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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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Background
Methodological Comparison of Mapping the Expanded Prostate Cancer Index Composite to EuroQoL-5D-3L Using Cross-Sectional and Longitudinal Data: Secondary Analysis of NRG/RTOG 0415
Khairnar, R. R., DeMora, L., Sandler, H. M., Lee, W. R., Villalonga-Olives, E., Mullins, C. D., Palumbo, F. B., Bruner, D. W., Shaya, F. T., Bentzen, S. M., et al. (2022) · JCO Clinical Cancer Informatics · doi:10.1200/cci.21.00188 · Cited by 2
Safer Baby Bundle: study protocol for the economic evaluation of a quality improvement initiative to reduce stillbirths
Callander, E. J., Andrews, C. J., Sketcher‐Baker, K. M., Nicholl, M., Farrell, T., Karger, S., & Flenady, V. (2022) · BMJ Open · doi:10.1136/bmjopen-2021-058988 · Cited by 2
Direct Medical Costs and Healthcare Resource Utilization of Treating Patients With Two Clinical Subtypes of Axial Spondyloarthritis in Colombia.
Santos-Moreno, P., Parra-Padilla, D., la Rosa, F. G.-D., Carrasquilla-Sotomayor, M., Villarreal, L., Jervis-Jálabe, D. S., & Alvis-Zakzuk, N. (2022) · Value in Health Regional Issues · doi:10.1016/j.vhri.2022.08.003 · Cited by 3
Cost-effectiveness of monthly follow-up for the treatment of uncomplicated severe acute malnutrition: An economic evaluation of a randomized controlled trial
Menzies, N. A., Berthé, F., Hitchings, M. D. T., Aruna, P., Hamza, M. A., Nanama, S., Steve-Edemba, C., Shehu, I., Grais, R. F., & Isanaka, S. (2022) · PLOS Global Public Health · doi:10.1371/journal.pgph.0001189 · Cited by 2
How Much Better is Faster? Value Adjustments for Health-Improvement Sequences
Johnson, F. R., González, J. M., Sheehan, J. J., & Reed, S. D. (2023) · PharmacoEconomics · doi:10.1007/s40273-023-01266-7 · Cited by 2
“Some authors have suggested that HSUs should be estimated to detect treatment effects over shorter time intervals [35].”
BackgroundSelf-citation
Valuing quality of life for economic evaluations in cancer: navigating multiple methods
Ng, C., Lourenço, R. D. A., Viney, R. C., Norman, R., King, M. T., Kim, N. V., & Mulhern, B. J. (2024) · Expert Review of Pharmacoeconomics & Outcomes Research · doi:10.1080/14737167.2024.2393332 · Cited by 2
“The growing prevalence and cost of chronic progressive diseases, including cancer, has also led to more economic evaluations based on a combination of clinical trials and real-world data [80].”
Cost-effectiveness of bioimpedance-guided fluid management in patients undergoing haemodialysis: the BISTRO RCT
Zanganeh, M., Belcher, J., Fotheringham, J., Coyle, D., Lindley, E. J., Keane, D. F., Caskey, F. J., Dasgupta, I., Davenport, A., Farrington, K., et al. (2024) · Health Technology Assessment · doi:10.3310/jypr4287 · Cited by 2
“23,45,51 Despite these strengths, this study has certain limitations.”
Background
Modernizing Newborn Screening in the Genomic Era: Importance of Health-Related Quality of Life
Kim, E., Wu, A. C., Christensen, K. D., Wright, D. R., Yeh, J. M., & Smith, H. S. (2024) · PharmacoEconomics - Open · doi:10.1007/s41669-024-00528-0 · Cited by 2
“Another approach is to integrate health economic and outcomes working groups into prospective trials and pilot newborn screening programs [55].”
Background
Benzodiazepine agonist treatment for patients with benzodiazepine dependence undergoing opioid agonist treatment: a study protocol for the randomized controlled trial BMX-BAR
Chalabianloo, F., Fadnes, L. T., Aßmus, J., Mordal, J., Solli, K. K., Dale, K. S., Andersen, C. D., Zavenova, S., Rønning, B. H., Blomkvist, A. W., et al. (2025) · Trials · doi:10.1186/s13063-024-08692-8 · Cited by 2
“The analysis will follow the current guidelines and will be conducted by a health economist [30].”
