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Oncology

Trends in Oncology Clinical Trials Launched Before and During the COVID-19 Pandemic

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

1 Credit CME

JAMA Network Open

Published Online: January 27, 2021

Research Letter

Article Information and Disclosures

Elizabeth B. Lamont, MD, MS, MMSc¹;

Sheila S. Diamond, MS²;

Ron G. Katriel, PhD²;

Lisa L. Ensign, PhD²;

Jingshu Liu, MS²;

Emelly Rusli, MPH¹;

G. Caleb Alexander, MD, MS^3,4,5

Author Affiliations

¹Acorn AI, by Medidata, a Dassault Systèmes Company, Boston, Massachusetts
²Acorn AI, by Medidata, a Dassault Systèmes Company, New York, New York
³Center for Drug Safety and Effectiveness, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland
⁴Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland
⁵Department of Medicine, Johns Hopkins Medicine, Baltimore, Maryland

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The coronavirus disease 2019 (COVID-19) pandemic due to the novel severe acute respiratory syndrome coronavirus 2 has resulted in significant morbidity and mortality since its genesis in China in late 2019, with an estimated 1 602 500 deaths and 71 541 897 infections throughout the world as of December 12, 2020.¹ The pandemic’s direct impact on population health and associated collateral morbidity and mortality resulting from delays in care for disparate conditions have been described elsewhere.²^- 6 We evaluated the association between the pandemic and clinical research and development for an as yet non-COVID-19–associated condition, cancer, by studying the initiation of oncology clinical trials over time.

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Article Information

Accepted for Publication: December 14, 2020.

Published: January 27, 2021. doi:10.1001/jamanetworkopen.2020.36353

Open Access: This is an open access article distributed under the terms of the CC-BY-NC-ND License. © 2021 Lamont EB et al. JAMA Network Open.

Corresponding Author: Elizabeth B. Lamont, MD, MS, MMSc, Acorn AI, by Medidata, a Dassault Systèmes Company, 110 High St, Boston, MA 02110 (elamont@mdsol.com).

Author Contributions: Drs Lamont and Katriel 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: Lamont, Diamond, Alexander.

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

Drafting of the manuscript: Lamont, Rusli.

Critical revision of the manuscript for important intellectual content: Lamont, Diamond, Katriel, Ensign, Liu, Alexander.

Statistical analysis: Lamont, Katriel, Ensign, Liu, Rusli.

Administrative, technical, or material support: Lamont, Diamond, Katriel, Liu.

Supervision: Lamont, Diamond.

Conflict of Interest Disclosures: Dr Lamont reported receiving an honorarium from IQVIA. Ms Diamond reported being a paid clinical consultant for Brigham and Women’s Hospital and Harvard Medical School’s Department of Medicine, Division of Genetics. Dr Alexander reported being past Chair of the US Food and Drug Administration’s Peripheral and Central Nervous System Advisory Committee; serving as a paid advisor to IQVIA; being a cofounding principal and equity holder in Monument Analytics, a health care consultancy whose clients include the life sciences industry as well as plaintiffs in opioid litigation; and being a member of OptumRx’s National P&T Committee. This arrangement has been reviewed and approved by Johns Hopkins University in accordance with its conflict of interest policies. Dr Alexander was not compensated for his contributions to this project. No other disclosures were reported.

Meeting Presentation: An abstract related to this study was presented as a virtual poster at the American Association for Cancer Research COVID and Cancer Meeting; July 20-22, 2020.

Additional Contributions: The following Medidata employees worked on an antecedent Medidata Institute white paper and ongoing analyses related to coronavirus disease 2019 impact on clinical trials, which contributed to the data aggregation for this study: Robbie Buderi, BA, Josh Hartman, MA, Rachel Horovitz, MSc, MBA, Laura Katz, MA, Fareed Melhem, MBA, Trey Moore, BS, Bentz Raphael, BS, Matthew Stetz, PhD, and Aniketh Talwai, MBA. Iman Abba, BS and Jacqueline Bilan, BS of Acorn AI, by Medidata provided research support.

References

Johns Hopkins University and Medicine. Coronavirus resource center. Accessed December 12, 2020. https://coronavirus.jhu.edu/

Mann DM , Chen J , Chunara R , Testa PA , Nov O . COVID-19 transforms health care through telemedicine: evidence from the field. J Am Med Inform Assoc. 2020;27(7):1132-1135. doi:10.1093/jamia/ocaa072 PubMed Google Scholar Crossref

Lange SJ , Ritchey MD , Goodman AB , et al. Potential indirect effects of the COVID-19 pandemic on use of emergency departments for acute life-threatening conditions—United States, January–May 2020. MMWR Morb Mortal Wkly Rep. 2020;69(25):795-800. doi:10.15585/mmwr.mm6925e2 PubMed Google Scholar Crossref

Weinberger DM , Chen J , Cohen T , et al. Estimation of excess deaths associated with the COVID-19 pandemic in the United States, March to May 2020. JAMA Intern Med. 2020;180(10):1336-1344. doi:10.1001/jamainternmed.2020.3391 PubMed Google Scholar Crossref

Kaufman HW , Chen Z , Niles J , Fesko Y . Changes in the number of US patients with newly identified cancer before and during the coronavirus disease 2019 (COVID-19) pandemic. JAMA Netw Open. 2020;3(8):e2017267. doi:10.1001/jamanetworkopen.2020.17267 PubMed Google Scholar

Ayanian JZ . Tallying the toll of excess deaths from COVID-19. JAMA Health Forum. Published online July 1, 2020. doi:10.1001/jamahealthforum.2020.0832 Google Scholar

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.