Systematic review on costs and resource use of randomized clinical trials shows a lack of transparent and comprehensive data.
- Speich B Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University of Basel and University Hospital Basel, Switzerland.
- von Niederhäusern B Clinical Trial Unit, Department of Clinical Research, University of Basel and University Hospital Basel, Basel, Switzerland.
- Schur N Institute of Pharmaceutical Medicine, University of Basel, Basel, Switzerland.
- Hemkens LG Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University of Basel and University Hospital Basel, Switzerland.
- Fürst T Department of Epidemiology and Public Health, Swiss Tropical and Public Health Institute, University of Basel, Basel, Switzerland; School of Public Health, Imperial College London, London, United Kingdom.
- Bhatnagar N Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.
- Alturki R Multi Organ Transplant Center, King Fahad Specialist Hospital Dammam, P.O. Box 15215, Dammam 31444, Saudi Arabia.
- Agarwal A Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada; School of Medicine, University of Toronto, Toronto, Ontario, Canada.
- Kasenda B Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University of Basel and University Hospital Basel, Switzerland; Department of Medical Oncology, University of Basel and University Hospital Basel, Switzerland.
- Pauli-Magnus C Clinical Trial Unit, Department of Clinical Research, University of Basel and University Hospital Basel, Basel, Switzerland.
- Schwenkglenks M Institute of Pharmaceutical Medicine, University of Basel, Basel, Switzerland; Epidemiology, Biostatistics and Prevention Institute, University of Zürich, Zürich, Switzerland.
- Briel M Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University of Basel and University Hospital Basel, Switzerland; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada. Electronic address: matthias.briel@usb.ch.
- 2017-12-31
Published in:
- Journal of clinical epidemiology. - 2018
Clinical trial cost
Cost drivers
Randomized clinical trials
Resource use
Systematic review
Trial feasibility
Cost-Benefit Analysis
Disclosure
Humans
Patient Selection
Randomized Controlled Trials as Topic
English
OBJECTIVES
Randomized clinical trials (RCTs) are costly. We aimed to provide a systematic overview of the available evidence on resource use and costs for RCTs to support budget planning.
STUDY DESIGN AND SETTING
We systematically searched MEDLINE, EMBASE, and HealthSTAR from inception until November 30, 2016 without language restrictions. We included any publication reporting empirical data on resource use and costs of RCTs and categorized them depending on whether they reported (i) resource and costs of all aspects at all study stages of an RCT (including conception, planning, preparation, conduct, and all tasks after the last patient has completed the RCT); (ii) on several aspects, (iii) on a single aspect (e.g., recruitment); or (iv) on overall costs for RCTs. Median costs of different recruitment strategies were calculated. Other results (e.g., overall costs) were listed descriptively. All cost data were converted into USD 2017.
RESULTS
A total of 56 articles that reported on cost or resource use of RCTs were included. None of the articles provided empirical resource use and cost data for all aspects of an entire RCT. Eight articles presented resource use and cost data on several aspects (e.g., aggregated cost data of different drug development phases, site-specific costs, selected cost components). Thirty-five articles assessed costs of one specific aspect of an RCT (i.e., 30 on recruitment; five others). The median costs per recruited patient were USD 409 (range: USD 41-6,990). Overall costs of an RCT, as provided in 16 articles, ranged from USD 43-103,254 per patient, and USD 0.2-611.5 Mio per RCT but the methodology of gathering these overall estimates remained unclear in 12 out of 16 articles (75%).
CONCLUSION
The usefulness of the available empirical evidence on resource use and costs of RCTs is limited. Transparent and comprehensive resource use and cost data are urgently needed to support budget planning for RCTs and help improve sustainability.
Randomized clinical trials (RCTs) are costly. We aimed to provide a systematic overview of the available evidence on resource use and costs for RCTs to support budget planning.
STUDY DESIGN AND SETTING
We systematically searched MEDLINE, EMBASE, and HealthSTAR from inception until November 30, 2016 without language restrictions. We included any publication reporting empirical data on resource use and costs of RCTs and categorized them depending on whether they reported (i) resource and costs of all aspects at all study stages of an RCT (including conception, planning, preparation, conduct, and all tasks after the last patient has completed the RCT); (ii) on several aspects, (iii) on a single aspect (e.g., recruitment); or (iv) on overall costs for RCTs. Median costs of different recruitment strategies were calculated. Other results (e.g., overall costs) were listed descriptively. All cost data were converted into USD 2017.
RESULTS
A total of 56 articles that reported on cost or resource use of RCTs were included. None of the articles provided empirical resource use and cost data for all aspects of an entire RCT. Eight articles presented resource use and cost data on several aspects (e.g., aggregated cost data of different drug development phases, site-specific costs, selected cost components). Thirty-five articles assessed costs of one specific aspect of an RCT (i.e., 30 on recruitment; five others). The median costs per recruited patient were USD 409 (range: USD 41-6,990). Overall costs of an RCT, as provided in 16 articles, ranged from USD 43-103,254 per patient, and USD 0.2-611.5 Mio per RCT but the methodology of gathering these overall estimates remained unclear in 12 out of 16 articles (75%).
CONCLUSION
The usefulness of the available empirical evidence on resource use and costs of RCTs is limited. Transparent and comprehensive resource use and cost data are urgently needed to support budget planning for RCTs and help improve sustainability.
- Language
-
- English
- Open access status
- green
- Identifiers
-
- DOI 10.1016/j.jclinepi.2017.12.018
- PMID 29288136
- Persistent URL
- https://sonar.rero.ch/global/documents/11711
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