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Article CommentaryCommentary

The FDA Initiative to Assure Racial and Ethnic Diversity in Clinical Trials

Eli Y. Adashi and I. Glenn Cohen
The Journal of the American Board of Family Medicine April 2023, 36 (2) 366-368; DOI: https://doi.org/10.3122/jabfm.2022.220290R1
Eli Y. Adashi
From the Professor of Medical Science, Former Dean of Medicine and Biological Sciences, Brown University, Providence, RI (EYA); Attwood and Leslie Williams Professor of Law, Harvard Law School, Faculty Director, Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard University, Cambridge, MA (IGC).
MD, MS
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I. Glenn Cohen
From the Professor of Medical Science, Former Dean of Medicine and Biological Sciences, Brown University, Providence, RI (EYA); Attwood and Leslie Williams Professor of Law, Harvard Law School, Faculty Director, Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard University, Cambridge, MA (IGC).
JD
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References

  1. 1.↵
    FDA Takes Important Steps to Increase Racial and Ethnic Diversity in Clinical Trials. April 132022; Available from: https://www.fda.gov/news-events/press-announcements/fda-takes-important-steps-increase-racial-and-ethnic-diversity-clinical-trials.
  2. 2.↵
    1. Scharff DP,
    2. Mathews KJ,
    3. Jackson P,
    4. Hoffsuemmer J,
    5. Martin E,
    6. Edwards D
    . More than Tuskegee: understanding mistrust about research participation. J Health Care Poor Underserved 2010; Aug 21:879–97. PMID: 20693733; PMCID: PMC4354806. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4354806/.
    OpenUrlPubMed
  3. 3.↵
    1. Bajaj SS,
    2. Stanford FC
    . Beyond Tuskegee — Vaccine distrust and everyday racism. N Engl J Med 2021;384:e12.:e12.
    OpenUrlCrossRef
  4. 4.↵
    Drug Trials Snapshots. Summary Report. February 2021. Available from: https://www.fda.gov/media/145718/download.
  5. 5.↵
    United States Census Bureau. 2020. Census illuminates racial and ethnic composition of the country. August 122021; Available from: https://www.census.gov/library/stories/2021/08/improved-race-ethnicity-measures-reveal-united-states-population-much-more-multiracial.html#:∼:text=Black%20or%20African%20American%20Population,-The%20Black%20or&text=In%202020%2C%20the%20Black%20or,million%20and%2012.6%25%20in%202010.
  6. 6.↵
    1. Turner BE,
    2. Steinberg JR,
    3. Weeks BT,
    4. Rodriguez F,
    5. Cullen MR
    . Race/ethnicity reporting and representation in US clinical trials: A cohort study. Lancet Reg Health Am 2022;11:(In Press). Available online 10 April 2022. 100252.
    OpenUrl
  7. 7.↵
    National Academies of Sciences, Engineering, and Medicine. 2022. Improving Representation in Clinical Trials and Research: Building Research Equity for Women and Underrepresented Groups. Washington, DC: The National Academies Press.
  8. 8.↵
    S.2706 - 117th Congress (2021–2022): DIVERSE Trials Act. (10 August 2021). Available from: https://www.congress.gov/bill/117th-congress/senate-bill/2706.
  9. 9.↵
    H.R.6584 - 117th Congress (2021–2022): DEPICT Act. (04 February 2022). Available from: https://www.congress.gov/bill/117th-congress/house-bill/6584.
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The Journal of the American Board of Family     Medicine: 36 (2)
The Journal of the American Board of Family Medicine
Vol. 36, Issue 2
March/April 2023
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The FDA Initiative to Assure Racial and Ethnic Diversity in Clinical Trials
Eli Y. Adashi, I. Glenn Cohen
The Journal of the American Board of Family Medicine Apr 2023, 36 (2) 366-368; DOI: 10.3122/jabfm.2022.220290R1

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The FDA Initiative to Assure Racial and Ethnic Diversity in Clinical Trials
Eli Y. Adashi, I. Glenn Cohen
The Journal of the American Board of Family Medicine Apr 2023, 36 (2) 366-368; DOI: 10.3122/jabfm.2022.220290R1
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Keywords

  • Clinical Trials
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