השוואת שיטות

	ניסוי קליני פְּרַגְמָטִי שלב II	שלב III ניסוי קליני פרגמטי
תחום	אפידמיולוגיה	אפידמיולוגיה
משפחה	Process / pipeline	Process / pipeline
שנת המקור	Pragmatic framework: 1967; Phase II application: 1990s–2000s	1967 (Schwartz & Lellouch); formalized further in 2000s–2010s
הוגה השיטה	Conceptual basis: Daniel Schwartz & Joseph Lellouch (pragmatic vs. explanatory distinction, 1967); applied to Phase II context by drug developers and trialists from the 1990s onward	Schwartz & Lellouch (distinction between pragmatic and explanatory trials)
סוג	Interventional study design	Randomized controlled trial design
מקור מכונן	Schwartz, D., & Lellouch, J. (1967). Explanatory and pragmatic attitudes in therapeutical trials. Journal of Chronic Diseases, 20(8), 637–648.	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.
כינויים	pragmatic Phase II trial, real-world Phase II trial, Phase II pragmatic RCT, Phase IIb pragmatic trial	pragmatic RCT, effectiveness trial, real-world RCT, pragmatic trial
קשורות	6	2
תקציר	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.	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.