Methoden vergelijken

	Multicenter Fase I Klinische Studie	Multicenter Randomized Clinical Trial
Vakgebied	Epidemiologie	Epidemiologie
Familie	Process / pipeline	Process / pipeline
Jaar van ontstaan	1970s–1980s (formalized in FDA Phase I guidance 1977; ICH E6 GCP 1996)	1970s–1980s (widespread adoption for large-scale efficacy trials)
Grondlegger	Established through FDA regulatory guidance and ICH harmonization frameworks	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
Type	Interventional clinical study design	Interventional experimental design
Oorspronkelijke bron	International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). (2016). ICH Harmonised Guideline: Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2). ICH.	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
Aliassen	multisite Phase I trial, multi-institutional Phase I study, Phase I dose-escalation multicenter study, first-in-human multicenter trial	multi-site RCT, multicenter RCT, multinational randomized trial, multicenter controlled trial
Verwant	6	6
Samenvatting	A multicenter Phase I clinical trial is the first systematic administration of an investigational agent to humans, conducted simultaneously across two or more clinical sites. Its primary objectives are to characterize the safety and tolerability profile of the intervention, determine the maximum tolerated dose (MTD), and describe pharmacokinetic and pharmacodynamic behavior. Distributing enrollment across sites increases participant accrual speed and enhances the generalizability of early-phase safety data.	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.