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| Μετα-αναλυτική Μελέτη Φάσης IV× | Τυχαιοποιημένη Ελεγχόμενη Δοκιμή (ΤΕΔ)× | |
|---|---|---|
| Πεδίο≠ | Επιδημιολογία | Πειραματικός Σχεδιασμός |
| Οικογένεια≠ | Process / pipeline | Hypothesis test |
| Έτος προέλευσης≠ | 1990s–2000s (formalised as regulatory requirement context grew) | 1948 |
| Δημιουργός≠ | Developed through the convergence of meta-analytic methods (Glass, 1976; Hedges & Olkin, 1985) and post-marketing pharmacoepidemiology frameworks | James Lind (early precursor, 1747); modern formulation: Austin Bradford Hill & Medical Research Council (1948) |
| Τύπος≠ | Evidence synthesis applied to post-marketing observational and trial data | Interventional comparative study |
| Θεμελιώδης πηγή≠ | Sutton, A. J., Abrams, K. R., Jones, D. R., Sheldon, T. A., & Song, F. (2000). Methods for Meta-Analysis in Medical Research. Wiley. ISBN: 978-0471490661 | 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 | Phase IV meta-analysis, post-marketing meta-analysis, pharmacoepidemiologic meta-analysis, post-approval systematic review and meta-analysis | RCT, randomised controlled trial, clinical trial, Randomize Kontrollü Çalışma (RCT) Tasarımı |
| Συναφείς≠ | 3 | 7 |
| Σύνοψη≠ | A meta-analytic Phase IV study pools and quantitatively synthesises data from multiple Phase IV (post-marketing) sources — including observational cohorts, registries, spontaneous adverse-event databases, and post-approval randomised trials — to produce a single, more precise estimate of a drug or device's real-world effectiveness, safety, or utilisation pattern. By applying meta-analytic weighting to heterogeneous post-marketing evidence, it bridges the gap between tightly controlled pre-approval trials and the complexity of routine clinical practice. | 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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