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| Τροποποιημένη Τυχαιοποιημένη Κλινική Δοκιμή Φάσης III× | Τυχαιοποιημένη Ελεγχόμενη Δοκιμή (ΤΕΔ)× | |
|---|---|---|
| Πεδίο≠ | Επιδημιολογία | Πειραματικός Σχεδιασμός |
| Οικογένεια≠ | Process / pipeline | Hypothesis test |
| Έτος προέλευσης≠ | Mid-20th century (matching in RCTs formalized ~1950s–1970s) | 1948 |
| Δημιουργός≠ | Fisher, R. A. (matching principles); adapted into confirmatory trial design over mid-20th century | James Lind (early precursor, 1747); modern formulation: Austin Bradford Hill & Medical Research Council (1948) |
| Τύπος≠ | Controlled confirmatory clinical trial with matching | Interventional comparative study |
| Θεμελιώδης πηγή≠ | Rothman, K. J., Greenland, S., & Lash, T. L. (2008). Modern Epidemiology (3rd ed.). Lippincott Williams & Wilkins. ISBN: 978-0781755641 | Schulz, K.F., Altman, D.G., Moher, D., for the CONSORT Group (2010). CONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomised Trials. BMJ, 340, c332. DOI ↗ |
| Εναλλακτικές ονομασίες | matched controlled Phase III trial, Phase III matched-pair trial, matched confirmatory trial, matched late-phase RCT | RCT, randomised controlled trial, clinical trial, Randomize Kontrollü Çalışma (RCT) Tasarımı |
| Συναφείς≠ | 5 | 7 |
| Σύνοψη≠ | A matched Phase III clinical trial is a confirmatory, late-stage controlled study in which each participant assigned to the experimental treatment is paired with one or more controls who share key prognostic characteristics — such as age, disease stage, or comorbidities — before treatment allocation. By ensuring baseline comparability at the level of matched pairs, the design reduces confounding and improves statistical efficiency in settings where simple randomization alone may produce imbalanced groups or where full randomization is logistically or ethically constrained. | A randomized controlled trial (RCT) is the gold standard experimental design in clinical and health research, in which participants are randomly allocated to a treatment group or a control group so that the effect of an intervention can be measured with the highest possible degree of internal validity. The modern parallel-group RCT was formalized by Austin Bradford Hill and the Medical Research Council in their landmark streptomycin trial of 1948, and its reporting is governed today by the CONSORT 2010 guidelines (Schulz et al., 2010). |
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