Collaborative Platform Trials to Fight COVID-19: Methodological and Regulatory Considerations for a Better Societal Outcome.

ABSTRACT: For the development of coronavirus disease 2019 (COVID-19) drugs during the ongoing pandemic, speed is of essence whereas quality of evidence is of paramount importance. Although thousands of COVID-19 trials were rapidly started, many are unlikely to provide robust statistical evidence and meet regulatory standards (e.g., because of lack of randomization or insufficient power). This has led to an inefficient use of time and resources. With more coordination, the sheer number of patients in these trials might have generated convincing data for several investigational treatments. Collaborative platform trials, comparing several drugs to a shared control arm, are an attractive solution. Those trials can utilize a variety of adaptive design features in order to accelerate the finding of life-s

SUBMITTER: Collignon O 

PROVIDER: S-EPMC8014457 | biostudies-literature | 2021 Aug

REPOSITORIES: biostudies-literature