Cost-effectiveness of direct oral anticoagulants in non-valvular atrial fibrillation
Gorostiza, I., Bilbao‐González, A., & Mar, J. (2025) · Gaceta Sanitaria · doi:10.1016/j.gaceta.2025.102451 · Cited by 2
Luteinizing hormone-based modified GnRH antagonist protocol in normal responders undergoing in vitro fertilization treatment: A multi-center randomized controlled trial
Liu, S., Lv, Y.-S., Liu, M., Han, S., Liu, X., Zhao, Z., Cui, W., Yang, A., & Li, Y. (2022) · Frontiers in Endocrinology · doi:10.3389/fendo.2022.922950 · Cited by 2
“Even when the primary outcome was similar (as was the case in this study), costeffectiveness analysis should be performed to assess the effectiveness rather than the efficacy of the procedure (25).”
Result
Cost‐effectiveness of web‐based therapy: what's it worth?
Kerr, C. (2017) · Developmental Medicine & Child Neurology · doi:10.1111/dmcn.13441 · Cited by 2
“Healthcare systems require evidence of clinical effectiveness and economic value to satisfy regulatory and reimbursement requirements.(1) Estimates of value for money of a particular medicine, procedure, or therapeutic intervention are of relevance to all healthcare clients: governments, insurers, service providers, d…”
Background
Rationale and protocol for estimating the economic value of a multicomponent quality improvement strategy for diabetes care in South Asia
On behalf of the CARRS Trial Group, Singh, K., Ali, M. K., Devarajan, R., Shivashankar, R., Kondal, D., Ajay, V. S., Menon, V. U., Varthakavi, P. K., Viswanathan, V., et al. (2019) · Global Health Research and Policy · doi:10.1186/s41256-019-0099-x · Cited by 2
Emerging role of pharmacoeconomics into clinical trials and its outcomes: An overview
Biswkarma, V. K., & Wadhawan, S. (2020) · Indian Journal of Pharmacy and Pharmacology · doi:10.18231/j.ijpp.2020.014 · Cited by 2
Can Cost-effectiveness Analysis Inform Genotype-Guided Aspirin Use for Primary Colorectal Cancer Prevention?
Biltaji, E., Walker, B. S., Au, T. H., Rivers, Z. T., Ose, J., Li, C. I., Brixner, D. I., Stenehjem, D. D., & Ulrich, C. M. (2021) · Cancer Epidemiology Biomarkers & Prevention · doi:10.1158/1055-9965.epi-19-1580 · Cited by 2
Sample size calculation for recurrent event data with additive rates models
Zhu, L., Li, Y., Tang, Y., Shen, L., Onar‐Thomas, A., & Sun, J. (2021) · Pharmaceutical Statistics · doi:10.1002/pst.2154 · Cited by 2
Cost-effectiveness of oral versus intravenous antibiotics (OVIVA) in patients with bone and joint infection: evidence from a non-inferiority trial
McMeekin, N., Geue, C., Briggs, A. H., Rombach, I., Li, H. K., Bejon, P., McNally, M., Atkins, B. L., Ferguson, J. Y., Scarborough, M., et al. (2019) · Wellcome Open Research · doi:10.12688/wellcomeopenres.15314.2 · Cited by 2
Self-citation
Cost-effectiveness of oral versus intravenous antibiotics (OVIVA) in patients with bone and joint infection: evidence from a non-inferiority trial
McMeekin, N., Geue, C., Briggs, A. H., Rombach, I., Li, H. K., Bejon, P., McNally, M., Atkins, B. L., Ferguson, J. Y., Scarborough, M., et al. (2019) · Wellcome Open Research · doi:10.12688/wellcomeopenres.15314.1 · Cited by 2
Self-citation
Few More Lessons Learnt from Covid-19: Health Technology Assessment (HTA) Perspective
Khan, I. A., & Malik, N. (2022) · National Journal of Community Medicine · doi:10.55489/njcm.130820222103 · Cited by 2
A protocol for a cluster randomized trial of care delivery models to improve the quality of smoking cessation and shared decision making for lung cancer screening
Lowenstein, L. M., Shih, Y. T., Minnix, J. A., Lopez-Olivo, M. A., Maki, K. G., Kypriotakis, G., Leal, V. B., Shete, S. S., Fox, J., Nishi, S. P. E., et al. (2023) · Contemporary Clinical Trials · doi:10.1016/j.cct.2023.107141 · Cited by 2
A review of heath economic evaluation practice in the Netherlands: are we moving forward?
