Factors to consider when designing phase III clinical trials involving economic evaluations.
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.
van Enckevort
P J
PJ
Office for Medical Technology Assessment, University Hospital Groningen, The Netherlands.
TenVergert
E M
EM
Kingma
J
J
Koëter
G H
GH
Rutten
F F
FF
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