In the year since COVID-19 made landfall in our lives, life sciences companies have pivoted quickly to address what has become the largest global public health crisis of the century. The industry is pouring tremendous energy and resources into this effort. To date, the U.S. Food and Drug Administration (FDA) has reviewed more than 350 trials for potential therapeutics. Here at Syneos Health, we are supporting more than 80 active COVID-19 research and development (R&D) projects, including vaccines and therapeutics.
While the current environment has defied most attempts to predict what’s next, a few key learnings from a clinical development perspective suggest where we might be headed. It seems clear, for example, that vaccines are unlikely to eliminate the need for therapeutics in the near term. We need multiple therapeutic options across disease severities, and we need them now. Mortality rates (inpatient) and hospitalization rates (outpatient) will continue to be key endpoints of interest. We need far more representation from high-risk groups in clinical trials. Clinical mindsets and practices will vary (by region, institution and among HCPs). Key stakeholders will all demand to “show me” not only safety and efficacy but the real world evidence needed to support potential new products. After COVID stabilizes, the need will grow for long-term safety and efficacy data.
Pivoting fast amidst disruption
From a commercialization perspective, however, the reality for drug and vaccine developers is that no one quite knows where we will be in six months. Events are moving so fast and the need is so urgent that a milestone signaling promise or disappointment for one COVID-19 asset has the potential to alter, in real time, the road map to commercial success for many others.
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