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Committing to the Inclusion of Diverse Populations in Clinical Research

Therapeutic Innovation & Regulatory Science volume 54, pages 922–924 (2020)Cite this article

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References

  1. Knepper TC, McLeod HL. When will clinical trials finally reflect diversity? Nature. 2018; 557:157–9. https://www.nature.com/articles/d41586-018-05049-5. Accessed 15 Aug 2019.

  2. Oh SS, Galanter J, Thakur N, et al. Diversity in clinical and biomedical research: a promise yet to be fulfilled. PLoS Med. 2015;12:e1001918. https://doi.org/10.1371/journal.pmed.1001918.

    Article  PubMed  PubMed Central  Google Scholar 

  3. Chen C, Wong R. Black Patients miss out on promising cancer drugs—ProPublica. 2018. https://www.propublica.org/article/black-patients-miss-out-on-promising-cancer-drugs. Accessed 2 July 2019.

  4. Clark LT, Watkins L, Piña IL, Elmer M, Akinboboye O, Gorham M, Jamerson B, McCullough C, Pierre C, Polis AB, Puckrein G. Increasing diversity in clinical trials: overcoming critical barriers. Curr Probl Cardiol. 2019;44(5):148–72. https://doi.org/10.1016/j.cpcardiol.2018.11.002.

    Article  PubMed  Google Scholar 

  5. Jones T, Madut D, Jackson L, Green CL, Thomas K. Abstract 136: Enrollment of black individuals in cardiovascular trials: a meta-analysis. Circulation. 2019. https://www.ahajournals.org/doi/abs/10.1161/hcq.12.suppl_1.136. Accessed 15 Oct 2019.

  6. Regnante JM, Richie NA, Fashoyin-Aje L, Vichnin M, Ford M, Roy UB, Turner K, Hall LL, Gonzalez E, Esnaola N, Clark LT. US Cancer Centers of excellence strategies for increased inclusion of racial and ethnic minorities in clinical trials. J Oncol Pract. 2019; 15(4):e289–99. https://ascopubs.org/doi/full/10.1200/JOP.18.00638. Accessed 15 Oct 2019.

  7. Congress US. National Institutes of Health revitalization act of 1993. Public Law. 1993:103–43. https://orwh.od.nih.gov/sites/orwh/files/docs/NIH-Revitalization-Act-1993.pdf. Accessed 15 Aug 2019.

  8. Food and Drug Administration Safety and Innovation Act of 2012. Public Law. 2012:112–144. https://www.govinfo.gov/content/pkg/PLAW-112publ144/pdf/PLAW-112publ144.pdf. Accessed 15 Aug 2019.

  9. FDA Reauthorization Act of 2017. Section 610(a) Public Law. 2017:115–52. https://www.congress.gov/115/plaws/publ52/PLAW-115publ52.pdf. Accessed 15 Oct 2019.

  10. FDA Guidance Document. Enhancing the diversity of clinical trial populations—eligibility criteria, enrollment practices, and trial designs guidance for industry. 2019. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enhancing-diversity-clinical-trial-populations-eligibility-criteria-enrollment-practices-and-trial. Accessed 15 Aug 2019.

  11. The Editors of the Lancet Group. The Lancet Groups commitments to gender equity and diversity. The Lancet. 2019;394:452–3. https://doi.org/10.1016/s0140-6736(19)31797-0.

    Article  CAS  Google Scholar 

  12. Kretser A, Murphy D, Dwyer J. Scientific integrity resource guide: efforts by federal agencies, foundations, nonprofit organizations, professional societies, and academia in the United States. Crit Rev Food Sci Nutr. 2017;57(1):163–80.

    Article  CAS  Google Scholar 

  13. National Academies of Sciences, Engineering, and Medicine. Fostering integrity in research. Washington DC: The National Academies Press; 2017.

    Google Scholar 

  14. Altman DG, Moher D. Declaration of transparency for each research article. BMJ. 2013;347:f4796. https://doi.org/10.1136/bmj.f4796.

    Article  PubMed  PubMed Central  Google Scholar 

  15. Loder E, Groves T. The BMJ requires data sharing on request for all trials. BMJ. 2015;350:h2373. https://doi.org/10.1136/bmj.h2373.

    Article  PubMed  Google Scholar 

  16. Walport M, Brest P. Sharing research data to improve public health. The Lancet. 2011;377(9765):537–9.

    Article  Google Scholar 

  17. PhRMA and EFPIA Principles for responsible clinical trial data sharing. https://www.phrma.org/-/media/Project/PhRMA/PhRMA-Org/PhRMA-Org/PDF/PhRMAPrinciplesForResponsibleClinicalTrialDataSharing.pdf. Accessed 19 Oct 2019.

  18. Miller J, Ross J, Wilenzick M, Mello M. Sharing of clinical trial data and results reporting practices among large pharmaceutical companies: cross sectional descriptive study and pilot of a tool to improve company practices. BMJ. 2019;366:14217. https://doi.org/10.1136/bmj.14217.

    Article  Google Scholar 

  19. PharmExec.Com. Pharm Exec’s Top 50 Companies. 2018. http://www.pharmexec.com/pharm-execs-top-50-companies-2018. Accessed 2 July 2019.

  20. GEN—Genetic Engineering and Biotechnology News. Top 50 NIH-Funded Institutions of 2018. https://www.genengnews.com/a-lists/top-50-nih-funded-institutions-of-2018/. Accessed 1 Feb 2019.

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Funding

There was no external funding for the work reflected in this manuscript.

Author information

Authors and Affiliations

  1. Multi-Regional Clinical Trials Center of the Brigham and Women’s Hospital and Harvard University, Boston, MA, USA

    Hayat R. Ahmed, David H. Strauss & Barbara E. Bierer

  2. Columbia University, New York, USA

    David H. Strauss

  3. Brigham and Women’s Hospital and Harvard Medical School, 75 Francis St, Boston, MA, 02115, USA

    Barbara E. Bierer

Authors
  1. Hayat R. Ahmed
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  2. David H. Strauss
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  3. Barbara E. Bierer
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Contributions

All authors contributed equally. The three authors have worked together seamlessly on this project from the outset. The idea was conceived by BEB and DHS. HRA collected the data from public websites for statements of commitments from academic medical centers and pharmaceutical companies reported here. The data were reviewed by BEB. HRA wrote the first draft of the manuscript that was significantly edited and finalized by DHS and BEB.

Corresponding author

Correspondence to Barbara E. Bierer.

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Ahmed, H.R., Strauss, D.H. & Bierer, B.E. Committing to the Inclusion of Diverse Populations in Clinical Research. Ther Innov Regul Sci 54, 922–924 (2020). https://doi.org/10.1007/s43441-019-00020-6

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  • DOI: https://doi.org/10.1007/s43441-019-00020-6

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