November 2, 2022: PCT Grand Rounds Welcomes CardioNerds This Friday

Headshot of Dr. Amit GoyalIn this Friday’s PCT Grand Rounds, Dr. Amit Goyal of the Cleveland Clinic will present “The CardioNerds Clinical Trials Network: Pairing Equitable Enrollment With Trainee Development.” The Grand Rounds session will be held on Friday, November 4, 2022, at 1:00 pm eastern.

Goyal is a fellow in interventional/structural cardiology at the Cleveland Clinic and a cofounder of CardioNerds, an initiative to democratize cardiovascular education. The CardioNerds Clinical Trials Network pairs equitable clinical trial enrollment with the personal and professional development of fellows in training.

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October 19, 2022: This Week in PCT Grand Rounds: Protecting Patients and Research From Disinformation, Cyberthreat, and Choice

Headshots of Eric Perakslis and Andrea DowningIn this Friday’s PCT Grand Rounds, Eric Perakslis of Duke University and Andrea Downing of The Light Collective will present “Disinformation, Cyberthreat, and Choice: Protecting Patients and Clinical Research From the Digital Triple Threat.” The Grand Rounds session will be held on Friday, October 21, 2022, at 1:00 pm eastern.

A professor of population health sciences at Duke University, Perakslis is the chief science and digital officer of the Duke Clinical Research Institute and the chief research technology strategist in the Duke University School of Medicine. Downing is a cofounder of The Light Collective, a coalition of patient networks that advocates for the rights and interests of patient communities in healthcare technology.

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October 12, 2022: Ethics and Regulatory Grand Rounds Series Continues This Friday

Headshots of Joe Ali, Tanya Matthews, and Leslie CroffordThis Friday’s PCT Grand Rounds will feature the next installment of our special Grand Rounds series, Ethical & Regulatory Dimensions of Pragmatic Clinical Trials. Joe Ali, Tanya Matthews, and Leslie Crofford will present “Responding (or Not) to Signals of Potential Clinical Significance in Pragmatic Clinical Trials.”

The Grand Rounds session will be held on Friday, October 14, 2022, at 1:00 pm eastern.

Ali is an assistant professor of international health at Johns Hopkins University, Matthews is director of human research protections at Kaiser Permanente Washington, and Crofford is professor and chair of medicine at Vanderbilt University. Crofford is also a co-principal investigator for FM-TIPS, an NIH Collaboratory Trial.

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This special Grand Rounds series will include an additional 4 moderated webinar discussions with panels of experts. The sessions will focus on a range of topics, including the ethics of data sharing; ethical and regulatory considerations in the design and conduct of pragmatic trials; pragmatic research involving patients with dementia; and the use of waivers and alterations of consent. Read the full program.

October 5, 2022: PCT Grand Rounds to Feature Randomized Trial of Intraoperative Anesthesia Handovers

Headshot of Dr. Melanie Meersch-DiniIn this Friday’s PCT Grand Rounds, Dr. Melanie Meersch-Dini of University Hospital Münster (Germany) will present “Impact of Handovers of Anesthesia Care on Morbidity and Mortality.” The Grand Rounds session will be held on Friday, October 7, 2022, at 1:00 pm eastern.

Dr. Meersch-Dini will discuss the results of the HandiCAP trial (Impact of Handover of Anesthesia Care on Adverse Postoperative Outcomes), a parallel-group, randomized clinical trial of intraoperative handover of anesthesia care in 12 centers in Germany.

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September 21, 2022: In PCT Grand Rounds, Birth Outcomes of a Nurse Home Visiting Program in a Medicaid-Eligible Population

Headshot of Dr. Margaret McConnell
Dr. Margarat McConnell

In this Friday’s PCT Grand Rounds, Dr. Margaret McConnell of the Harvard T.H. Chan School of Public Health will present “Effect of an Intensive Nurse Home Visiting Program on Adverse Birth Outcomes in a Medicaid-Eligible Population.” The Grand Rounds session will be held on Friday, September 23, 2022, at 1:00 pm eastern.

Dr. McConnell is an associate professor of global health economics at the Harvard Chan School. Her research uses experimental methods and impact evaluation strategies to answer questions about how to improve health outcomes for marginalized populations.

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September 14, 2022: PCT Grands Rounds Will Explore Feasibility of National Registry-Based Pragmatic Trials

Headshot of Dr. Tor Biering-Sørensen
Dr. Tor Biering-Sørensen

In this Friday’s PCT Grand Rounds, Dr. Tor Biering-Sørensen of the University of Copenhagen will present “Using Nationwide Registries to Conduct Pragmatic Randomized Trials: The DANFLU Program.” The Grand Rounds session will be held on Friday, September 16, 2022, at 1:00 pm eastern.

