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| Risikoadjustierte klinische Phase-III-Studie× | Randomisierte klinische Studie (RCT)× | |
|---|---|---|
| Fachgebiet | Epidemiologie | Epidemiologie |
| Familie | Process / pipeline | Process / pipeline |
| Entstehungsjahr≠ | 1980s–present | 1948 (first rigorously conducted RCT — MRC streptomycin trial) |
| Urheber≠ | Evolving practice; foundational risk-adjustment principles established by Pocock (1983) and extended by numerous trialists | Austin Bradford Hill; MRC Streptomycin Trial team |
| Typ≠ | Confirmatory randomized trial with baseline risk stratification and covariate adjustment | Interventional experimental study |
| Wegweisende Quelle≠ | 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 |
| Aliasnamen | risk-stratified Phase III trial, covariate-adjusted Phase III RCT, risk-adjusted confirmatory trial, RA-Phase III | RCT, randomized controlled trial, randomised controlled trial, clinical randomized trial |
| Verwandt | 6 | 6 |
| Zusammenfassung≠ | 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 randomized clinical trial (RCT) is an experimental study design in which participants are randomly assigned to an intervention group or a control group, then followed prospectively to compare outcomes. Random allocation is the defining feature: it distributes known and unknown confounders across groups by chance, making the RCT the strongest individual study design for establishing causal efficacy of a treatment or intervention under controlled conditions. |
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