The following quote is attributed to Janet Woodcock, M.D., Acting FDA Commissioner
“During this global pandemic, the FDA worked to protect the American public by using every tool at its disposal to quickly review and act on new therapies for COVID-19.
Conducting clinical trials to see if a drug is safe and effective can be a very time-consuming process. To meet the urgent demand for effective therapies, FDA has worked with clinical trial experts to rapidly advance best practices in the design and execution of clinical trials. Today, we’re providing industry guidance for creating master protocols (an overarching protocol designed to answer multiple questions) when evaluating drugs for the treatment or prevention of COVID-19.
In COVID-19, master protocols have been used to evaluate multiple drugs at the same time. The Accelerating COVID-19 Therapeutics Interventions and Vaccines (ACTIV) public-private initiative coordinated by the Foundation for the National Institutes of Health is one excellent example of master protocols being used to simultaneously study a number of promising drugs.
Master protocols that are well designed and executed can accelerate drug development by maximizing the amount of information obtained from the research effort. These trials can be updated to incorporate new scientific information, as medical science advances. Master protocols also reduce administrative costs and time associated with starting up new trial sites for each investigational drug. They can also increase data quality and efficiency through shared and reusable infrastructure. These advantages are of particular importance during a public health emergency such as the current SARS-CoV-2 pandemic, where there is a critical need for efficient drug development.
The FDA expects master protocols to continue to play an important role in addressing the public health needs created by the pandemic and in generating clinical evidence in general.”