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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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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.
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 (email@example.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.
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