Gabrio, A. (2023) · Health Economics Policy and Law · doi:10.1017/s1744133123000087 · Cited by 2
“Given the intrinsic complexity that characterise the analysis framework of health economic data, the choice of the analytical approaches to deal with these problems as well as transparent information on their implementation is crucial in determining the degree of confidence that decision-makers should have towards cos…”
Background
Comparative effectiveness of digital mental healthcare models for adults with epilepsy: A study protocol of a randomized controlled trial
Gandy, M., Coleman, H., Cutler, H., Jones, M., Karin, E., Kwan, P., Nikpour, A., Parratt, K. L., Rayner, G., Titov, N., et al. (2024) · Epilepsia Open · doi:10.1002/epi4.12913 · Cited by 2
Stimulation Therapy to Induce Mothers: Protocol for a Multicenter Randomized Controlled Trial
Tortal, D., Shabanova, V., Taylor, S., Xu, X., McAdow, M., Stetson, B., McCollum, S., Sanchez, E., Adjakple, A., Leventhal, J., et al. (2024) · JMIR Research Protocols · doi:10.2196/63463 · Cited by 2
“EQ-5D is a recommended and widely used instrument for measuring utility scores in clinical trials and in maternal health research [64,65].”
Method
Economic evaluation plan of a randomised controlled trial of intra-nodular injection of anti-TNF and placebo among patients with early Dupuytren’s disease: Repurposing Anti-TNF for Treating Dupuytren’s Disease (RIDD)
Png, M. E., Dritsaki, M., Gray, A. M., Pinedo‐Villanueva, R., Rivero‐Arias, O., & Nanchahal, J. (2019) · Wellcome Open Research · doi:10.12688/wellcomeopenres.14936.2 · Cited by 2
Health technology assessment of hyperphosphatemia management among hemodialysis patients in Lebanon
Rizk (2017) · doi:10.26481/dis.20170622rr · Cited by 2
“For instance, in the US in 2014, more than $26 billion were spent on hemodialysis patients ($87,638 per patient per year, in comparison with $73,612 for peritoneal dialysis and $32,586 for renal transplantation) [70].”
Background
Optimality, Future and Terminal Costs: Comment on “Adjuvant Trastuzumab Therapy for Early HER2-Positive Breast Cancer in Iran”
Gershon, N., & Berchenko, Y. (2018) · PharmacoEconomics · doi:10.1007/s40273-018-0621-x · Cited by 2
“Currently, despite strong arguments in favor of including future costs [2], there are still conflicting guidelines [3, 4], and the vast majority of CEAs we reviewed did not consider future costs.”
Background
A cost-effectiveness analysis of a silicone film-forming gel versus 10% glycerine in patients with head and neck cancer
Blades, R. (2020) · Queensland University of Technology · doi:10.5204/thesis.eprints.198193 · Cited by 2
Development of a Cost of Illness Inventory Questionnaire for Children With Autism Spectrum Disorder in South AsiaPreprint
Chaudhary, D., Bhat, B., Shields, G., Davies, L. M., Green, J., Verghis, T., Roy, R., Kumar, D., Abhilashi, M. K., Vajaratkar, V. P., et al. (2021) · Research Square · doi:10.21203/rs.3.rs-966313/v1 · Cited by 2
Erratum to: Short Term Economic Evaluation of the Digital Platform “Support, Monitoring and Reminder Technology for Mild Dementia” (SMART4MD) for People with Mild Cognitive Impairment and Their Informal Caregivers
Ghani, Z., Saha, S., Jarl, J., Andersson, M., Berglund, J. S., & Anderberg, P. (2024) · Journal of Alzheimer s Disease · doi:10.3233/jad-249009 · Cited by 2
Minimizing the Cost in Sample Size Computation
Luo, J. (2016) · Austin Biometrics and Biostatistics · doi:10.26420/austinbiomandbiostat.2016.1031 · Cited by 1
“There are a lot of publications about cost-effectiveness-design (see [6,7] and accompanying references), but our approaches are totally different from them since we focus on sample size allocation at the design stage.”
