השוואת שיטות

	מחקר שלב IV מותאם סיכון	התאמת ציון נטייה
תחום	אפידמיולוגיה	סטטיסטיקה למחקר
משפחה	Process / pipeline	Process / pipeline
שנת המקור	1990s–2000s (formalized with ICH E2E and EMA PASS guidelines)	1983
הוגה השיטה	Regulatory and pharmacoepidemiology community (ICH, EMA, FDA frameworks)	Paul Rosenbaum and Donald Rubin
סוג	Observational / quasi-experimental clinical study design	Method
מקור מכונן	Strom, B. L. (Ed.). (2005). Pharmacoepidemiology (4th ed.). John Wiley & Sons. ISBN: 978-0470863107	Rosenbaum, P. R., & Rubin, D. B. (1983). The central role of the propensity score in observational studies for causal effects. Biometrika, 70(1), 41–55.
כינויים	risk-adjusted post-marketing surveillance study, adjusted Phase IV trial, risk-stratified post-authorization study, PASS with risk adjustment	PSM, propensity score weighting, covariate balance
קשורות	3	3
תקציר	A risk-adjusted Phase IV study is an observational or semi-experimental post-marketing study conducted after a drug or device has received regulatory approval. It uses statistical risk-adjustment techniques — such as propensity score matching, inverse probability weighting, or multivariable regression — to control for confounding by indication and baseline patient differences, thereby producing more credible safety, effectiveness, and utilization estimates than unadjusted real-world analyses.	Propensity score matching (PSM) is a method for reducing confounding bias in observational studies by balancing baseline characteristics between treatment groups, simulating randomization. Developed by Rosenbaum and Rubin (1983), it estimates the probability of receiving treatment given observed covariates, then matches or weights treated and control individuals with similar treatment probabilities. Widely used in medicine, epidemiology, and policy evaluation when randomized trials are infeasible or unethical, enabling estimation of treatment effects while controlling for selection bias.