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.
Identify all potential conflicts of interest that might be relevant to your comment.
Conflicts of interest comprise financial interests, activities, and relationships within the past 3 years including but not limited to employment, affiliation, grants or funding, consultancies, honoraria or payment, speaker's bureaus, stock ownership or options, expert testimony, royalties, donation of medical equipment, or patents planned, pending, or issued.
Err on the side of full disclosure.
If you have no conflicts of interest, check "No potential conflicts of interest" in the box below. The information will be posted with your response.
Not all submitted comments are published. Please see our commenting policy for details.
Moskowitz CS, Panageas KS. Implications for Design and Analyses of Oncology Clinical Trials During the COVID-19 Pandemic. JAMA Oncol. Published online June 18, 2020. doi:10.1001/jamaoncol.2020.2370
Coronavirus Resource Center
Customize your JAMA Network experience by selecting one or more topics from the list below.
Create a personal account or sign in to: