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Oncology

Association of the Coronavirus Disease 2019 (COVID-19) Outbreak With Enrollment in Cancer Clinical Trials

Educational Objective
To understand how COVID-19 affects enrollment in Cancer Clinical Trials

1 Credit CME

JAMA Network Open

Published Online: June 1, 2020

Research Letter

Article Information and Disclosures

Joseph M. Unger, PhD¹;

Charles D. Blanke, MD²;

Michael LeBlanc, PhD¹;

Dawn L. Hershman, MD³

Author Affiliations

¹SWOG Cancer Research Network Statistics and Data Management Center, Fred Hutchinson Cancer Research Center, Seattle, Washington
²SWOG Cancer Research Network Group Chair’s Office, Oregon Health and Science University Knight Cancer Institute, Portland
³Columbia University Medical Center, New York, New York

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Enrollment in clinical trials is key in advancing new treatments for patients with cancer. Poor accrual can result in trials that fail to complete or generate less timely research findings for patients in need of better therapies. The outbreak of coronavirus disease 2019 (COVID-19) has caused severe disruptions in care for many patients—especially patients with cancer, who are more susceptible to infections because of underlying malignant neoplasms or therapy—in an effort to reduce patient and staff exposure and to preserve resources. Given systemwide changes, some institutions in areas with high rates of COVID-19 have stopped all enrollment in interventional trials, while others have made minor changes. An important question is how the COVID-19 pandemic is associated with national enrollment in cancer clinical trials.

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Article Information

Accepted for Publication: May 4, 2020.

Published: June 1, 2020. doi:10.1001/jamanetworkopen.2020.10651

Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2020 Unger JM et al. JAMA Network Open.

Corresponding Author: Joseph M. Unger, PhD, SWOG Statistics and Data Management Center, Fred Hutchinson Cancer Research Center, 1100 Fairview Ave N, M3-C102, PO Box 19024, Seattle, WA 98109-1024 (junger@fredhutch.org).

Author Contributions: Dr Unger 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: Unger, Hershman.

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

Drafting of the manuscript: All authors.

Critical revision of the manuscript for important intellectual content: Unger, Blanke, Hershman.

Statistical analysis: Unger.

Obtained funding: Unger, Blanke.

Administrative, technical, or material support: Blanke, LeBlanc.

Supervision: Unger, Blanke.

Conflict of Interest Disclosures: Dr LeBlanc reported receiving grants from the National Institutes of Health outside the submitted work. No other disclosures were reported.

Funding/Support: Research reported in this article was supported in part by grant 5UG1CA189974 from the Division of Cancer Prevention, National Cancer Institute, National Institutes of Health (Drs Blanke and Hershman); grants U10CA180888 and U10CA180819 from the National Cancer Institute, National Institutes of Health (Drs Blanke and Leblanc, respectively); and in part by The Hope Foundation for Cancer Research in support of infrastructure, data analysis, and trial design within the SWOG Cancer Research Network, at the SWOG Statistics and Data management Center (Dr Unger).

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 recognize all the SWOG researchers and investigators on the front lines of patient care. In addition, the authors wish to thank SWOG staff members Cathy Rankin, MS, for development of coronavirus disease 2019–related data on SWOG trials and Dana Sparks, MAT, for overseeing SWOG protocol changes and memos related to coronavirus disease 2019. They were compensated for their time.

References

Dong E , Du H , Gardner L . An interactive web-based dashboard to track COVID-19 in real time. Lancet Infect Dis. 2020;20(5):533-534. doi:10.1016/S1473-3099(20)30120-1 PubMed Google Scholar Crossref

GitHub. Data from The New York Times based on reports from state and local health agencies. Accessed April 12, 2020. https://github.com/nytimes/covid-19-data

National Clinical Trial Network Group Chairs. NCTN Group Chairs: cancer trials take backseat to clinical care amid COVID-19 pandemic. The Cancer Letter. Published April 10, 2020. Accessed May 7, 2020. https://cancerletter.com/articles/20200410_1/

National Cancer Institute. Presentations from the 1st virtual joint meeting of NCI Board of Scientific Advisors and National Cancer Advisory Board. April 9, 2020. Accessed April 29, 2020. https://deainfo.nci.nih.gov/advisory/joint/0420/index.htm

US Food and Drug Administration. FDA guidance on conduct of clinical trials of medical products during COVID-19 pandemic. Published March 2020. Accessed April 9, 2020. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-pandemic

National Cancer Institute. Coronavirus guidance. Updated April 1, 2020. Accessed April 9, 2020. https://ctep.cancer.gov/investigatorResources/corona_virus_guidance.htm

AMA CME Accreditation Information

Credit Designation Statement: The American Medical Association designates this Journal-based CME activity activity for a maximum of 1.00  AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to:

1.00 Medical Knowledge MOC points in the American Board of Internal Medicine's (ABIM) Maintenance of Certification (MOC) program;;
1.00 Self-Assessment points in the American Board of Otolaryngology – Head and Neck Surgery’s (ABOHNS) Continuing Certification program;
1.00 MOC points in the American Board of Pediatrics’ (ABP) Maintenance of Certification (MOC) program;
1.00 Lifelong Learning points in the American Board of Pathology’s (ABPath) Continuing Certification program; and
1.00 CME points in the American Board of Surgery’s (ABS) Continuing Certification program

It is the CME activity provider's responsibility to submit participant completion information to ACCME for the purpose of granting MOC credit.