title: Factors to consider when designing phase III clinical trials involving economic evaluations.
abstract: Given the recognized need to examine cost-effectiveness data in addition to clinical data when making decisions relating to choice of clinical interventions, there is a growing interest and experience in undertaking economic evaluations alongside clinical trials. It has been argued, when an economic evaluation is necessary for assessing the cost-effectiveness of a medical intervention, the integration of both the medical and clinical issues need to be included at the start of designing a clinical trial. A proposal has been made for how clinical researchers and health economists may cooperate successfully at the successive phases in designing a clinical trial. Therefore, discussion points for clinical researchers and health economists are given, and the possible methodological consequences of adding an economic evaluation to a trial are addressed.
authors.affiliation: Office for Medical Technology Assessment, University Hospital Groningen, The Netherlands.
authors.forename: P J
authors.initials: PJ
authors.lastname: van Enckevort
authors.forename: E M
authors.initials: EM
authors.lastname: TenVergert
authors.forename: J
authors.initials: J
authors.lastname: Kingma
authors.forename: G H
authors.initials: GH
authors.lastname: Koëter
authors.forename: F F
authors.initials: FF
authors.lastname: Rutten
mesh_terms: D017326:Clinical Trials, Phase III as Topic / Q000191:economics*; D003362:Cost-Benefit Analysis; D006801:Humans; D017063:Outcome Assessment, Health Care; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic / Q000191:economics; D012107:Research Design / Q000592:standards / Q000706:statistics & numerical data