Background
Cost-effectiveness of a complex intervention in general practice to increase uptake of long-acting reversible contraceptives in Australia†
Lewandowska, M., Lourenço, R. D. A., Haas, M., Watson, C. J., Black, K. I., Taft, A., Lucke, J. C., McGeechan, K., McNamee, K., Peipert, J. F., et al. (2021) · Australian Health Review · doi:10.1071/ah20282 · Cited by 1
Economic Evaluation of Using Daily Prednisolone versus Placebo at the Time of an Upper Respiratory Tract Infection for the Management of Children with Steroid-Sensitive Nephrotic Syndrome: A Model-Based Analysis
Afentou, N., Frew, E. J., Mehta, S. P., Ives, N. J., Woolley, R. L., Brettell, E. A., Khan, A. R., Milford, D. V., Böckenhauer, D., Saleem, M. A., et al. (2022) · PharmacoEconomics - Open · doi:10.1007/s41669-022-00334-6 · Cited by 1
“Unlike clinical-effectiveness analysis, which is based on the concept of classic statistical inference, economic evaluation is about decision analysis and is recommended by International Society for Pharmacoeconomics and Outcomes Research (ISPOR) guidance for trials that report a non-statistically significant differen…”
Method
Strategies for cost-effectiveness analysis of rehabilitation for older patients with acute heart failure
Sakai, K., Momosaki, R., & Hoshino, E. (2022) · Cost Effectiveness and Resource Allocation · doi:10.1186/s12962-022-00387-8 · Cited by 1
“To ensure external validity, a comparator should represent best or common practice [11].”
Background
The Cost-Effectiveness of Chin Tuck Against Resistance Compared to Usual Care in Citizens with Oropharyngeal Dysphagia – An Economic Evaluation
Dyreborg, L., Raunbak, S. M., Sørensen, S. S., Melgaard, D., & Westmark, S. (2023) · ClinicoEconomics and Outcomes Research · doi:10.2147/ceor.s431380 · Cited by 1
“The economic evaluation followed the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) guideline for conducting health economic evaluations alongside clinical trials 21 and the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) for economic evaluations.”
Method
Health service and medication costs associated with common mental disorders and subthreshold symptoms in women: Findings from the Geelong Osteoporosis Study in Australia
Chatterton, M. L., Faller, J., Le, L. K., Engel, L., Williams, L. J., Pasco, J. A., & Mihalopoulos, C. (2024) · Australian & New Zealand Journal of Psychiatry · doi:10.1177/00048674241229931 · Cited by 1
“A gamma error distribution with a logarithmic link function in the GLM was used due to the skewed distribution of cost data consistent with the International Society for Pharmacoeconomics and Outcome Research guidelines (Ramsey et al., 2015).”
Method
The IMPROVE trial: study protocol for a pragmatic cluster randomised controlled trial to assess the effectiveness of using lay health workers to improve uptake and completion of pulmonary rehabilitation in patients with chronic obstructive pulmonary disease
Gilworth, G., Harris, K., Morgan, T., Ayis, S. A., Fox-Rushby, J. A., Godfrey, E. L., Hopkinson, N. S., Lewin, S. A., Lim, K. K., Spinou, A., et al. (2024) · Trials · doi:10.1186/s13063-024-07998-x · Cited by 2
“These economic evaluations will adopt the viewpoints of NHS and personal social services as well as that of society and be developed based on guidance for good practice, and decision support for NICE [40, 41].”
