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Registration trials in countries without access to US standards of care — pitfalls of interpretation

Nature Reviews Clinical Oncology volume 18, pages 395–396 (2021)Cite this article

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Data from several trials support the efficacy of first-line tyrosine-kinase inhibitors combined with immune-checkpoint inhibitors (ICIs) in metastatic renal cell carcinoma. However, whether combining these drugs is preferable to using them sequentially remains unclear. Here, we assess the implications for patients and payers of limited access to second-line ICIs in the control arms of trials.

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Authors and Affiliations

  1. Veterans Affairs Center for Clinical Management and Research, University of Michigan, Ann Arbor, MI, USA

    Garth W. Strohbehn

  2. Rogel Comprehensive Cancer Center, University of Michigan, Ann Arbor, MI, USA

    Garth W. Strohbehn

  3. Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel

    Daniel A. Goldstein

  4. Davidoff Cancer Center, Rabin Medical Center, Petach Tikvah, Israel

    Daniel A. Goldstein

  5. Clalit Health Services, Tel Aviv, Israel

    Daniel A. Goldstein

Authors
  1. Garth W. Strohbehn
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  2. Daniel A. Goldstein
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Corresponding author

Correspondence to Daniel A. Goldstein.

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Competing interests

D.A.G. has received institutional research funding from Bristol–Myers Squibb, Jannsen and Merck, has received consultancy fees from VIVIO Health and owns shares in VIVIO Health and TailorMed. G.W.S. is employed by the United States government; the views expressed are those of the authors alone and do not necessarily represent those of the Department of Veterans Affairs or the US Government.

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Strohbehn, G.W., Goldstein, D.A. Registration trials in countries without access to US standards of care — pitfalls of interpretation. Nat Rev Clin Oncol 18, 395–396 (2021). https://doi.org/10.1038/s41571-021-00506-z

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