Methoden vergleichen

	Prospektive randomisierte klinische Studie	Pragmatische randomisierte klinische Studie
Fachgebiet	Epidemiologie	Epidemiologie
Familie	Process / pipeline	Process / pipeline
Entstehungsjahr	1948 (landmark MRC streptomycin trial)	1967
Urheber	Austin Bradford Hill / Medical Research Council	Daniel Schwartz & Joseph Lellouch
Typ	Experimental / interventional study design	Interventional study design
Wegweisende Quelle	Medical Research Council (1948). Streptomycin treatment of pulmonary tuberculosis: a Medical Research Council investigation. British Medical Journal, 2(4582), 769–782.	Schwartz, D., & Lellouch, J. (1967). Explanatory and pragmatic attitudes in therapeutical trials. Journal of Chronic Diseases, 20(8), 637–648.
Aliasnamen	Prospective RCT, randomized controlled trial, RCT, controlled clinical trial	pragmatic RCT, effectiveness trial, real-world RCT, practical clinical trial
Verwandt	5	6
Zusammenfassung	A prospective randomized clinical trial (RCT) is an experimental study in which participants are assigned to intervention or control groups by chance before any outcomes are observed, then followed forward in time. Random allocation eliminates systematic selection bias, making this design the gold standard for establishing causal efficacy of treatments in medicine and clinical research.	A pragmatic randomized clinical trial (pragmatic RCT) is an interventional study that tests whether a treatment works under routine clinical conditions, as opposed to the tightly controlled setting of an explanatory trial. It prioritizes broad eligibility, flexible delivery, and patient-relevant outcomes to answer the question 'Does this treatment work in everyday practice?' rather than 'Can this treatment work under ideal circumstances?' The distinction between pragmatic and explanatory trials was formally articulated by Schwartz and Lellouch in 1967 and operationalized by the PRECIS tool in 2009.