Evaluating the feasibility of data sources for pragmatic clinical trials

Abstract Feasibility assessment is an important step before initiating any research study, including pragmatic clinical trials. Choosing the correct data source safeguards against substantial difficulties later in the design and implementation process. Based on availability and adequacy of systems already collecting data, it may be viable to embed a pragmatic randomized clinical trial within an already existing data source. Electronic health records (EHR) and administrative insurance (“claims”) data may provide opportunities for embedded pragmatic trials. The feasibility of using EHR, claims, or other ongoing data collection for analysis in a pragmatic trial depends on the specific research question and the availability, quality and relevance of the collected data needed to address that question. This chapter describes considerations for determining whether existing real-world data (RWD) sources can be used for specific pragmatic trials and highlights a structured approach for assessing the feasibility of these data in pragmatic clinical trial research.