Pragmatic trials represent a methodological shift in clinical research, aiming to bridge the gap between efficacy demonstrated in controlled settings and effectiveness observed in routine clinical practice. Unlike explanatory trials that prioritize internal validity by tightly controlling variables, pragmatic trials prioritize external validity by mirroring real-world conditions. These trials often involve a broader patient population, with minimal eligibility criteria, and are conducted in typical healthcare settings. Consequently, pragmatic trials generate evidence that is more directly applicable to clinical decision-making.
Key features of pragmatic trials include flexible study designs, such as cluster randomization or stepped wedge designs, to accommodate real-world constraints. Outcome measures are often patient-centered and clinically relevant, reflecting the impact of interventions on daily life. Moreover, pragmatic trials emphasize collaboration between researchers, clinicians, and patients to ensure the relevance and feasibility of the study. While pragmatic trials may sacrifice some degree of internal validity, their ability to provide robust evidence on the real-world impact of interventions is invaluable for informing healthcare policies and practices.
