Pragmatic phase II clinical trial
A pragmatic Phase II clinical trial is an early-to-mid-stage interventional study that evaluates a new treatment's preliminary efficacy and safety under conditions that approximate real-world clinical practice rather than tightly controlled experimental settings. It sits between pure explanatory Phase II trials and large pragmatic Phase III confirmatory trials, prioritising practical feasibility and clinical relevance while still generating the signal needed to justify further development.
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- Schwartz, D., & Lellouch, J. (1967). Explanatory and pragmatic attitudes in therapeutical trials. Journal of Chronic Diseases, 20(8), 637–648. · DOI 10.1016/0021-9681(67)90041-0
- 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
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