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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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“Следователно общоприетият методологичен подход е резултатите от икономическия анализ да бъдат представени като инкрементално съотношение (ICER) на допълнителни разходи (Δ costs) и допълнителни здравни ползи (Δ QALY) на алтернативните здравни технологии за профилактика и лечение на възрастни CMV-серопозитивни пациенти…”
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Ribeiro, I., Marques, F. B., Alves, D., & Alves, C. (2020) · Acta Ophthalmologica · doi:10.1111/aos.14362
“Additionally, it can be applied to both trialbased and model-based economic evaluation studies and it is the checklist recommended by the Campbell & Cochrane Economics Methods Group (Wijnen et al. 2016; Ribeiro et al. 2019).”
Method
Economic Evaluation of Pharmaceuticals
Ademi, Z., Marquina, C., & Liew, D. (2026) · Elsevier eBooks · doi:10.1016/b978-0-443-26472-6.00159-5
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“In addition, it is recommended that you consult your country’s guidelines to identify when there is a preferred valuation approach (ISPOR, 2019).”
BackgroundMethodInfluential
O selamento é uma alternativa as restaurações para lesões de cárie moderada na superfície oclusal de dentes decíduos?
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Ibekwe, E. (2026) · e-space (Manchester Metropolitan University) · doi:10.83056/mmu.32477667
Dumb and Dumberer When Harry Met Lloyd (Film)
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“…Sakamaki et al., 2020; Thiers, Sinskey, & Berndt, 2008), including in Latvia (Logviss, Krievins, & Purvina, 2018), but various economic aspects of clinical trials are subject to continuous changes (Kramer, J. M.;Schulman, 2012; Petitti, 2009; Pinto, Willan, & O’Brien, 2005; Ramsey et al., 2015).”
Background
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“…Evaluation of Health Care Programmes (Drummond et al., 2015), taking into account the CHEERS statement (Husereau et al., 2013) and the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) guidelines on economic evaluations alongside clinical trials (Ramsey et al., 2015).”
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Torreglosa, C. R., Sarti, F. M., Ferreira, Â. C. B., Weber, B., Santos, R. H. N., Silvestrini, M. M., & Filho, A. D. P. C. (2020) · doi:10.21203/rs.3.rs-27302/v1
“The guidelines for economic evaluations of clinical trials recommend considering intention-to-treat analyses (datasets from the original trial) to perform cost-effectiveness analysis(32).”
Background
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Muresan, B. (2023) · doi:10.33612/diss.568330158
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Veje, P. L. (2022) · doi:10.54337/aau517402491
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Matthijssen, S. J. M. A., Lee, C. W., de Roos, C., Barron, I. G., Jarero, I., Shapiro, E., Hurley, E. C., Schubert, S. J., Baptist, J. A., Amann, B. L., et al. (2023) · Journal of EMDR Practice and Research · doi:10.1891/emdr-2023-0012
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Harper, D. M., Anderson, R. J., Baker, E., & Yu, T. M. (2023) · doi:10.1158/1940-6207.c.6709342.v1
Data from Cost-effectiveness of p16/Ki-67 Dual-Stained Cytology Reflex Following Co-testing with hrHPV Genotyping for Cervical Cancer Screening
Harper, D. M., Anderson, R. J., Baker, E., & Yu, T. M. (2023) · doi:10.1158/1940-6207.c.6709342
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Pirhonen, L., McAuliffe, F. M., Maindal, H. T., O'Reilly, S. L., Davies, A. K., Burden, C., Skinner, T. C., Vrangbæk, K., & Callander, E. J. (2023) · Research Square · doi:10.21203/rs.3.rs-3302819/v1
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Berghuis, A. M. S., Koffijberg, H., Pouwels, X., Berger, F., Alix‐Panabières, C., Jacot, W., Pierga, J., Bidard, F., & IJzerman, M. J. (2023) · medRxiv · doi:10.1101/2023.10.09.23296711
“The analysis of cost-effectiveness is critical to support translation and reimbursement of new technologies deemed effective and empirical cost-effectiveness analysis based on data collected alongside a clinical trial are strongly recommended (21).”
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Managing high cardiovascular disease risk among adults in Argentina using a multicomponent strategy linking key aspects of care: A two-arm cluster-randomized clinical trial (PRIMECare) protocol
Abrahams‐Gessel, S., Beratarrechea, A. G., Irazola, V. E., Gulayin, P., Gutiérrez, L., Mahoney, M., & Gaziano, T. A. (2023) · Contemporary Clinical Trials · doi:10.1016/j.cct.2023.107357
Economic Evaluation of Mental Health Interventions
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Análise do custo-utilidade de uma tecnologia de reabilitação para tratamento e prevenção de disfunções musculoesqueléticas em pés e tornozelos de pessoas com diabetes mellitus: ensaio clínico randomizado FOotCAre (FOCA)
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Telemonitoring in Heart Failure Patient Management
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Economic evaluation of preventive cognitive therapy versus care as usual in cognitive behavioral therapy responders
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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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