COVID-19 and its Implications on How We Conduct Clinical Trials

2:40 PM - 3:00 PM

Design and conduct of clinical trials is never trivial, but clinical research during an infectious disease pandemic can be particularly challenging and often vexing. Public health considerations require added precautions to mitigate risk of subject-to-subject as well as subject-to-study staff transmission, and complicate enrollment in all studies.  Hospital staff and infrastructure are stressed, and clinical research may be de-prioritized.  However,  design and conduct of therapeutic agent  trials designed to address a pandemic pathogen and its effects are during an outbreak particularly challenging.  Standard of care is continuously evolving.  Statistics required for study endpoint powering are difficult to obtain, regional, and fungible.  Incidence and enrollment rates fluctuate wildly. Medical caregivers are often overwhelmed. And assays and relevant endpoints are in constant flux.  Patients predominantly present in community settings that may not be staffed or experienced in clinical research. Lessons learned from Ebola, Zika, influenza and SARS-CoV-2/COVID-19 will be discussed with an emphasis on risk management and mitigation.