Preserving Clinical Trial Integrity During the Coronavirus Pandemic
Mary Mcdermott, Anne B. Newman
Abstract
Preserving Clinical Trial Integrity During the Coronavirus PandemicRandomized clinical trials provide the highestquality evidence for identifying therapies to help people attain longer and healthier lives.As of March 2020, ClinicalTrials.govlisted 262 366 ongoing randomized clinical trials, including 146 420 trials studying drug or biologic interventions, 85 045 trials of behavioral interventions, and 61 351 trials of surgical or device interventions. 1 Suddenly, and quite dramatically, the coronavirus pandemic threatens the integrity of these clinical trials.The National Institutes of Health has advised investigators to consult with their institutional review boards and institutions about potential measures to protect participants and research staff.Responses from academic medical center and other research groups have varied from mandatory suspension of research involving human participants (except when this increases risk to participants) to relying on principal investigator discretion.Coronavirus mitigation efforts include selfisolation and avoiding health care centers where symptomatic patients congregate for medical care and where randomized trials are typically conducted.Mitigation efforts interfere with all aspects of a successful clinical trial: efficient accrual and randomization, intervention