Good Research Practices for Cost-Effectiveness Analysis Alongside Clinical Trials: The ISPOR RCT-CEA Task Force Report

The citation for this report is:
Ramsey, Scott, Willke, Richard, Briggs, Andrew, Brown, Ruth, Buxton, Martin, Chawla, Anita, Cook, John, Glick, Henry, Liljas, Bengt, Petitti, Diana & Reed, Shelby (2005) Good Research Practices for Cost-Effectiveness Analysis Alongside Clinical Trials: The ISPOR RCT-CEA Task Force Report.
Value in Health 2005; 8: 521-533.

Task Force Co-Chairs
Scott Ramsey MD, PhD, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA
Richard Willke PhD, Pfizer, Inc., Bridgewater, NJ, USA

Leadership Group:
Andrew Briggs DPhil, University of Oxford, Health Economics Research Center, Headington, Oxford, UK
Ruth Brown MS, MEDTAP International, London, UK
Martin Buxton PhD, Brunel University, Uxbridge, Middlesex, UK
Anita Chawla PhD, Genentech, San Francisco, CA, USA
John Cook PhD, Merck Research Laboratories, Blue Bell, PA, USA
Henry Glick PhD, University of Pennsylvania, Division of Internal Medicine, Philadelphia, PA, USA
Bengt Liljas PhD, AstraZeneca, Lund, Sweden
Diana Petitti MD, Kaiser Permanente, Pasadena, CA, USA
Shelby Reed PhD, Duke Clinical Research Institute, Durham, NC, USA

ABSTRACT

Objectives: A growing number of prospective clinical trials include economic endpoints. Recognizing the variation in methodology and reporting of these studies, ISPOR chartered a 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 of cost-effectiveness analysis conducted as a part of clinical trials.

Methods: Task Force co-chairs were selected by the ISPOR Board of Directors. Co-chairs invited panel members to participate. Panel members included representatives from academia, the pharmaceutical industry, and health insurance plans. An outline and 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. Economic data collection should be fully integrated into the study. Analyses should be guided by an analysis plan and hypotheses. An incremental analysis should be conducted using an intention to treat approach.  Uncertainty should be characterized. Manuscripts should adhere to established standards for reporting results of cost-effectiveness analyses

Conclusions: Trial-based cost-effectiveness studies have appeal due to 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.

ISPOR GOOD RESEARCH PRACTICES INDEX

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