Background
Screening, brief intervention, and referral to treatment for pain management for veterans separating from military service: study protocol of a hybrid type 2 study testing implementation facilitation versus training-as-usual
Sellinger, J. J., Rosen, M. I., Lazar, C. M., Gilstad‐Hayden, K., Dziura, J. D., Li, F., Mattocks, K. M., Weede, A., Sullivan-Tibbs, M. A., Rose, L., et al. (2024) · Pain Medicine · doi:10.1093/pm/pnae062 · Cited by 2
Análise econômica das terapias hemodiálise e diálise peritoneal de início urgente
Brabo, A. M., Dias, D. B., da Silva, E. N., & Ponce, D. (2025) · Brazilian Journal of Nephrology · doi:10.1590/2175-8239-jbn-2024-0051pt · Cited by 1
The international trial of nasal oxygen therapy after cardiac surgery (NOTACS) in patients at high risk of postoperative pulmonary complications: Economic evaluation protocol and analysis plan
Shetty, S. S., Duckworth, M., Norman, R., Affandi, J. S., Dawson, S. N., Fox-Rushby, J. A., & On behalf of NOTACS investigators (2025) · PLoS ONE · doi:10.1371/journal.pone.0311861 · Cited by 1
Effectiveness and cost‐effectiveness of high‐intensity versus low‐intensity speech intervention in children with a cleft palate: Protocol for a randomized controlled trial
Allemeersch, F., Lierde, K. M. V., Verhaeghe, N., Bettens, K., Mouton, T., Hens, G., & Alighieri, C. (2025) · International Journal of Language & Communication Disorders · doi:10.1111/1460-6984.70019 · Cited by 1
Improving older people’s experiences and safety at transitions of care: the PACT mixed-methods study including RCT
Murray, J., Baxter, R., O'Hara, J. K., Sheard, L., Hewitt, C. E., Hardicre, N., Vincent, C. A., Oikonomou, E., Richardson, G. A., Shannon, R., et al. (2025) · Programme Grants for Applied Research · doi:10.3310/kmng5684 · Cited by 2
Co-designing a Structured Expert Elicitation with Clinicians to Enhance Health Care Decision Making in Exercise Oncology
Wang, Y., McCarthy, A. L., & Tuffaha, H. (2025) · Medical Decision Making · doi:10.1177/0272989x251332967 · Cited by 1
Cost-effectiveness of Cerebrolysin as an add-on treatment for neurorecovery after traumatic brain injury
Grad, D. A., Strilciuc, Ș., Vlădescu, C., Buzoianu, A. D., Albu, C. V., & Muresanu, D. F. (2025) · Journal of Medicine and Life · doi:10.25122/jml-2025-0087 · Cited by 1
Enhancing early detection and treatment of psychosis in Germany: a protocol for the health economic evaluation of an artificial intelligence-guided complex intervention
Bommhardt, T., Peschl, J., Schultze-Lutter, F., Koutsouleris, N., Meisenzahl, E. M., & Köberlein–Neu, J. (2025) · BMJ Open · doi:10.1136/bmjopen-2025-103151 · Cited by 1
“Furthermore, deterministic sensitivity analyses will be performed with varying discount rates for cost and effects between 0% and 5%.”
Cost-Utility Analysis of Accelerated and Standard Strategies for Renal Replacement Therapy Initiation
Round, J. A., Akpinar, İ., Yan, C., Patel, N., van Katwyk, S., Montgomery, C., Wald, R., Bagshaw, S. M., STARRT-AKI Investigators, Bellomo, R., et al. (2025) · JAMA Network Open · doi:10.1001/jamanetworkopen.2025.35343 · Cited by 1
The Consistency and Transferability of Economic Evaluations of Disease-Modifying Treatments for Multiple Sclerosis: Analysis of Cost-Effectiveness Assessments from Australia, England, Canada and Scotland
Wang, X., Zhao, F.-L., Newby, D., Gao, L., & Li, S. C. (2025) · PharmacoEconomics - Open · doi:10.1007/s41669-025-00606-x · Cited by 1
“Nonetheless, the method is recognised as a valuable tool that is easy to carry out and could provide the essential information needed for decision makers to identify the least costly alternative, especially among interventions with equivalent clinical outcomes [41].”
Active remote monitoring of long-term conditions with mobile devices: a systematic review of cost-effectiveness analyses
Gavan, S. P., Payne, K., Dixon, W. G., van der Veer, S. N., Tam, A. C. T., & Bansback, N. J. (2025) · npj Digital Medicine · doi:10.1038/s41746-025-01898-3 · Cited by 1
“Cost-effectiveness analyses can be embedded alongside a randomised controlled trial (RCT) or may use a decision-analytic modelling framework to simulate cost and health outcomes per patient over a longer time horizon 21,22 .”

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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