Pragmatic phase IV study
A pragmatic Phase IV study is a post-marketing investigation conducted under routine clinical conditions to evaluate a drug or device's real-world effectiveness, long-term safety, and comparative performance. Unlike the controlled Phase III environment, it intentionally minimizes protocol restrictions — broad eligibility criteria, standard-of-care comparators, and naturalistic follow-up — to generate evidence directly applicable to everyday clinical practice.
Source record
Citations copied verbatim from the method’s source record. No claim-level verification is inferred from them.
- Thorpe, K. E., Zwarenstein, M., Oxman, A. D., Treweek, S., Furberg, C. D., Altman, D. G., ... & Chalkidou, K. (2009). A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers. Journal of Clinical Epidemiology, 62(5), 464-475. · DOI 10.1016/j.jclinepi.2008.12.011
- Atkinson, M. J., & Lennox, R. D. (2012). Planning pragmatic clinical trials in Phase IV: pragmatic versus explanatory studies in post-marketing evaluation. Contemporary Clinical Trials, 33(2), 213-218. · URL
Curated claims
Claims persisted in the evidence ledger, each with its own assessment.
This view does not invent a claim assessment when the ledger has none.
Related methods
Generated from the method graph and shown as machine-suggested relations — no evidence claim is inferred.