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

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

The COVID-19 pandemic affected cancer treatment in the context of usual care and clinical trials. Clinical trial activity and routine care were disrupted, allowing for limited new enrollments early in the pandemic.13 The proportion of remote visits and delayed nonessential surgeries or systemic therapies increased.4 Trials were prioritized based on disease severity and resource allocation.3

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CME Disclosure Statement: Unless noted, all individuals in control of content reported no relevant financial relationships. If applicable, all relevant financial relationships have been mitigated.

Article Information

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.

References
1.
Lorusso  D , Ray-Coquard  I , Oaknin  A , Banerjee  S .  Clinical research disruption in the post-COVID-19 era: will the pandemic lead to change?   ESMO Open. 2020;5(5):e000924. doi:10.1136/esmoopen-2020-000924 PubMedGoogle ScholarCrossref
2.
Pennell  NA , Dillmon  M , Levit  LA ,  et al.  American Society of Clinical Oncology Road to Recovery Report: learning from the COVID-19 experience to improve clinical research and cancer care.   J Clin Oncol. 2021;39(2):155-169. doi:10.1200/JCO.20.02953 PubMedGoogle ScholarCrossref
3.
Cinar  P , Bold  R , Bosslet  BA ,  et al.  Planning for post-pandemic cancer care delivery: recovery or opportunity for redesign?   CA Cancer J Clin. 2021;71(1):34-46. doi:10.3322/caac.21644 PubMedGoogle ScholarCrossref
4.
Powis  M , Milley-Daigle  C , Hack  S , Alibhai  S , Singh  S , Krzyzanowska  MK .  Impact of the early phase of the COVID pandemic on cancer treatment delivery and the quality of cancer care: a scoping review and conceptual model.   Int J Qual Health Care. 2021;33(2):mzab088. doi:10.1093/intqhc/mzab088PubMedGoogle ScholarCrossref
5.
Gerber  DE , Sheffield  TY , Beg  MS ,  et al.  Experience, perceptions, and recommendations concerning COVID-19-related clinical research adjustments.   J Natl Compr Canc Netw. 2020;19(5):505-512. doi:10.6004/jnccn.2020.7643 PubMedGoogle ScholarCrossref
6.
Knudsen  KE , Willman  C , Winn  R .  Optimizing the use of telemedicine in oncology care: postpandemic opportunities.   Clin Cancer Res. 2021;27(4):933-936. doi:10.1158/1078-0432.CCR-20-3758 PubMedGoogle ScholarCrossref
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