השוואת שיטות

	ניסוי קליני שלב III מותאם-סיכון	שלב III ניסוי קליני
תחום	אפידמיולוגיה	אפידמיולוגיה
משפחה	Process / pipeline	Process / pipeline
שנת המקור	1980s–present	1962 (Kefauver-Harris Amendment formalised phased drug development)
הוגה השיטה	Evolving practice; foundational risk-adjustment principles established by Pocock (1983) and extended by numerous trialists	FDA regulatory framework / ICH guidelines
סוג	Confirmatory randomized trial with baseline risk stratification and covariate adjustment	Confirmatory randomised controlled trial
מקור מכונן	Pocock, S. J. (1983). Clinical Trials: A Practical Approach. Wiley. ISBN: 978-0471901556	Friedman, L. M., Furberg, C. D., DeMets, D. L., Reboussin, D. M., & Granger, C. B. (2015). Fundamentals of Clinical Trials (5th ed.). Springer. ISBN: 978-3319185385
כינויים	risk-stratified Phase III trial, covariate-adjusted Phase III RCT, risk-adjusted confirmatory trial, RA-Phase III	Phase 3 trial, confirmatory trial, pivotal trial, Phase III RCT
קשורות	6	6
תקציר	A risk-adjusted Phase III clinical trial is a large-scale confirmatory randomized experiment that explicitly incorporates participants' baseline prognostic risk profile into both the randomization process and the primary statistical analysis. By stratifying patients on known risk factors before allocation and adjusting for those factors in the outcome model, the design achieves greater statistical precision, reduces confounding, and produces treatment effect estimates that are more clinically meaningful across patient subgroups.	A Phase III clinical trial is a large-scale, confirmatory randomised controlled trial designed to establish the efficacy and safety of an intervention in the target patient population before regulatory submission. It builds on the signal identified in Phase II, tests the intervention at its proposed dose under controlled conditions, and provides the primary evidence base for marketing authorisation or guideline adoption.