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Despite The FDA's Five-Year Plan, Black Patients Remain Inadequately Represented In Clinical Trials For Drugs

TitleDespite The FDA's Five-Year Plan, Black Patients Remain Inadequately Represented In Clinical Trials For Drugs
Publication TypeJournal Article
Year of Publication2022
AuthorsGreen AK, Trivedi N, Hsu JJ, Yu NL, Bach PB, Chimonas S
JournalHealth AffairsHealth Affairs
Type of ArticleArticle
ISBN Number02782715
Accession Number155792262
KeywordsAfrican American, Black people, clinical trials, Data analysis software, Descriptive statistics, Diversity in clinical trials, DRUG approval, HUMAN research subjects, Patient selection, United States. Food & Drug Administration
AbstractFor decades Black patients have been underrepresented in clinical trials of new treatments. In response, in 2015 the Food and Drug Administration (FDA) launched a five-year action plan aimed at improving diversity in and transparency of pivotal clinical trials for newly approved drugs. The plan contained many action steps that were aimed at improving the racial representativeness of clinical trials and enhancing the reporting of new drug side effects and benefits across diverse populations. Yet, relying on the FDA's Drug Trials Snapshots website, we failed to find evidence that the action plan improved representation of Black trial participants. Black patients remained inadequately represented in clinical trials for drugs, with a median of one-third the enrollment that would be required, whether the trials were started before, during, or after the action plan. Fewer than 20 percent of drugs had data regarding treatment benefits or side effects reported for Black patients; neither measure improved during the action plan period. [ABSTRACT FROM AUTHOR]
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