Skip to main content

Advertisement

SpringerLink
Log in

Quantifying Patient Subpopulation Disparities in New Drugs and Biologics Approved Between 2007 and 2017

  • Original Research
  • Published:
Therapeutic Innovation & Regulatory Science Aims and scope Submit manuscript

Abstract

Background

Tufts CSDD conducted a study to quantify the magnitude of participant subgroup demographic disparities in industry-funded pivotal trials and establish baseline participant diversity measures.

Methods

Eleven years of data on pivotal trials of all novel drugs and biologics approved between 2007 and 2017 (n = 341 drugs and n = 757 pivotal trials) was compiled and analyzed.

Results

The availability of reported participant demographic subgroup data was poor—most notably participant ethnicity with 63% of pivotal trials supporting all approved treatments missing data. The availability of data on participant race and ethnicity did not improve between 2007 and 2017. Participants of Black or of African Descent were the subgroup most highly under-represented. Three times as many participants in this demographic subgroup should have been enrolled in pivotal trials to achieve representation as dictated by disease prevalence rates and population census figures. Although variation was observed between disease conditions, under-representation of Black/African Descent participants occurred in nearly all conditions. Participants from indigenous communities were also highly under-represented. Asian participants were highly over-represented in pivotal trials. Approximately 14% more Hispanic/Latinx participants should have been enrolled in clinical trials to achieve population-proportional representation.

Conclusions

The results suggest that participant demographic disclosure practices are falling short and that insufficient diversity in clinical trials is limiting the value of guidance on medical treatment dosing and response. The study findings supplement the FDA’s Drug Trial Snapshot Reports and offer insight into the magnitude of, and trends in, participant demographic subgroup disparities.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. King TE. Racial disparities in clinical trials. N Eng J Med. 2002;346(18):1400–2.

    Article  Google Scholar 

  2. Ford M, Siminoff L, Pickelsimer E, Mainous A, et al. Unequal burden of disease, unequal participation in clinical trials: Solutions from African American and Latino community members. Health Soc Work. 2013;38(1):29–38.

    Article  Google Scholar 

  3. Luebbert R, Perez A. Barriers to clinical research participation among African Americans. J Trans Nurs. 2016;27(5):456–63.

    Article  Google Scholar 

  4. Oh S, Galanter J, Thakur N, et al. Diversity in clinical and biomedical research: a promise yet to be fulfilled. PLoS Med. 2015;12(12):e1001918.

    Article  Google Scholar 

  5. Pinsky PF, Ford M, Gamito E, et al. Enrollment of racial and ethnic minorities in the prostate, lung, colorectal and ovarian cancer screening trial. J Nat Med Assoc. 2008;100(3):291–8.

    Google Scholar 

  6. Gadegbeku C, Stillman K, Huffman P, et al. Factors associated with the enrollment of African Americans into a clinical trial: results from a study of kidney disease and hypertension. Cont Clin Trials. 2008;29:837–42.

    Article  Google Scholar 

  7. Gifford A, Cunningham W, Heslin K, et al. Participation in research and access to experimental treatments by HIV-infected patients. N Engl J Med. 2002;346(1):373–82.

    Google Scholar 

  8. Zuckerman R, Getz K, Kaitin K. A new mechanism for tracking publicly available study volunteer demographics. Drug Inf J. 2010;45:53–62.

    Google Scholar 

  9. Knepper T, McLeod H. When will clinical trials finally reflect diversity? Nature. 2018;557:157–9.

    Article  CAS  Google Scholar 

  10. Hamburg M. FDA action plan to enhance the collection and availability of demographic subgroup data. FDA report, Aug 2014, pp 1–2.

  11. Woodcock J, Anagnostiadis E, Loli M. 2018 Drug Trial Snapshots Summary Report. Silver Spring: Food and Drug Administration; 2019. https://www.fda.gov/media/120253/download. Accessed 23 Dec 2019.

  12. Woodcock J, Whyte J, Henderson M. 2015-2016 Global Participation in Clinical Trials Report. Silver Spring: Food and Drug Administration; 2017. https://www.fda.gov/media/106725/download. Accessed 23 Dec 2019.

  13. Diaz C. Increasing Diversity in Clinical Trials. Best Practices. Bethesda: Health Disparity Symposium; 2003.

    Google Scholar 

  14. Getz K, Faden L. Racial disparities among clinical research investigators. Am J Ther. 2008;15(1):3–11.

    Article  Google Scholar 

  15. Marks R, Jones H. Collecting and Tabulating Ethnicity and Race in the 2020 US Census. Washington, DC: US Census Bureau. https://www2.census.gov/about/training-workshops/2020/2020-02-19-pop-presentation.pdf. Accessed 11 May 2020.

  16. Salmon A, Nguyen C, Lee Y, Cooksey-James T. A review of barriers to minorities participation in cancer clinical trials: implications future cancer research. J Immigr Min Health. 2016;18:447–53.

    Article  Google Scholar 

  17. Wendler D, Kingston R, Madans J, et al. Are racial and ethnic minorities less willing to participate in health research? PLoS Med. 2006;3(2):201–10.

    Google Scholar 

  18. Getz K. Reflections on the evolution of patient engagement in drug development. Pharmaceut Med. 2019;33(3):179–85.

    PubMed  Google Scholar 

  19. Kim E, Bruinooge S, Roberts S, Ison G, et al. Broadening eligibility criteria to make clinical trials more representative: American Society of Clinical Oncology and Friends of Cancer Research joint research statement. J Clin Oncol. 2017;35(33):3737–44.

    Article  CAS  Google Scholar 

  20. Food and Drug Administration. Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry. Draft guidance document, June 2019. https://www.regulations.gov/docket?D=FDA-2019-D-1264. Accessed 9 Jan 2020.

Download references

Acknowledgements

This study was supported in part by a research grant from The Investigator-Initiated Studies Program of Merck Sharp & Dohme Corp. The opinions expressed in the paper are those of the authors and do not necessarily represent those of Merck Sharp & Dohme Corp.

Author information

Authors and Affiliations

  1. Tufts Center for the Study of Drug Development, Tufts University School of Medicine, Boston, MA, USA

    Kenneth A. Getz MBA, Zachary P. Smith MA & Yaritza Peña BA

  2. Tufts Center for the Study of Drug Development, Tufts University School of Medicine, 75 Kneeland Street, Suite 1100, Boston, MA, 02111, USA

    Kenneth A. Getz MBA

Authors
  1. Kenneth A. Getz MBA
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Zachary P. Smith MA
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Yaritza Peña BA
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Kenneth A. Getz MBA.

Ethics declarations

Conflict of interest

The authors have ‘no conflicts of interest.’

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Getz, K.A., Smith, Z.P. & Peña, Y. Quantifying Patient Subpopulation Disparities in New Drugs and Biologics Approved Between 2007 and 2017. Ther Innov Regul Sci 54, 1541–1550 (2020). https://doi.org/10.1007/s43441-020-00181-9

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s43441-020-00181-9

Keywords

Search

Navigation