Remove tag barrier-participation
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Grand Rounds February 23, 2024: Virtual Vigilance: Monitoring of Decentralized Clinical Trials (Adrian Hernandez, MD; Christopher J. Lindsell, PhD)

Rethinking Clinical Trials

There are 5 guiding principles for defining quality that should inform DCTs: Have we enrolled the right participants according to the protocol with adequate consent? Did participants receive the assigned treatment and did they stay on the treatment? What we often do not think about is verifying the identity of the participant.

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Grand Rounds December 15, 2023: Diversifying Clinical Trials: A Path Forward (Roxana Mehran, MD, FACC, FAHA, MSCAI, FESC)

Rethinking Clinical Trials

First, increasing diversity among trial participants must be a top priority in order to address health disparities and allow for optimal diagnosis and management of CVD in all. Increasing diversity in trial leadership is one of the most important strategies to increase diversity among RCT participants.

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Grand Rounds Ethics and Regulatory Series January 13, 2023: Ethical Considerations When Vulnerable Populations are Subjects in Pragmatic Trials (Emily A. Largent, JD, PhD, RN)

Rethinking Clinical Trials

But this might obscure heterogeneity within groups, intersecting sources of vulnerability, and other vulnerable participants, such as people with dementia. One definition of vulnerability is “an identifiably increased likelihood of incurring additional or greater wrongs,” as a result of research participation. it can be a barrier.

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Grand Rounds July 14, 2023: Lessons From the COORDINATE-Diabetes Trial (Christopher B. Granger, MD; Neha J. Pagidipati, MD, MPH)

Rethinking Clinical Trials

in which participants had type 2 diabetes mellitus and ASCVD. The intervention included assessment of local practices and barriers, development of strategies to overcome those barriers, and audit and feedback of quality metrics, with the goal of improving the way clinics approach treatment of these diseases. Granger, MD; Neha J.

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Grand Rounds August 19, 2022: Inclusion and Diversity in Clinical Trials: Actionable Steps to Drive Lasting Change (Gerald Bloomfield, MD, MPH; Michelle Kelsey, MD)

Rethinking Clinical Trials

There is a national priority to increase diversity in clinical trials, from regulatory, funding agencies, industry, and others, so that the participant population reflects the U.S. population at large, which is steadily becoming more diverse. It was held virtually on April 28-29, 2021. Learn more. pctGR, @Collaboratory1.

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Grand Rounds September 29, 2023: Navigating the Use of Patient-Reported Outcomes in Research and Practice: The PROTEUS Consortium (Claire Snyder, PhD; Norah Crossnohere, PhD; Anne Schuster, PhD)

Rethinking Clinical Trials

There are more than 50 organizations with participating in PROTEUS, including clinicians and patient advocates, research and methods organizations, clinical trials groups, funding and government agencies, and universities and health systems. The Advisory Group identified 47 different potential solutions to address the top barriers.

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Grand Rounds December 2, 2022: A Randomized Controlled Trial of Mobile Health Intervention in Heart Failure and Diabetes: Lessons Learned (G. Michael Felker, MD, MHS)

Rethinking Clinical Trials

Medication adherence can be a barrier to effectiveness. There was 1:1 randomization of participants to either the mHealth intervention or usual care. Can you talk about the compensation of participants? – Was it easier or harder than expected to recruit participants? Discussion Themes. One pays more than another.

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