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| Prospektivt randomiseret klinisk forsøg× | Fase III Klinisk Forsøg× | |
|---|---|---|
| Fagområde | Epidemiologi | Epidemiologi |
| Familie | Process / pipeline | Process / pipeline |
| Oprindelsesår≠ | 1948 (landmark MRC streptomycin trial) | 1962 (Kefauver-Harris Amendment formalised phased drug development) |
| Ophavsperson≠ | Austin Bradford Hill / Medical Research Council | FDA regulatory framework / ICH guidelines |
| Type≠ | Experimental / interventional study design | Confirmatory randomised controlled trial |
| Oprindelig kilde≠ | Medical Research Council (1948). Streptomycin treatment of pulmonary tuberculosis: a Medical Research Council investigation. British Medical Journal, 2(4582), 769–782. link ↗ | 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 |
| Aliasser | Prospective RCT, randomized controlled trial, RCT, controlled clinical trial | Phase 3 trial, confirmatory trial, pivotal trial, Phase III RCT |
| Relaterede≠ | 5 | 6 |
| Resumé≠ | A prospective randomized clinical trial (RCT) is an experimental study in which participants are assigned to intervention or control groups by chance before any outcomes are observed, then followed forward in time. Random allocation eliminates systematic selection bias, making this design the gold standard for establishing causal efficacy of treatments in medicine and clinical research. | 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. |
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