January 24, 2023: A new report finds that 3,627 American children participated in clinical trials whose results remain hidden. This is not ‘only’ unethical – it’s illegal.
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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 »NCHR’s Testimony to FDA on End of Induction Response in High-Risk Neuroblastoma
May 12, 2022. Clinical benefits should remain the key endpoints for approval decisions of these treatments. Surrogate endpoints that predict clinical benefits are not yet established and until they are, we are concerned about their use as secondary endpoints unless the primary endpoint is also met.
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 »NCHR Statement Regarding Cancer Drugs that Failed to Confirm Efficacy after Accelerated Approval
April 29, 2021: Patients are being harmed when the FDA does not follow the law pertaining to FDA approval. Drugs must be proven safe and effective, and companies must continue randomized clinical trials that prove the benefits of their drugs outweigh the risks for most patients.
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