TAG ARCHIVES FOR diversity in clinical trials

3
Nov2020

Diversity in clinical trials comes to the fore

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3 Nov
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Amid both promising and worrying signs in the development of treatments and vaccines for COVID-19, and in the context of a considerable amount of scrutiny of medical research, some researchers, ethicists, and advocates are working to make sure science doesn’t lose sight of a critical issue: diversity in the clinical trial participant pool. The distribution of research benefits to participants—and the consideration of race in subject selection—is tightly woven into the Belmont Report and has been a mainstay in research ethics discussion ever since. But despite the decades-long consideration of race and ethnicity in clinical trials, many trials still don’t enroll populations that reflect the diversity of the general populace or the group affected by the condition being studied. Read more

11
Jun2020

AER19 Blog Squad: Overcoming Distrust in Our Research Population

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11 Jun
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When I started my research career back in 2004, I was working in the biggest trauma center in the Atlanta area, Grady Healthcare System. I had arrived in the country under a work visa to help with the Department of Orthopaedics' clinical trials. I remember the nervousness of speaking to potential study participants because I was not only new to clinical research, having only done chart review projects in the past, I was also new in America and America’s history of research with minorities. Now, after all these years working as a research coordinator and IRB professional, and living in the United States for more than 15 years, I know how important it is to rebuild trust and increase minority participation in research to ensure not only that we are doing quality studies, but also that we help in diminishing the social injustices our communities still undergo today. Read more

30
Jul2019

PRIM&R’s Response to FDA’s Draft Guidance on Enhancing the Diversity of Clinical Trial Populations

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30 Jul
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In June, the FDA issued a draft guidance, "Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs." The issuance of this guidance satisfies a mandate of the FDA Reauthorization Act of 2017 (FDARA), and builds on other recent efforts by the FDA to broaden eligibility criteria for clinical trials and avoid unnecessary exclusions. PRIM&R submitted comments on the guidance this week, and we wanted to share them with you and encourage you to consider submitting your own comments on this important topic—the FDA is accepting comments until August 6. Read more