手法を比較

	パイロット無作為化比較試験	ランダム化比較試験 (RCT)
分野	実験計画法	実験計画法
系統	Process / pipeline	Hypothesis test
提唱年	1990s–2000s (methodological formalization)	1948
提唱者	Formalized through clinical trials methodology community	James Lind (early precursor, 1747); modern formulation: Austin Bradford Hill & Medical Research Council (1948)
種類	Experimental feasibility design	Interventional comparative study
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.	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.
別名	pilot RCT, feasibility RCT, pilot trial, preliminary RCT	RCT, randomised controlled trial, clinical trial, Randomize Kontrollü Çalışma (RCT) Tasarımı
関連	5	7
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 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).