Factors to Consider When Designing Phase III Clinical Trials Involving Economic Evaluations

• Published in: Perceptual and motor skills Vol. 89; no. 3_suppl; pp. 1059 - 1072
• Main Authors: Van Enckevort, Petra J., TenVergert, Elisabeth M., Kingma, Johannes, Koëter, Gerard H., Rutten, Frans F. H.
• Format: Journal Article
• Language: English
• Published: Los Angeles, CA SAGE Publications 01.12.1999; SAGE PUBLICATIONS, INC
• Subjects: Clinical trials; Clinical Trials, Phase III as Topic - economics; Cost analysis; Cost-Benefit Analysis; Economics; Humans; Outcome Assessment (Health Care); Patient Selection; Randomized Controlled Trials as Topic - economics; Research Design - standards; Research Design - statistics & numerical data
• ISSN: 0031-5125; 1558-688X
• DOI: 10.2466/pms.1999.89.3f.1059

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.