PCT

Pragmatic Clinical Trial (PCT)

EU: imi GetReal Glossary – A study comparing health interventions among a randomised, diverse population representing clinical practice, and measuring a broad range of health outcomes. To ensure generalizability, pragmatic trials should represent the intended patients to whom the treatment will be applied as best as possible. For instance, inclusion criteria would be broad (e.g. allowing co-morbidity, co-medication, wider age range, etc.), the follow-up would not be (or not much) interventional and allowing for treatment switching etc. (See also “large simple trials” and “real-world studies”) [Source: imi GetReal Glossary – 25 Oct 2016 Adapted from Schwartz, 1967, Tunis, 2003 & Roland, 1998]* * Schwartz, D., & Lellouch, J. (1967). Explanatory and pragmatic attitudes in therapeutical trials. Journal of chronic diseases, 20(8), 637-648.; Tunis, S. R., Stryer, D. B., & Clancy, C. M. (2003). Practical clinical trials: increasing the value of clinical research for decision making in clinical and health policy. Jama, 290(12), 1624-1632.; Roland, M. and D.J. Torgerson, What are pragmatic trials? BMJ, 1998. 316(7127): p. 285.

China: Key Considerations in Using Real-World Evidence to Support Drug Development – A clinical trial that is designed and conducted in an environment as close as possible to the clinical real world. It is a type of research between RCTs and observational studies. Unlike RCTs, PCT interventions can be either standardized or non-standardized; subjects in the PCTs can be randomized or allocated per pre-defined criteria; the inclusion criteria for the subjects are often less restrict and considered more representative of the target population, and the evaluation of intervention outcomes may not be limited to clinical efficacy and safety. On the other hand, unlike observational studies, PCTs are intervention studies, although the interventions are often designed with additional flexibility (as per Key Considerations in Using Real-World Evidence to Support Drug Development (Draft for Public Review) – Center for Drug Evaluation, NMPA – May, 2019)