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US Food and Drug Administration Support for Oncology Drug Development During COVID-19

Educational Objective
To understand the US Food and Drug Administration support for oncology drug development during COVID-19
1 Credit CME

The coronavirus disease 2019 (COVID-19) pandemic has challenged health care systems worldwide in many ways, from the need for accurate and accessible diagnostics to inform disease surveillance to the importance of creating surge capacity to enable hospitals to meet patient demand. Notable among these challenges has been the pandemic’s effect on the global clinical research enterprise, particularly in oncology.

Like all trials, clinical studies in oncology are resource intensive and require significant logistical coordination to ensure participant safety and data integrity. Oncology trials also often have several unique considerations due to disease severity, regimen complexity, and acute care requirements. The pandemic has introduced a number of challenges for investigators and patients alike, ranging from ensuring access to medication to minimizing infection risk for potentially immunocompromised patients.

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Article Information

Corresponding Author: Anand Shah, MD, US Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD 20993 (anand.shah@fda.hhs.gov).

Published Online: October 8, 2020. doi:10.1001/jamaoncol.2020.4975

Conflict of Interest Disclosures: None reported.

References
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US Food and Drug Administration. FDA guidance on conduct of clinical trials of medical products during COVID-19 public health emergency. Updated July 2, 2020. Accessed June 14, 2020. https://www.fda.gov/media/136238/download
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Kormanik  NL , Chan  M , Boehmer  J , Kim  T , Blumenthal  GM , Pazdur  R .  Project Facilitate: a review of the FDA oncology center of excellence expanded access pilot program.   J Clin Oncol. 2020;38(15)(suppl):7023. doi:10.1200/JCO.2020.38.15_suppl.7023 Google ScholarCrossref
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US Food and Drug Administration. Hematology/oncology (cancer) approvals & safety notifications. Accessed June 14, 2020. https://www.fda.gov/drugs/resources-information-approved-drugs/hematologyoncology-cancer-approvals-safety-notifications
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Beaver  JA , Ison  G , Pazdur  R .  Reevaluating eligibility criteria—balancing patient protection and participation in oncology trials.   N Engl J Med. 2017;376(16):1504-1505. doi:10.1056/NEJMp1615879 PubMedGoogle ScholarCrossref
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US Food and Drug Administration. Coronavirus (COVID-19) update: FDA collaborations promote rigorous analyses of real-world data to inform pandemic response. News release. Updated May 19, 2020. Accessed June 14, 2020. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-collaborations-promote-rigorous-analyses-real-world-data-inform
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US Food and Drug Administration. Project Patient Voice. Updated June 23, 2020. Accessed August 30, 2020. https://www.fda.gov/about-fda/oncology-center-excellence/project-patient-voice
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