Recently, public attention has been captured by the progress of medical treatments and vaccines against COVID-19, which are currently going through clinical trials (categorized into phases 1, 2 and 3).¹

Regulatory agencies in the U.S. and other countries tasked with reviewing and approving these and other medical products have been issuing guidelines and Q&A documents to facilitate their expedited development.²

At the same time, medical products for conditions other than COVID-19 have faced significant headwinds with subject recruitment and retainment and the overall conduct of clinical trials.³

Scientists across government agencies, academia and industry are therefore exploring new ways to continue this much-needed work. Possible adjustments range from behavioral and physical modifications, for example, as recommended by the following regulatory agencies:

• Responding to Coronavirus, Cancer Researchers Reimagine Clinical Trials (U.S. National Institutes of Health and National Cancer Institute)
• FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency (U.S. Food and Drug Administration)
• Guidance on the Management of Clinical Trials During the COVID-19 (Coronavirus) Pandemic (European Commission)
• Guidance for Medicine Developers and Companies on COVID-19 (European Medicines Agency)

Further, as explained in the following publications, others have proposed new statistical solutions:

• Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency (FDA Guidance, June 2020)
• Adaptive Designs in Clinical Trials: Pros and Cons, COVID-19 Research, and Probability Theory (Trial Site News, May 2020)
• Efficient Adaptive Designs for Clinical Trials of Interventions for COVID-19 (Taylor & Francis Online, July 2020)
• Pooling Data From Individual Clinical Trials in the COVID-19 Era (JAMA Network, August 2020)

For additional information on these topics or for help with related regulatory issues, please contact Dr. Lana Lyapustina at Faegre Drinker.