December 28, 2022: NCHR public comments on FDA’s proposed rule supports a single IRB for all U.S. centers in multi-center clinical trials and greater diversity among IRB members. We urge the FDA to require more explicit improvements to address known weaknesses in oral and written informed consent procedures and address demographic differences in efficacy and safety of treatments studied clinical trials.
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Patient, Consumer, and Public Health Coalition Letter to Senate HELP and Energy and Commerce Committee Regarding User Fee Reauthorization Legislation
July 12, 2022: We write to urge you to expeditiously consolidate the two pieces of legislation to reauthorize the Food and Drug Administration (FDA) user fee programs for medical products. We request your consideration on reform to the accelerated approval pathway, clinical trial diversity, and new oversight of dietary supplements, cosmetics, and lab-developed diagnostic tests.
Read More »NCHR Comments on Recommended Diversity Plan to Improve Enrollment of Racial and Ethnic Minorities in Clinical Trials
June 13, 2022. We strongly support FDA’s proposed recommendations which provide specific, actionable guidance for sponsors to develop a meaningful Race and Ethnicity Diversity Plan. For too long, clinically meaningful disparities in the efficacy of drugs or therapies in minority populations have been hidden by a lack of data. However, this draft proposal should go further by providing meaningful incentives for sponsors to follow the recommendations.
Read More »When it comes to clinical trials, healthcare’s diversity problem is standing in the way of medical advancement
Fortune, November 5, 2021: The lack of diversity in clinical trials is standing in the way of medical advancement. NCHR president Dr. Diana Zuckerman explains how that delayed progress in treating triple negative breast cancer, which is more common among Black women.
Read More »Testimony of Dr. Diana Zuckerman, NCHR, at the FDA MDUFA Meeting
September 30, 2021: Dr. Diana Zuckerman testifies to the FDA regarding the lack of diversity and inclusion in medical device trials pointing out that most medical companies do not adequately study safety and effectiveness in women, older patients, and people of color.
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