Dr. Biering-Sørensen is professor and head of the Center for Translational Cardiology and Pragmatic Randomized Trials at the University of Copenhagen and head of the Cardiovascular Non-Invasive Imaging Research Laboratory at Copenhagen University Hospital – Herlev and Gentofte.

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September 7, 2022: This Week’s Grand Rounds Kicks Off Special Series on Ethical and Regulatory Issues in Pragmatic Trials

Steven Joffe, MD, MPH
Dr. Steven Joffe

In this Friday’s PCT Grand Rounds, Dr. Steve Joffe will kick off our special Grand Rounds series, Ethical & Regulatory Dimensions of Pragmatic Clinical Trials, with a keynote presentation, “Building an Academic Learning Health System: Why Is It So Hard?” The Grand Rounds session will be held on Friday, September 9, 2022, at 1:00 pm eastern.

Dr. Joffe is a pediatric oncologist and bioethicist who is currently the Art and Ilene Penn Professor of Medical Ethics & Health Policy and Professor of Pediatrics at the University of Pennsylvania Perelman School of Medicine.

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This special Grand Rounds series will include an additional 5 moderated webinar discussions with panels of experts. The sessions will focus on a range of topics, including responding to signals of mental and behavioral health risk in pragmatic trials; the ethics of data sharing; ethical and regulatory considerations in the design and conduct of pragmatic trials; pragmatic research involving patients with dementia; and the use of waivers and alterations of consent. Read the full program.

August 29, 2022: Special Grand Rounds Series on Ethics in Pragmatic Trials Begins September 9th

Steven Joffe, MD, MPH
Dr. Steven Joffe will give a keynote presentation on September 9th.

The NIH Pragmatic Trials Collaboratory is launching a special Grand Rounds series to examine ethical and regulatory challenges in pragmatic clinical trials. Over the past decade, the program’s Ethics and Regulatory Core has worked with investigators to navigate ethical and regulatory complexities associated with research conducted within healthcare systems. With this new Grand Rounds series, the Core is bringing together bioethicists, investigators, and regulatory experts to share lessons learned, discuss empirical findings, and explore remaining uncertainties.

The webinar series, Ethical and Regulatory Dimensions of Pragmatic Clinical Trials, will kick off on Friday, September 9, at 1:00 pm ET with a keynote presentation by Dr. Steven Joffe, chair of the Department of Medical Ethics and Health Policy in the Perelman School of Medicine at the University of Pennsylvania.

The series will include an additional 5 moderated webinar discussions with panels of experts. The sessions will focus on a range of topics, including responding to signals of mental and behavioral health risk in pragmatic trials; the ethics of data sharing; ethical and regulatory considerations in the design and conduct of pragmatic trials; pragmatic research involving patients with dementia; and the use of waivers and alterations of consent.

Download the Ethical and Regulatory Dimensions of Pragmatic Trials series flyer and see the full schedule below.

All session are free and open to the public; no registration is required. Recordings will be archived on the Grand Rounds website.

August 24, 2022: Diuretic Comparison Project, a Point-of-Care Clinical Trial, to Be Featured in PCT Grand Rounds

Head shot of Dr. Areef IshaniIn this Friday’s PCT Grand Rounds, Dr. Areef Ishani of the University of Minnesota will present “The Diuretic Comparison Project: A Large Pragmatic Clinical Trial.” The Grand Rounds session will be held on Friday, August 26, 2022, at 1:00 pm eastern.

The Diuretic Comparison Project is a large, national “point-of-care clinical trial” comparing the effects of 2 thiazide-type diuretics, hydrochlorothiazide and chlorthalidone, on cardiovascular outcomes in older veterans with hypertension. The study is funded by the US Department of Veterans Affairs Cooperative Studies Program.

A point-of-care trial is an operational approach to the conduct of clinical trials—whether explanatory or pragmatic—that “centers on enhancing key clinical trial operations (including patient screening, consent, randomization, and data collection) and incorporating clinical trial processes into routine care to make clinical trials more accessible to broader and more diverse populations” (Propes et al 2022).

Dr. Ishani is the director of the Minneapolis Primary Care and Specialty Care Integrated Care Community at the Minneapolis VA, director of the VA Midwest Health Care Network, and a professor of medicine at the University of Minnesota.

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August 17, 2022: Making Lasting Change in Clinical Trial Inclusion and Diversity to Be Focus of PCT Grand Rounds

Head shots of Dr. Gerald Bloomfield and Dr. Michelle KelseyIn this Friday’s PCT Grand Rounds, Dr. Gerald Bloomfield and Dr. Michelle Kelsey will present “Inclusion and Diversity in Clinical Trials: Actionable Steps to Drive Lasting Change.” The Grand Rounds session will be held on Friday, August 19, 2022, at 1:00 pm eastern.

Dr. Bloomfield is an associate professor of medicine and global health and Dr. Kelsey is an assistant professor of medicine at Duke University.

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