Pros and cons of pragmatic clinical trials

Traditional randomized controlled trials are the 'gold standard' for evaluating health interventions and are typically designed to maximize internal validity, often at the cost of limited generalizability. Pragmatic randomized controlled trials should be designed with a conscious effort to generate evidence with a greater external validity by making the research question as similar as possible to the questions faced by clinical decision-makers (i.e., patients and their families, physicians, policy makers and administrators) and then answer that question with rigor. Clarity and transparency about the specifics of the research question are the keys to designing, as well as interpreting, any clinical trial.