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다기관 선별검사 평가×다기관 무작위 배정 임상시험×
분야역학역학
계열Process / pipelineProcess / pipeline
기원 연도1976–2003 (core diagnostic accuracy framework; multicenter STARD standards formalized 2003)1970s–1980s (widespread adoption for large-scale efficacy trials)
창시자Methodological consensus (STARD group, Bossuyt et al.); broader diagnostic accuracy tradition rooted in Hanley & McNeil (1982) and Sackett & Haynes (1976)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
유형Observational diagnostic accuracy studyInterventional experimental design
원전Bossuyt, P. M., Reitsma, J. B., Bruns, D. E., Gatsonis, C. A., Glasziou, P. P., Irwig, L. M., Lijmer, J. G., Moher, D., Rennie, D., & de Vet, H. C. W. (2003). Towards complete and accurate reporting of studies of diagnostic accuracy: The STARD Initiative. Annals of Internal Medicine, 138(1), 40-44. DOI ↗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
별칭multicenter diagnostic accuracy study, multisite screening evaluation, multicenter test performance study, multicenter DTA studymulti-site RCT, multicenter RCT, multinational randomized trial, multicenter controlled trial
관련66
요약A multicenter screening test evaluation measures the diagnostic accuracy of a screening test — its sensitivity, specificity, predictive values, and ROC-curve area — by enrolling participants across two or more independent clinical sites. Conducting the study at multiple centers broadens the patient spectrum, tests generalizability across different laboratory conditions and patient populations, and produces more externally valid accuracy estimates than a single-center study.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.
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