Amid the COVID-19 pandemic, clinical trials are running into challenges with how they conduct their research. These challenges may arise from quarantines, site closures, travel limitations, interruptions to the supply chain for the investigational product, re-allocation of clinical trial personnel and resources towards other healthcare duties, and overwhelmed hospitals, resources, and systems. These challenges may lead to difficulties in meeting pre-specified trial protocols and as a result, trials are needing to adapt their processes or, as is the case for many, being put on hold for the foreseeable future.
To help provide guidance during this time, the FDA released a document last updated April 16 on the Conduct Of Clinical Trials Of Medical Products During The COVID-19 Public Health Emergency. This guidance was created to help assure the safety of trial participants and maintain integrity of the clinical trials during COVID-19. At the heart of this document, is the emphasis on participant safety – this must be the primary consideration when deciding whether to suspend, continue, or initiate a trial. Where possible, they recommended trials continue moving forward using alternative methods for safety assessments (e.g., phone contact, virtual visit, alternative location for assessment). At this time, it is not clear the full impact COVID-19 will have on clinical research, but we hope for a best-case scenario where the impacts/delays will be as minimal as possible.