Pragmatic phase III clinical trial
A pragmatic phase III clinical trial is a large-scale randomized study designed to evaluate whether an intervention works under the conditions of everyday clinical practice rather than the tightly controlled environment of an explanatory efficacy trial. It recruits a broad, representative patient population, allows flexibility in treatment delivery, and measures outcomes that matter to patients and health systems, generating evidence directly applicable to real-world treatment decisions.
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- 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
- Ford, I., & Norrie, J. (2016). Pragmatic trials. New England Journal of Medicine, 375(5), 454–463. · DOI 10.1056/NEJMra1510059
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