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Oncology

Rethinking Clinical Trials Reform During the COVID-19 Pandemic

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

1 Credit CME

JAMA Oncology

Published Online: August 6, 2020

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Article Information and Disclosures

Chadi Nabhan, MD, MBA^1,2;

Toni K. Choueiri, MD³;

Anthony R. Mato, MD, MSc⁴

Author Affiliations

¹Caris Life Sciences, Precision Oncology Alliance, Irving, Texas
²Department of Clinical Pharmacy and Outcomes Sciences, University of South Carolina, Columbia
³Dana-Farber Cancer Institute, Boston, Massachusetts
⁴Memorial Sloan Kettering Cancer Center, New York, New York

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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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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.