Challenge

Traditional clinical trials have helped scientists find effective treatments and patient care practices. However, the results of clinical trials often apply to only a small group of people because of limitations on who can participate in individual trials. Pragmatic clinical trials look at whether an intervention works for a broad group of patients under usual care conditions. They compare the practical value of a new treatment to existing approaches. The National Institutes of Health (NIH) wants to learn what contributes to the success of pragmatic trials, particularly those that draw on data from existing resources, including electronic medical records.

Solution

We are working closely with 6 NIH grantees who are conducting pragmatic trials. Our goal is to understand how the grantees reach certain milestones, including recruiting study participants and completing the trial on schedule. We are collecting information about the success of their methods and the challenges associated with pragmatic trials.

Results

Our findings will help researchers who design and conduct pragmatic trials and will help NIH make informed decisions about when to discontinue trials that are not meeting established goals.