手法を比較

	多施設共同診断精度の検証研究	多施設共同無作為化臨床試験
分野	疫学	疫学
系統	Process / pipeline	Process / pipeline
提唱年	2003 (STARD statement first published; updated 2015)	1970s–1980s (widespread adoption for large-scale efficacy trials)
提唱者	STARD Group (Bossuyt, Reitsma et al.)	Evolved from single-center RCT methodology; consolidated through landmark trials such as the MRC streptomycin trial (1948) and large cardiovascular mega-trials of the 1970s–1980s
種類	Observational diagnostic study design	Interventional experimental design
原典	Bossuyt, P. M., Reitsma, J. B., Bruns, D. E., Gatsonis, C. A., Glasziou, P. P., Irwig, L., Lijmer, J. G., Moher, D., Rennie, D., de Vet, H. C. W., Kressel, H. Y., Rifai, N., Golub, R. M., Altman, D. G., Hooft, L., Korevaar, D. A., & Cohen, J. F. (2015). STARD 2015: An Updated List of Essential Items for Reporting Diagnostic Accuracy Studies. BMJ, 351, h5527.	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
別名	multisite diagnostic accuracy study, multicenter DTA study, multicenter index test evaluation, STARD multicenter study	multi-site RCT, multicenter RCT, multinational randomized trial, multicenter controlled trial
関連	5	6
概要	A multicenter diagnostic accuracy study evaluates how well an index test (e.g., a biomarker, imaging modality, or clinical prediction rule) identifies a target condition when conducted across two or more independent clinical sites. By recruiting patients from diverse settings, it produces estimates of sensitivity, specificity, and likelihood ratios that are more externally valid than those obtained from a single center, and it enables explicit assessment of how test performance varies across sites, patient populations, and operator skill levels.	A multicenter randomized clinical trial (RCT) is an experimental study in which eligible participants are randomly assigned to intervention or control arms simultaneously across two or more clinical sites. By combining the rigor of randomization with enrollment from geographically or institutionally diverse centers, this design produces large samples and externally valid effect estimates that single-center trials rarely achieve. It is the regulatory gold standard for confirmatory efficacy and safety evaluation of new treatments.