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.