השוואת שיטות

	ניסוי קליני שלב II	תכנון מחקר דיאגנוסטי
תחום	אפידמיולוגיה	מחקר קליני
משפחה	Process / pipeline	Process / pipeline
שנת המקור	1960s–1970s (formalised in US federal drug regulation)	2003-2015
הוגה השיטה	U.S. Food and Drug Administration / ICH E8 guidelines (institutionalised framework)	Bossuyt, Reitsma, and STARD group (2003); clinical epidemiology pioneers
סוג	Interventional clinical study design	Research Design
מקור מכונן	Friedman, L. M., Furberg, C. D., DeMets, D. L., Reboussin, D. M., & Granger, C. B. (2015). Fundamentals of Clinical Trials (5th ed.). Springer. ISBN: 978-3319185392	Bossuyt, P. M., Reitsma, J. B., Bruns, D. E., Gatsonis, C. A., Glasziou, P. P., Irwig, L. M., ... & de Vet, H. C. (2003). Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative. Annals of Internal Medicine, 138(1), 40–44.
כינויים	Phase 2 trial, Phase II study, early efficacy trial, proof-of-concept trial	diagnostic accuracy study, test accuracy, STARD, diagnostic evaluation
קשורות	6	2
תקציר	A Phase II clinical trial is the second stage in the drug or intervention development pipeline, conducted after Phase I safety testing. Its primary goal is to assess whether the intervention shows preliminary efficacy signals in a relevant patient population at the dose established in Phase I, while continuing to characterise the safety and tolerability profile. Phase II trials are generally smaller than Phase III confirmatory trials and serve as critical go/no-go decision points before large-scale investment.	A diagnostic accuracy study evaluates how well a new diagnostic test (or biomarker, imaging modality, clinical assessment) detects the presence or absence of disease compared to a reference standard (gold standard). Standardized since 2003 by the STARD (Standards for Reporting of Diagnostic Accuracy Studies) initiative, diagnostic accuracy studies are fundamental to clinical medicine, determining whether and how new tests can improve patient diagnosis and treatment.