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Value Health. 2015 Mar;18(2):161-72. doi: 10.1016/j.jval.2015.02.001.

Cost-effectiveness analysis alongside clinical trials II-An ISPOR Good Research Practices Task Force report.

Author information

1
Hutchinson Institute for Cancer Outcomes Research, Fred Hutchinson Cancer Research Center, Seattle, WA, USA; Schools of Medicine and Pharmacy, University of Washington, Seattle, WA, USA. Electronic address: sramsey@fredhutch.org.
2
Outcomes & Evidence Lead, CV/Metabolic, Pain, Urology, Gender Health, Global Health & Value, Pfizer, Inc., New York, NY, USA.
3
Division of General Internal Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
4
Duke Clinical Research Institute, Duke University, Durham, NC, USA.
5
Institute for Clinical Effectiveness and Health Policy (IECS), University of Buenos Aires, Buenos Aires, Argentina.
6
Department of Economics, Stockholm School of Economics, Stockholm, Sweden.
7
William R. Lindsay Chair of Health Economics, University of Glasgow, Glasgow, Scotland, UK.
8
Hutchinson Institute for Cancer Outcomes Research, Fred Hutchinson Cancer Research Center, Seattle, WA, USA; Schools of Medicine and Pharmacy, University of Washington, Seattle, WA, USA.

Abstract

Clinical trials evaluating medicines, medical devices, and procedures now commonly assess the economic value of these interventions. The growing number of prospective clinical/economic trials reflects both widespread interest in economic information for new technologies and the regulatory and reimbursement requirements of many countries that now consider evidence of economic value along with clinical efficacy. As decision makers increasingly demand evidence of economic value for health care interventions, conducting high-quality economic analyses alongside clinical studies is desirable because they broaden the scope of information available on a particular intervention, and can efficiently provide timely information with high internal and, when designed and analyzed properly, reasonable external validity. In 2005, ISPOR published the Good Research Practices for Cost-Effectiveness Analysis Alongside Clinical Trials: The ISPOR RCT-CEA Task Force report. ISPOR initiated an update of the report in 2014 to include the methodological developments over the last 9 years. This report provides updated recommendations reflecting advances in several areas related to trial design, selecting data elements, database design and management, analysis, and reporting of results. Task force members note that trials should be designed to evaluate effectiveness (rather than efficacy) when possible, 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. An incremental analysis should be conducted with an intention-to-treat approach, complemented by relevant subgroup analyses. Uncertainty should be characterized. Articles should adhere to established standards for reporting results of cost-effectiveness analyses. Economic studies alongside trials are complementary to other evaluations (e.g., modeling studies) as information for decision makers who consider evidence of economic value along with clinical efficacy when making resource allocation decisions.

KEYWORDS:

clinical trial; cost-effectiveness; economic; guidelines

PMID:
25773551
DOI:
10.1016/j.jval.2015.02.001
[Indexed for MEDLINE]
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