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| パイロット無作為化比較試験× | クロスオーバーランダム化比較試験(Crossover Randomized Controlled Trial)× | |
|---|---|---|
| 分野 | 実験計画法 | 実験計画法 |
| 系統 | Process / pipeline | Process / pipeline |
| 提唱年≠ | 1990s–2000s (methodological formalization) | 1960s (Grizzle 1965 for statistical foundations); widely used in clinical research since the 1970s |
| 提唱者≠ | Formalized through clinical trials methodology community | Early formalized by statisticians including Bradford Hill and colleagues in clinical trials; theoretical framework developed by Grizzle (1965) and later Senn (2002) |
| 種類≠ | Experimental feasibility design | Experimental within-subject design |
| 原典≠ | Thabane, L., Ma, J., Chu, R., Cheng, J., Ismaila, A., Rios, L. P., ... & Goldsmith, C. H. (2010). A tutorial on pilot studies: the what, why and how. BMC Medical Research Methodology, 10(1), 1. DOI ↗ | Senn, S. (2002). Cross-over Trials in Clinical Research (2nd ed.). Wiley. ISBN: 978-0471496533 |
| 別名 | pilot RCT, feasibility RCT, pilot trial, preliminary RCT | crossover RCT, crossover trial, within-subject RCT, AB/BA crossover design |
| 関連 | 5 | 5 |
| 概要≠ | A pilot randomized controlled trial (pilot RCT) is a small-scale, fully randomized experiment conducted before a definitive RCT to test the feasibility of study procedures, estimate key parameters such as recruitment rates and effect-size variability, and identify practical barriers. It uses the same randomization, intervention, and measurement protocol as the planned full trial but on a fraction of the target sample. The goal is not to confirm efficacy but to refine and justify the main trial design. | A crossover randomized controlled trial (crossover RCT) is an experimental design in which each participant receives all study interventions in a randomized sequence, separated by a washout period. Because every participant serves as their own control, within-subject variability is eliminated from the treatment comparison, yielding greater statistical power per participant than a parallel-group RCT of equal size. |
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