington Health Research Institute. In their conversation, Drs. Curtis, Simon, and Shortreed discuss computable phenotypes and if results should change a trial’s pre-specified primary outcome. Drs. Simon and Shortreed explain how they used the Suicide Prevention Outreach Trial (SPOT) to explore this question, the process they followed, and the lessons learned.

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Podcast November 20, 2018: Data Linkage Within, Across, and Beyond PCORnet (Thomas W. Carton, PhD, MS, Keith Marsolo, PhD)

In this episode of the NIH Collaboratory Grand Rounds podcast, Dr. Lesley Curtis speaks with Dr. Tom Carton, of the REACHnet Clinical Data Research Network, and Dr. Keith Marsolo, of the Duke School of Medicine, regarding data linkage within, beyond, and across The National Patient-Centered Clinical Research Network (PCORnet). In their conversation with Dr. Curtis, Drs. Carton and Marsolo discuss the data linkage problem their trying to solve, specific steps taken, their developed action plan, and the associated challenges.

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Want to hear more from Renee Mitchell, Terrie Reed, and Roseann White? View the full Grand Rounds presentation.

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Podcast November 7, 2018: MDEpiNet RAPID and SPEED Projects: Leveraging Real World Evidence to Get Better, Faster, Cheaper Medical Devices for Physicians and Patients (Renee Mitchell, MT, CLS, Terrie Reed, MSIE, Roseann White, MA)

In this episode of the NIH Collaboratory Grand Rounds podcast, Renee Mitchell, Terrie Reed, and Roseann White discuss the MDEpiNet RAPID and SPEED Projects. In their conversation with Dr. Adrian Hernandez, Renee, Terrie, and Roseann discuss the concept behind the projects, the collaborative nature, associated challenges, next phases, and the future.

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Podcast October 1, 2018: Returning Individual Research Results to Participants: Guidance for a New Research Paradigm (Jeffrey Botkin, MD, MPH, Consuelo Wilkins, MD, MSCI)

In this episode of the NIH Collaboratory Grand Rounds podcast, Dr. Jeffrey Botkin and Dr. Consuelo Wilkins discuss returning individual research results to participants. In their conversation with Dr. Adrian Hernandez, Drs. Botkin and Wilkins emphasize the importance of returning results to participants, the present challenges, and hopes for the process in the next five years.

For more information, view the NASEM consensus report.

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Podcast August 7, 2018: A Digital Pragmatic Direct-to-Participant Clinical Trial for Identifying Underdiagnosed Atrial Fibrillation in a Large Health Plan Population (Steven Steinhubl, MD)

In this episode of the NIH Collaboratory Grand Rounds podcast, Dr. Steven Steinhubl discusses a digital and pragmatic clinical trial, mSToPS, that explores underdiagnosed atrial fibrillation in a large health plan population. In his conversation with Dr. Lesley Curtis, Dr. Steinhubl discusses what lessons were learned through the study, what he found most surprising, and the role that patient engagement played.

Read more about mStops in a recent JAMA article.

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Tune in for our next episode with Grand Rounds speakers Dr. Jeffrey Botkin and Dr. Consuelo Wilkins and their presentation “Returning Individual Research Results to Participants: Guidance for a New Research Paradigm” which will be posted the week of September 24.  

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Podcast July 17, 2018: Clinical Trial Participants’ Views of the Risks and Benefits of Data Sharing (Michelle Mello, JD, 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.

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Tune in for our next episode with Grand Rounds speaker Dr. Steven Steinhubl and his presentation “A Digital Pragmatic Direct-to-Participant Clinical Trial for Identifying Underdiagnosed Atrial Fibrillation in a Large Health Plan Population” which will be posted the week of August 6. 

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