Published Oct 2005
Citation
Ramsey SD, Wilke RJ, Briggs AH, et al. Good research practices for cost-effectiveness analysis alongside clinical trials: the ISPOR RCT-CEA Task Force Report. Value Health. 2005; 8(5):521-533.
Abstract
Objectives: A growing number of prospective clinical trials
include economic end points. Recognizing the variation
in methodology and reporting of these studies, the
International Society for Pharmacoeconomics and Outcomes
Research (ISPOR) chartered the Task Force on
Good Research Practices: Randomized Clinical Trials—
Cost-Effectiveness Analysis. Its goal was to develop a
guidance document for designing, conducting, and reporting
cost-effectiveness analyses conducted as a part of clinical
trials.
Methods: Task force cochairs were selected by the ISPOR
Board of Directors. Cochairs invited panel members to
participate. Panel members included representatives from
academia, the pharmaceutical industry, and health insurance
plans. An outline and a draft report developed by the
panel were presented at the 2004 International and
European ISPOR meetings, respectively. The manuscript
was then submitted to a reference group for review and
comment.
Results: The report addresses issues related to trial
design, selecting data elements, database design and management,
analysis, and reporting of results. Task force
members agreed that trials should be designed to evaluate
effectiveness (rather than efficacy), should include clinical
outcome measures, and should obtain health resource use
and health state utilities directly from study subjects. Collection
of economic data should be fully integrated into
the study. Analyses should be guided by an analysis plan
and hypotheses. An incremental analysis should be conducted
with an intention-to-treat approach. Uncertainty
should be characterized. Manuscripts should adhere to
established standards for reporting results of costeffectiveness
analyses.
Conclusions: Trial-based cost-effectiveness studies have
appeal because of their high internal validity and timeliness.
Improving the quality and uniformity of these studies
will increase their value to decision makers who
consider evidence of economic value along with clinical
efficacy when making resource allocation decisions.
Keywords: cost-effectiveness, economic, guidelines, randomized
clinical trial.
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