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Myths about diversity in clinical trials reduce return on investment for industry

Nature Medicine volume 28, pages 1520–1522 (2022)Cite this article

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To the Editor — Misconceptions in drug development often begin at the earliest stages. People enrolled in clinical trials are in general not representative of the population with medical need1, but the problem is particularly pernicious in early, first-in-human phase 1 studies. This is, in part, a result of stricter eligibility criteria in early studies, and is also due to clustering of phase 1 trial centers in urban locations that are less accessible to patients in rural or underserved areas. Efforts to enhance or mandate enrollment of a diverse population in phase 1 trials are often deferred, in the belief and expectation that later phase 2 and 3 studies can address this need. Yet limiting access to new therapies while they are being tested in phase 1 trials fails to promote inclusive research and is also ethically concerning. In an interview study of 100 adult patients with solid tumors, a significant majority believed that access to investigational new drugs is a fundamental right and yet is also too difficult, citing frequent ineligibility and time-consuming enrollment as barriers to entering these early-phase studies2.

Phase 1 studies provide key safety data, can detect preliminary signals of efficacy and, in an era of expedited programs, may even enable accelerated approval of new drugs. The benefits of recruiting patients to a phase 1 trial cannot be reconciled with the longstanding belief in industry that clinical trial participants from under-represented populations need to be included only in the later stages of drug development. The recent accelerated US Food and Drug Administration (FDA) approval of the antibody–drug conjugate sacituzumab govitecan (Trodelvy; Gilead) highlights the dilemma facing drug developers and regulators. Although Black women have mortality rates for triple-negative breast cancer that are 41% higher than those of non-Hispanic white women, FDA approval was based on a study of 108 patients in which only 7% were Black3. Ultimately, a subgroup analysis of the confirmatory phase 3 study revealed an equal clinical benefit for Black patients, but it would have been much better to address efficacy in this patient group at an earlier stage, to determine the true impact of the approval of this medication.

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References

  1. US Food and Drug Administration (FDA). Enhancing the Diversity of Clinical Trial Populations Eligibility Criteria, Enrollment Practices, and Trial Designs for Industry; https://www.fda.gov/media/127712/download (2019).

  2. Pentz, R. D. et al. IRB 29(4), 1–6 (2007).

    PubMed  Google Scholar 

  3. FDA. Drug Trial Snapshot: TRODELVY; https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trial-snapshot-trodelvy (2020).

  4. Jackson, L. A. et al. N. Engl. J. Med. 383, 1920–1931 (2020).

    Article  CAS  Google Scholar 

  5. Folegatti, P. M. et al. Lancet 396, 467–478 (2020).

    Article  CAS  Google Scholar 

  6. Shepherd, F. A. et al. N. Engl. J. Med. 353, 123–132 (2005).

    Article  CAS  Google Scholar 

  7. Lee, S. et al. JNCI Cancer Spectr. 5, pkab034 (2021).

    Article  Google Scholar 

  8. Liu, R. et al. Nature 592, 629–633 (2021).

    Article  CAS  Google Scholar 

  9. Salama, C. et al. N. Engl. J. Med. 384, 20–30 (2021).

    Article  CAS  Google Scholar 

  10. Rosas, I. O. & Hunter, S. et al. N. Engl. J. Med. 384, 1503–1516 (2021).

    Article  CAS  Google Scholar 

Download references

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Authors and Affiliations

  1. Oncology Early Clinical Development, Genentech, South San Francisco, CA, USA

    Mohammed Suhail Chaudhry & Jennifer Lauchle

  2. Oncology and Hematology Product Development, Genentech, South San Francisco, CA, USA

    Jessica Spahn & Charles S. Fuchs

  3. Health Equity and Inclusive Research, US Medical Affairs, Genentech, South San Francisco, USA

    Shilpen Patel

  4. Yale University, Yale Cancer Center, New Haven, CT, USA

    Charles S. Fuchs

  5. Scientific Operations and Evidence Generation, US Medical Affairs, Genentech, South San Francisco, CA, USA

    Nikheel Kolatkar

  6. Health Equity & Population Science, Genentech, South San Francisco, CA, USA

    Nicole Richie

  7. Chief Diversity Office, Genentech, South San Francisco, CA, USA

    Quita Highsmith & Meghan McKenzie

  8. Global Health Equity Strategy, Portfolio and Product Development, Genentech, South San Francisco, CA, USA

    Ruma Bhagat

Authors
  1. Mohammed Suhail Chaudhry
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Contributions

M.S.C., J.S., S.P. and R.B. conceptualized the manuscript. All authors drafted the manuscript. M.S.C. edited the manuscript.

Corresponding author

Correspondence to Mohammed Suhail Chaudhry.

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Competing interests

C.S.F. reports consulting roles for Amylin Pharmaceuticals, Astra-Zeneca, Bain Capital, CytomX Therapeutics, Daiichi-Sankyo, Eli Lilly, Entrinsic Health, Evolveimmune Therapeutics, Genentech, Merck and Taiho, served as a Director for CytomX Therapeutics, owns unexercised stock options for CytomX and Entrinsic Health, is a co-founder of Evolveimmune Therapeutics and has equity in this private company, and has provided expert testimony for Amylin Pharmaceuticals and Eli Lilly. All authors are employees of Roche Genentech and hold stock in Roche Genentech.

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Chaudhry, M.S., Spahn, J., Patel, S. et al. Myths about diversity in clinical trials reduce return on investment for industry. Nat Med 28, 1520–1522 (2022). https://doi.org/10.1038/s41591-022-01858-4

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