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Surrogate end points in oncology: aligning drug development incentives and patient needs

Nature Reviews Clinical Oncology volume 22, pages 617–618 (2025)Cite this article

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In a provocative News & Views article (Prasad, V. Surrogate end points in oncology: the speed–uncertainty trade-off from the patients’ perspective. Nat. Rev. Clin. Oncol. 22, 313–314 (2025))1, Vinay Prasad reviews patient survey data indicating a willingness to wait 16 months to obtain moderate certainty of a drug’s efficacy and 22 months for high certainty. On the basis of these results, he advocates for moving away from surrogate end points, such as progression-free survival (PFS), to place greater emphasis on late-line treatments and incentivize the development of fewer anticancer drugs, in the hope that “truly transformative drugs” would still be developed and only “the most marginal drugs” would be abandoned1. Although we share the goal of maximizing the development of transformative medicines, the approach Prasad proposes might do more harm than good.

First, point estimates from discrete choice surveys do not fully capture the limited options and highly heterogeneous preferences of real-world patients. Prasad critiques the design of the PERSEUS trial for enrolling all patients with newly diagnosed multiple myeloma instead of only the highest risk subgroup, but the thousands of patients who could benefit from the broader inclusion criteria might disagree — and that is the point. Patients deserve the freedom to choose from a set of treatment options that has not been artificially reduced as a policy preference rather than on the basis of evidence. For some patients, waiting an additional 11–22 months for a new drug to be approved would mean never accessing that treatment within their remaining lifetime.

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Authors and Affiliations

  1. John F. Kennedy School of Government, Harvard University, Cambridge, MA, USA

    Matthew Vogel

  2. Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA

    Rona Yaeger

  3. Division of Medical Oncology, University of Ottawa, Ottawa, Ontario, Canada

    David J. Stewart

  4. Early Phase Drug Development Program, Sarah Cannon Research Institute, Nashville, TN, USA

    Vivek Subbiah

  5. Department of Biology, Tufts University, Medford, MA, USA

    Frank S. David

  6. Pharmagellan LLC, Milton, MA, USA

    Frank S. David

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  1. Matthew Vogel
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  2. Rona Yaeger
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  3. David J. Stewart
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  4. Vivek Subbiah
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Correspondence to Matthew Vogel.

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Competing interests

No funders were involved in the preparation of this piece. The content is solely the responsibility of the authors and does not necessarily represent the official views of their institutions. R.Y. has acted as an advisor for Amgen, Erasca, Loxo@Lilly, Merck, Mirati Therapeutics and Revolution Medicines; has received honoraria as a speaker from Zai Lab; and has received research support to her institution from Boehringer Ingelheim, Boundless Bio, Daiichi Sankyo, Mirati Therapeutics, Parabilis, Pfizer and Revolution Medicines. D.J.S. has received honoraria as a consultant or advisor from Abbvie, AstraZeneca and Merck; has 3% ownership in US Patent no. 9.675.663 (a test to predict response to TUSC2/FUS1 gene therapy); receives book royalties; and works in an institution that receives research support from a broad range of pharmaceutical companies. V.S. receives research funding for clinical trials through his institution from Abbvie, Agensys, Alfasigma, Altum, Amgen, Bayer, BERG Health, Blueprint Medicine, Boston Biomedical, Boston Pharmaceuticals, D3 Bio, Dragonfly Therapeutics, Exelixis, Fujifilm, GlaxoSmithKline, Idera Pharmaceuticals, Incyte, Inhibrix, Loxo@Lilly, MedImmune, NanoCarrier, Novartis, PharmaMar, Pfizer, Relay Therapeutics, Roche–Genentech, Takeda, Turning Point Therapeutics, and Vegenics; has had paid consulting and/or advisory roles paid to his institution from Abbvie, Astex Pharmaceuticals, AstraZeneca, Bayer, Endeavor Biomedicines, Genmab, Incyte, LabGenius therapeutics, Loxo@Lilly, Novartis, Obsidian Therapeutics, Pfizer, Pheon Therapeutics, Regeneron, Relay Therapeutics, Revolution Medicines and Roche/Genentech; and has had other consulting, advisory and/or continuing medical education-related roles for Bayer, Clinical Care Communications, Daiichi Sankyo, Helsinn Healthcare, Illumina, Incyte, Jazz Pharmaceuticals, Loxo@Lilly, Med Learning Group, Medscape, Novartis, OncLive, PERS and Relay Therapeutics. F.S.D. owns the consulting firm Pharmagellan and receives advisory fees from its biopharmaceutical clients. M.V. declares no competing interests.

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Vogel, M., Yaeger, R., Stewart, D.J. et al. Surrogate end points in oncology: aligning drug development incentives and patient needs. Nat Rev Clin Oncol 22, 617–618 (2025). https://doi.org/10.1038/s41571-025-01031-z

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