In this commentary in Clinical and Translational Science, the authors urge the global translational and quantitative pharmacology community to come together and contribute our tools and know-how to fight COVID-19 and prepare for future pandemics.
Many clinical studies for COVID-19 are underpowered, redundant, and not likely to be pooled for analysis. We are wasting valuable resources. We should be channeling these resources to efforts that have a higher likelihood of providing additional, new information in identifying the right drugs and combination therapies as well as vaccines to fight COVID-19.
“Our toolbox allows developing smarter trial designs, including approaches such as umbrella designs, incorporating dose regimen diversity; PK/PD evaluations, even in real-time, leveraging biosimulation to optimize dose regimens that may not have been formally studied, and applying model-based meta-analysis approaches to explore the impact of dose on efficacy from across multiple dose arms and trials.”
Authors: Dan Hartman MD, Steven Kern PhD, Fran Brown PhD, Suzanne K. Minton PhD, and Craig R. Rayner PharmD