Abstract

The International Society for Pharmacoeconomics and Outcomes Research Randomized Clinical Trials- Cost-Effectiveness Analysis Task Force (hereafter referred to as the TF) has undertaken the challenging task of preparing and issuing a good research practices guidance document pertaining to cost-effectiveness analysis alongside clinical trials. Specifically, the TF members provide guidance on various aspects of the design, conduct, and reporting of such studies. Their primary motivation is to promote improvement in the quality of both the conduct and reporting of trial-based cost-effectiveness analyses thereby enhancing the credibility of these studies in the eyes of decision makers. Notable contributions of the report include the citation of an extensive literature, guidance on reporting methods and results, and a table of 27 core recommendations agreed by all the TF members. The report highlights just how far our knowledge, experience, and methods, particularly analysis, have developed since the pioneering days of conducting economic evaluation through the vehicle of randomized controlled trials.