title: [Study designs for the evaluation of drug effects].
abstract: Randomized controlled trials (RCTs) have been considered the reference standard for evaluation of drug effects. Controversy exists concerning observational studies because of the lack of blinding and the risk of uncontrolled confounding. However, RCTs also have limitations, including short follow-up and relatively small study populations, which make it impossible to examine rare events and cross-over problems. None of the designs provides perfect information and both designs are needed in the evaluation of drug effects.
authors.affiliation: Klinisk Epidemiologisk Afdeling, Arhus Universitetshospital, Aalborg Sygehus, DK-8200 Arhus N. sc@dce.au.dk
authors.forename: Steffen
authors.initials: S
authors.lastname: Christensen
authors.forename: Christian Fynbo
authors.initials: CF
authors.lastname: Christiansen
authors.forename: Henrik Toft
authors.initials: HT
authors.lastname: Sørensen
mesh_terms: D004341:Drug Evaluation / Q000379:methods* / Q000592:standards; D064420:Drug-Related Side Effects and Adverse Reactions; D019317:Evidence-Based Medicine; D006801:Humans; D019370:Observation / Q000379:methods; D004364:Pharmaceutical Preparations / Q000008:administration & dosage; D016032:Randomized Controlled Trials as Topic / Q000379:methods* / Q000592:standards
chemical_list: D004364:Pharmaceutical Preparations