Process / pipelinetrial design
Pragmatic Clinical Trial
A pragmatic trial is designed to evaluate the real-world effectiveness of an intervention in typical clinical settings with diverse, representative patients, minimal exclusion criteria, and clinically relevant outcomes. Developed by Thorpe and colleagues (2009) and formalized via the PRECIS-2 framework (2015), pragmatic trials bridge the gap between explanatory efficacy trials (conducted in controlled research settings) and implementation science, answering the question 'Does this work in actual clinical practice?' rather than 'Can this work under ideal conditions?'
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Sources
- Thorpe, K. E., Zwarenstein, M., Oxman, A. D., Treweek, S., Furberg, C. D., Altman, D. G., ... & Tugwell, P. (2009). A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers. CMAJ, 180(10), E47–E57. DOI: 10.1503/cmaj.090523 ↗
- Loudon, K., Treweek, S., Sullivan, F., Donnan, P., Thorpe, K. E., & Zwarenstein, M. (2015). The PRECIS-2 tool: designing trials that are fit for purpose. BMJ, 350, h2147. DOI: 10.1136/bmj.h2147 ↗
- Glasziou, P., Altman, D. G., Bossuyt, P., Boutron, I., Clarke, M., Julious, S., ... & Moher, D. (2018). Reducing waste from incomplete or unusable reports of biomedical research. The Lancet, 383(9913), 267–276. DOI: 10.1016/S0140-6736(13)62228-X ↗