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Rethinking Clinical Trials Reform During the COVID-19 Pandemic

Educational Objective
To understand how to reform clinical trials during COVID-19
1 Credit CME

Most of the 1.8 million US patients each year who are diagnosed as having cancer remain alive 5 years after diagnosis.1 This success can largely be attributed to clinical trials that have studied novel anticancer therapies in addition to advances in surgical techniques, radiotherapy, and supportive care. We have achieved this progress despite the fact that fewer than 10% of adult patients with cancer in the United States enroll in clinical trials.2 One can only imagine the magnitude of benefit that patients would experience if we improve and accelerate clinical trial enrollment. Many scholars have outlined barriers to participation in clinical trials and proposed strategies to overcome them, but despite these ideas, little progress has been made. A new, unforeseen barrier has been the emergence of severe acute respiratory syndrome coronavirus 2 causing the coronavirus disease 2019 (COVID-19) pandemic across the globe. While this pandemic has impeded and slowed clinical trial enrollments, we view this unfortunate event as an opportunity to reform the way we conduct clinical trials moving forward. Herein, we examine several changes precipitated by the current crisis that represent potential areas of improvement for the future.

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Article Information

Corresponding Author: Chadi Nabhan, MD, MBA, Caris life Sciences; 750 W John Carpenter Fwy, Ste 800, Irving, TX 75039 (cnabhan1968@gmail.com).

Published Online: August 6, 2020. doi:10.1001/jamaoncol.2020.3142

Conflict of Interest Disclosures: Dr Choueiri reported receiving grants, personal fees, nonfinancial support, and clinical trials, advisory board, consultancy, and manuscript support related to kidney cancer from Bristol-Myers Squibb, Exelixis, Pfizer, Merck, and Roche/Genentech outside the submitted work. Dr Choueiri also reported receiving clinical trials funding from AstraZeneca, Alexion, Bayer, Bristol-Myers Squibb/ER Squibb and Sons LLC, Cerulean, Eisai, Foundation Medicine Inc, Exelixis, Ipsen, Tracon, Genentech, Roche, Roche Products Limited, F. Hoffmann–La Roche, GlaxoSmithKline, Lilly, Merck, Novartis, Peloton, Pfizer, Prometheus Labs, Corvus, Calithera, Analysis Group, Sanofi/Aventis, and Takeda; receiving grants and funding from the National Cancer Institute and US Department of Defense; and relationships with Dana-Farber/Harvard Cancer Center Kidney Specialized Program of Research Excellence (SPORE) and Program, the Kohlberg Chair at Harvard Medical School, the Trust Family, Michael Brigham, and Loker Pinard Funds for Kidney Cancer Research at Dana-Farber Cancer Insitute. Dr Mato reported receiving grants from TG Therapeutics; grants from AbbVie, Adaptive, Celgene, DTRM Biopharma, Genentech, Janssen, Loxo, Pharmacyclics, Regeneron, and Sunesis; personal fees from AbbVie, Adaptive, AstraZeneca, Beigene, Genentech, and TG Therapeutics; and serving on a data safety monitoring board for Celgene and TG Therapeutics. No other disclosures were reported.

Additional Contributions: We thank Deanna Hart, RN, clinical trials manager at the Dana Farber Cancer Institute, for her valuable comments and insightful feedback. She was not compensated for her contributions.

References
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Unger  JM , Vaidya  R , Hershman  DL , Minasian  LM , Fleury  ME .  Systematic review and meta-analysis of the magnitude of structural, clinical, and physician and patient barriers to cancer clinical trial participation.   J Natl Cancer Inst. 2019;111(3):245-255. doi:10.1093/jnci/djy221 PubMedGoogle Scholar
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Wosik  J , Fudim  M , Cameron  B ,  et al.  Telehealth transformation: COVID-19 and the rise of virtual care.   J Am Med Inform Assoc. 2020;27(6):957-962. doi:10.1093/jamia/ocaa067 PubMedGoogle Scholar
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FDA guidance on conduct of clinical trials of medical products during COVID-19 public health emergency: guidance for industry, investigators, and institutional review boards. Updated June 3, 2020. Accessed April 23, 2020. https://www.fda.gov/media/136238/download
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Protocol deviation memorandum for NRG oncology studies. Updated April 14, 2020. Accessed April 26, 2020. https://www.nrgoncology.org/Portals/0/UPDATED-COVID-19%20Deviation%20Memo%20and%20Log_FINAL_04-14-20.pdf?ver=2020-04-15-075631-133
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Kim  YC , Dema  B , Reyes-Sandoval  A .  COVID-19 vaccines: breaking record times to first-in-human trials.   NPJ Vaccines. 2020;5(34):34. doi:10.1038/s41541-020-0188-3 PubMedGoogle Scholar
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COVID-19 and Cancer Consortium Registry (CCC19). ClinicalTrials.gov identifier: NCT04354701. Posted April 21, 2020. Updated May 1, 2020. Accessed July 1, 2020. https://www.clinicaltrials.gov/ct2/show/NCT04354701?term=NCT04354701&draw=2&rank=1
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