Description
The NHLBI convened a Working Group to engage in a dialogue on the development of opportunities to embed clinical trials into observational registries and cohort studies. These efforts would be part of a long-term strategy to transform clinical trials and epidemiology, adapting to the opportunities of big data and the challenges of constrained budgets. The Working Group identified a number of important considerations, including study aims, timing, breadth and depth of the existing infrastructure that can be leveraged, participant burden, likely participation rate and available sample size in the cohort, required sample size for the trial, and investigator expertise. The Working Group also noted that community engagement and stakeholder (including study participants) support are essential for these efforts to succeed.