Factors to consider when designing phase III clinical trials involving economic evaluations

Percept Mot Skills. 1999 Dec;89(3 Pt 2):1059-72. doi: 10.2466/pms.1999.89.3f.1059.

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.

Publication types

  • Review

MeSH terms

  • Clinical Trials, Phase III as Topic / economics*
  • Cost-Benefit Analysis
  • Humans
  • Outcome Assessment, Health Care
  • Patient Selection
  • Randomized Controlled Trials as Topic / economics
  • Research Design / standards
  • Research Design / statistics & numerical data