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Reply to ‘Correcting the ASCO position on phase I clinical trials in cancer’

Nature Reviews Clinical Oncology volume 17, pages 125–126 (2020)Cite this article

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I thank Dr. Burris for his letter. My article (Kimmelman, J. Phase I trials as therapeutic options: (usually) a betrayal of evidence-based medicine. Nat. Rev. Clin. Oncol. https://doi.org/10.1038/s41571-019-0264-7 (2019))1 concerns an ethical question: are oncologists and others justified in presenting phase I trial participation as a therapeutic option for patients meeting the eligibility criteria? My view is that, generally speaking, they are not. For as long as physicians do not yet know how to use a drug, much less whether it works under near-optimum conditions, presenting phase I trials as a therapeutic option betrays the spirit of evidence-based medicine. It also fails to alert clinicians to the fact that their patients are, in fact, making personal sacrifices in the name of medical advances.

Dr Burris suggests (Burris, H.A. Correcting the ASCO position on phase I clinical trials in cancer. Nat. Rev. Clin. Oncol. https://doi.org/10.1038/s41571-019-0311-4 (2019))2 that I confuse ASCO’s position (that phase I trials have ‘therapeutic intent’) with the position that phase I trials actually have ‘therapeutic benefit.’ Au contraire. My published response to ASCO’s phase I position statement makes clear that a declaration of ‘therapeutic intent’ has practically no bearing on the ethical question I am concerned with3. Intent is merely a mental state. Physicians who offer quack treatments such as caesium chloride outside of the context of a clinical trial might do so with therapeutic intent. This intent, however, does not justify recommending such treatments, much less asking patients to endure their disruptive effects. By contrast, claiming that something is therapeutic is a substantive claim about the relationship between the risks and benefits of a particular treatment in a specific population of patients. From reading ASCO’s and Dr Burris’s statements, it is nearly impossible to come away with the view that both regard phase I trials not merely as therapeutically intended, but substantively therapeutic.

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References

  1. Kimmelman, J. Phase I trials as therapeutic options: (usually) a betrayal of evidence-based medicine. Nat. Rev. Clin. Oncol. 16, 719–720 (2019).

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  2. Burris, H. A. Correcting the ASCO position on phase I clinical trials in cancer. Nat. Rev. Clin. Oncol. https://doi.org/10.1038/s41571-019-0311-4 (2019).

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  3. Kimmelman, J. Is participation in cancer phase I trials really therapeutic? J. Clin. Oncol. 35, 135–138 (2016).

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  4. Kimmelman, J. & Federico, C. Consider drug efficacy before first-in-human trials. Nature 542, 25–27 (2017).

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  5. National Cancer Institute.NCI Informed Consent Template. cancer.gov https://ctep.cancer.gov/protocolDevelopment/informed_consent.htm (2019).

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  1. Studies of Translation, Ethics and Medicine (STREAM), Biomedical Ethics Unit, McGill University, Montreal, Quebec, Canada

    Jonathan Kimmelman

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  1. Jonathan Kimmelman
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Correspondence to Jonathan Kimmelman.

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Kimmelman, J. Reply to ‘Correcting the ASCO position on phase I clinical trials in cancer’. Nat Rev Clin Oncol 17, 125–126 (2020). https://doi.org/10.1038/s41571-019-0312-3

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