Skip to main content

Thank you for visiting nature.com. You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript.

The FDA’s latest move to expand eligibility for oncology trials — a double-edged sword?

Recent FDA draft guidance for sponsors of oncology clinical trials encourages enrolment of patients with incurable cancer and no potential for prolonged and/or near-normal survival, regardless of whether they have received existing treatment options. This guidance constitutes a substantial departure from current standards, with potentially profound implications for trial participants as well as drug regulation and reimbursement.

This is a preview of subscription content

Access options

Rent or Buy article

Get time limited or full article access on ReadCube.

from$8.99

All prices are NET prices.

References

  1. 1.

    US Food & Drug Administration. FDA In Brief: FDA Encourages Inclusion of Patients with Incurable Cancers in Oncology Clinical Trials Regardless of Prior Therapies. FDA https://www.fda.gov/news-events/press-announcements/fda-brief-fda-encourages-inclusion-patients-incurable-cancers-oncology-clinical-trials-regardless (2021).

  2. 2.

    Tao, D. L., Kartika, T., Tran, A. & Prasad, V. Phase I trials and therapeutic intent in the age of precision oncology: what is a patient’s chance of response? Eur. J. Cancer 139, 20–26 (2020).

    Article  Google Scholar 

  3. 3.

    Stensland, K. D. et al. Adult cancer clinical trials that fail to complete: an epidemic? J. Natl Cancer Inst. 106, dju229 (2014).

    Article  Google Scholar 

  4. 4.

    US Food & Drug Administration. Oncology Center of Excellence Guidance Documents. FDA https://www.fda.gov/about-fda/oncology-center-excellence/oncology-center-excellence-guidance-documents (2021).

  5. 5.

    Abola, M. V. & Prasad, V. The use of superlatives in cancer research. JAMA Oncol. 2, 139–141 (2016).

    Article  Google Scholar 

  6. 6.

    Swain, S. M. et al. Pertuzumab, trastuzumab and docetaxel in HER2-positive metastatic breast cancer. N. Engl. J. Med. 372, 724–734 (2015).

    CAS  Article  Google Scholar 

  7. 7.

    Kim, M. S. & Prasad, V. New drugs and options can enhance patient outcomes: but can they also erode them? Eur. J. Cancer 154, 1–3 (2021).

    CAS  Article  Google Scholar 

  8. 8.

    Chino, F. & Zafar, S. Y. Financial toxicity and equitable access to clinical trials. Am. Soc. Clin. Oncol. Educ. Book 39, 11–18 (2019).

    Article  Google Scholar 

  9. 9.

    Powell, K., Lythgoe, M. P. & Prasad, V. The Oncologic Drugs Advisory Committee votes of April 2021 — implications for the fate of Accelerated Approval. JAMA Oncol. https://doi.org/10.1001/JAMAONCOL.2021.3046 (2021).

    Article  PubMed  Google Scholar 

  10. 10.

    The RECOVERY Collaborative Group. Dexamethasone in hospitalized patients with Covid-19. N. Engl. J. Med. 384, 693–704 (2021).

    Article  Google Scholar 

Download references

Author information

Affiliations

Authors

Corresponding author

Correspondence to Vinay Prasad.

Ethics declarations

Competing interests

V.P. has received research funding from Arnold Ventures, royalties from the Johns Hopkins Press, Speaker’s fees from Evicore, and honoraria from Medscape and from various universities, medical centres, non-profit organizations and professional societies. V.P. has also acted as a consultant of UnitedHealthcare, and his Plenary Session podcast has Patreon backers. M.P.L. declares no competing interests.

Rights and permissions

Reprints and Permissions

About this article

Verify currency and authenticity via CrossMark

Cite this article

Lythgoe, M.P., Prasad, V. The FDA’s latest move to expand eligibility for oncology trials — a double-edged sword?. Nat Rev Clin Oncol 18, 745–746 (2021). https://doi.org/10.1038/s41571-021-00559-0

Download citation

Search

Quick links

Nature Briefing

Sign up for the Nature Briefing newsletter — what matters in science, free to your inbox daily.

Get the most important science stories of the day, free in your inbox. Sign up for Nature Briefing