Summary
There is an urgent need for effective anti-viral drugs to combat the COVID-19 crisis. The identification and development of these drugs depend on effective clinical trials. However, there are tremendous challenges for the development of drug therapies under pandemic conditions, even for drugs repurposed from other indications. Current barriers that have limited previous trials include lack of pathophysiologic understanding of disease, unoptimized dose, operational and regulatory difficulties, poorly defined therapeutic timing windows, broad non-specific outcome measures, non-randomized and underpowered trial designs. As a result, though the knowledge previous trials have provided has been invaluable, conclusive results are lacking. Despite crisis conditions, we cannot forsake the need for well-designed clinical trials. We present 3 key ideas, namely, adhering to translational science principles, leveraging innovative trial design and implementing 4R concept to increase likelihood of trial success and to produce high-quality data. Furthermore, we think it is particularly important to establish Global Clinical Trial models (e.g., adaptive platform trials) that can be implemented rapidly wherever a new pandemic breaks out. Conducting such trials is certainly a tremendous undertaking that will need significant resources and commitment. This will require international cooperation and a shift in the global pharmaceutics research landscape. Finally, we hope that this unprecedented pandemic will lead to development of more robust infectious disease research infrastructure and funding to help mitigate future pandemics.