Analysis of Serious Adverse Event Reporting for Patients Enrolled in Cancer Clinical Trials During the COVID-19 Pandemic

Accepted for Publication: August 12, 2022.

Published Online: October 27, 2022. doi:10.1001/jamaoncol.2022.4919

Corresponding Author: Meera V. Ragavan, MD, MPH, Division of Hematology and Oncology, Department of Medicine, University of California, 505 Parnassus Ave, M1286, San Francisco, CA 94143 (Meera.ragavan@ucsf.edu).

Author Contributions: Drs Ragavan and Borno had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Ragavan, Hong, Small, Borno.

Acquisition, analysis, or interpretation of data: Ragavan, Legaspi, Lalanne, Hong, Borno.

Drafting of the manuscript: Ragavan, Legaspi, Hong, Borno.

Critical revision of the manuscript for important intellectual content: Lalanne, Hong, Small, Borno.

Statistical analysis: Ragavan, Hong, Borno.

Administrative, technical, or material support: Lalanne, Borno.

Supervision: Hong, Small, Borno.

Conflict of Interest Disclosures: Dr Hong reported receiving career development awards from the American Society of Clinical Oncology Conquer Cancer Foundation and the American Society for Radiation Oncology/Prostate Cancer Foundation; grants from the American Cancer Society, Radiation Oncology Institute, and F. Hoffmann-La Roche outside the submitted work; and holding a patent for systems and methods for predicting acute care visits during outpatient cancer therapy. Dr Small reported receiving emergency COVID-19 funding from the University of California Research Grants Program Office; owning stock in, consulting for, and serving on the advisory board for Fortis Therapeutics; owning stock in Harpoon Medical; owning stock in, consulting for, and serving on the advisory board for Teon Therapeutics; consulting for, serving on the advisory board, and receiving honoraria for speaking from Janssen; receiving honoraria for speaking from Johnson & Johnson; and consulting for and serving on the advisory board for Ultragenyx during the conduct of the study and outside the submitted work. Dr Borno reported serving as the founder and chief executive officer of Trial Library outside the submitted work. No other disclosures were reported.

Additional Contributions: We thank Sylvia Zhang, BS, and Andrea Skafel, MSc, University of California, San Francisco Helen Diller Family Comprehensive Cancer Center, who contributed to the data collection for this study. They were not compensated for their contributions.