The DOI matches its Crossref record; 183 of the 184 references it cites were found in a registry or an index.
Cost-Effectiveness Analysis Alongside Clinical Trials II—An ISPOR Good Research Practices Task Force Report
Open accessAbstract
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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“The economic evaluation will be performed from a societal perspective, and all analyses will be conducted according to the intention-to-treat principle, in which we adhere to the related guidelines [67–69].”
In the citing paper
“For example, parameter uncertainty will be covered by, for example, sensitivity analyses in which imputed uncertainty is also taken into account by repeating the economic evaluation on the imputed dataset and sampling uncertainty will be taken into account by providing a cost-effectiveness acceptability curve and frontier [67].”
In the citing paper
“Best practice within-trial economic evaluation methods will be adopted53”
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Self-citationLi, Y., Reed, S. D., Winger, J. G., Kelleher, S. A., Fisher, H. M., Zullig, L. L., & Somers, T. J. (2026) · Palliative & Supportive Care · doi:10.1017/s1478951526103393
“Our analysis based on observed patient-level data collected within the ICAN NC trial allows us to avoid such assumptions (Ramsey et al. 2015).”
Self-citationStearns, S. C., Weintraub, J. A., Preisser, J. S., Ward, K. T., Wretman, C. J., Sloane, P. D., & Zimmerman, S. I. (2026) · Nursing Reports · doi:10.3390/nursrep16090330
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do Nascimento, R. G., SILVA, V. F. D., Baggio, L., Cerqueira, D. D. O., Souza, B., & de Souza, D. A. (2026) · Springer eBooks · doi:10.1007/978-3-032-34578-3_5
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“For the purposes of comparative analyses, the alternatives being compared are new (or innovative) technologies, products, or processes versus the closest alternatives in terms of results or efficacy (Ramsey et al. 2015).”
Metadata
- 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
- Venue
- Value in Health
- Publisher
- Elsevier BV
- Published
- 2015-03
- Volume
- 18
- Issue
- 2
- Pages
- 161-172
- ISSN
- 1098-3015 (ISSN-L)
- 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
- 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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