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Cost-Effectiveness Analysis Alongside Clinical Trials II—An ISPOR Good Research Practices Task Force Report

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Ramsey, Scott D., Willke, Richard J., Glick, Henry, Reed, Shelby D., Augustovski, Federico, Jonsson, Bengt, Briggs, Andrew, Sullivan, Sean D.·2015·Value in Health

DOI 10.1016/j.jval.2015.02.001

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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.

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Sullivan, 2001, Design and analytic considerations in determining the cost-effectiveness of early intervention in asthma from a multinational clinical trial, Control Clin Trials, 22, 420, 10.1016/S0197-2456(01)00137-4 · DOI
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Consolidated Health Economic Evaluation Reporting Standards (CHEERS) 2022 Explanation and Elaboration: A Report of the ISPOR CHEERS II Good Practices Task Force
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Consolidated Health Economic Evaluation Reporting Standards 2022 (CHEERS 2022) statement: updated reporting guidance for health economic evaluations
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Authors: Ramsey, S. D., Willke, R. J., Glick, H., Reed, S. D., Augustovski, F., Jonsson, B., Briggs, A., & Sullivan, S. D.
Affiliations: University of Washington (US)
Pfizer (United States) (US)
University of Pennsylvania (US)
Duke University (US)
Universidad de Buenos Aires (AR)
University of Glasgow (GB)
Corresponding author: Ramsey, Scott D.
ORCID: Ramsey, Scott D.
Willke, Richard J.
Reed, Shelby D.
Augustovski, Federico
Briggs, Andrew
Sullivan, Sean D.
Venue: Value in Health
Publisher: Elsevier BV
Published: 2015-03
Volume: 18
Issue: 2
Pages: 161-172
ISSN: 1098-3015 (ISSN-L)
DOI: 10.1016/j.jval.2015.02.001
OpenAlex: W2139814250
Cited by: 811
References: 184
Citations by year: 2026: 58 · 2025: 75 · 2024: 90 · 2023: 80 · 2022: 100 · 2021: 103 · 2020: 88 · 2019: 65 · 2018: 50 · 2017: 57 · 2016: 37 · 2015: 6
FWCI: 17.59
Type: journal article
Language: en
Open access: bronze
doi.org
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
www.elsevier.com/open-access/userlicense/1.0/ (vor, 366 d)
Locations: Value in Health (publishedVersion)
PubMed (publishedVersion)
ENLIGHTEN (Jurnal Bimbingan dan Konseling Islam) (submittedVersion)
Topics: Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Health Systems, Economic Evaluations, Quality of Life
Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Economic and Environmental Valuation
Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Pharmaceutical Economics and Policy
Keywords: cost-effectiveness analysis, clinical trials, economic evaluation, trial design, health care utilization, health utility, intention-to-treat analysis, subgroup analysis, uncertainty characterization, reporting guidelines, reimbursement decisions, healthcare resource allocation
MeSH terms: Cost-Benefit Analysis, Health Policy, Health Services Research, Humans, Randomized Controlled Trials as Topic, Advisory Committees, Research Report

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Cost-Effectiveness Analysis Alongside Clinical Trials II—An ISPOR Good Research Practices Task Force Report

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