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June 18, 2020

Implications for Design and Analyses of Oncology Clinical Trials During the COVID-19 Pandemic

Author Affiliations
  • 1Memorial Sloan Kettering Cancer Center, Department of Epidemiology and Biostatistics, New York, New York
JAMA Oncol. Published online June 18, 2020. doi:10.1001/jamaoncol.2020.2370

Current enforcement of quarantines for patients and staff, site closures, postponement of nonurgent medical appointments, and interruptions to supply chains for investigational products are leading to challenges in meeting protocol-specified procedures required for assessment of clinical trial end points. The recent report put forth by the US Food and Drug Administration recognizes that the conduct of clinical trials may be affected during this time.1 Published recommendations by McDermott and Newman2 in JAMA suggest several solutions for maintaining trial integrity across a broad spectrum of clinical trials. However, the direct implications for the design and analyses of end points specifically from ongoing oncology clinical trials that critically depend on serial data collection have not yet been addressed.

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