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Association of the COVID-19 Outbreak With Patient Willingness to Enroll in Cancer Clinical Trials

Educational Objective
To identify the key insights or developments described in this article
1 Credit CME

The coronavirus disease 2019 (COVID-19) outbreak substantially reduced cancer clinical trial accrual.1 Many sites temporarily paused enrollment owing to state, local, sponsor, or institutional restrictions intended to prevent the spread of COVID-19.2 Once site and enrollment restrictions lift, it is unclear whether patients will be as willing to participate in clinical research as before the outbreak, especially if community COVID-19 transmission is still occurring. To examine this, we surveyed a large group of cancer survivors about their attitudes toward trial participation during the COVID-19 pandemic.

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Article Information

Accepted for Publication: September 3, 2020.

Published Online: November 12, 2020. doi:10.1001/jamaoncol.2020.5748

Open Access: This is an open access article distributed under the terms of the CC-BY-NC-ND License. © 2020 Fleury ME et al. JAMA Oncology.

Corresponding Author: Mark E. Fleury, PhD, American Cancer Society Cancer Action Network, 6605 13th Pl NW, Washington, DC 20012 (mark.fleury@cancer.org).

Author Contributions: Dr Fleury had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: All authors.

Acquisition, analysis, or interpretation of data: All authors.

Drafting of the manuscript: Fleury, Unger.

Critical revision of the manuscript for important intellectual content: All authors.

Statistical analysis: Unger, Farner.

Administrative, technical, or material support: Fleury.

Supervision: Fleury, Unger.

Conflict of Interest Disclosures: None reported.

Funding/Support: Funding for building the survey cohort and survey administration was provided by a grant from Bristol Myers Squibb. Additional funding support was provided by the Public Health Sciences Division of the Fred Hutchinson Cancer Research Center.

Role of the Funder/Sponsor: The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Additional Contributions: We wish to thank all of the patients and survivors who volunteered their time to complete the survey. Small incentive payment in the form of gift cards was offered for participating.

Additional Information: Ms Farner was employed by the American Cancer Society Cancer Action Network at the time the survey was conducted and the data were analyzed, but she is now affiliated with Josh Bersin Academy.

References
1.
Unger  JM , Blanke  CD , LeBlanc  M , Hershman  DL .  Association of the coronavirus disease 2019 (COVID-19) outbreak with enrollment in cancer clinical trials.   JAMA Netw Open. 2020;3(6):e2010651. doi:10.1001/jamanetworkopen.2020.10651PubMedGoogle Scholar
2.
Richards  M , Anderson  M , Carter  P , Ebert  BL , Mossialos  E .  The impact of the COVID-19 pandemic on cancer care.   Nat Cancer. 2020;1:1-3. doi:10.1038/s43018-020-0074-yPubMedGoogle ScholarCrossref
3.
American Cancer Society Cancer Action Network. COVID survey questions. Accessed October 8, 2020. https://www.fightcancer.org/sites/default/files/docs/resources/CT_COVID_Survey%20Quetions.pdf
4.
National Cancer Institute. Coronavirus guidance. Updated April 1, 2020. Accessed April 9, 2020. https://ctep.cancer.gov/investigatorResources/corona_virus_guidance.htm
5.
US Food and Drug Administration. FDA guidance on conduct of clinical trials of medical products during COVID-19 public health emergency. Updated September 21, 2020. Accessed October 8, 2020. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-pandemic
6.
Sharpless  NE .  COVID-19 and cancer.   Science. 2020;368(6497):1290. doi:10.1126/science.abd3377PubMedGoogle ScholarCrossref
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