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Cited by 146Health and Medical Research ImpactsMeta-analysis and systematic reviewsStatistical Methods in Clinical Trials

The DOI matches its Crossref record; 83 of the 83 references it cites were found in a registry or an index.

Systematic review on costs and resource use of randomized clinical trials shows a lack of transparent and comprehensive data

Speich, Benjamin, von Niederhäusern, Belinda, Schur, Nadine, Hemkens, Lars G., Fürst, Thomas, Bhatnagar, Neera, Alturki, Reem, Agarwal, Arnav, Kasenda, Benjamin, Pauli-Magnus, Christiane, Schwenkglenks, Matthias, Briel, Matthias·2018·Journal of Clinical Epidemiology
DOI 10.1016/j.jclinepi.2017.12.018
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Abstract

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.

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Metadata

Authors
Speich, B., von Niederhäusern, B., Schur, N., Hemkens, L. G., Fürst, T., Bhatnagar, N., Alturki, R., Agarwal, A., Kasenda, B., Pauli-Magnus, C., Schwenkglenks, M., & Briel, M.
Affiliations
  • University of Basel (CH)
  • Swiss Tropical and Public Health Institute (CH)
  • McMaster University (CA)
  • King Fahad Specialist Hospital (SA)
  • University of Toronto (CA)
Corresponding author
Briel, Matthias
ORCID
Venue
Journal of Clinical Epidemiology
Publisher
Elsevier BV
Published
2018-04
Volume
96
Pages
1-11
ISSN
0895-4356 (ISSN-L)
DOI
10.1016/j.jclinepi.2017.12.018
OpenAlex
W2776980134
Cited by
146
References
83
Citations by year
2026: 14 · 2025: 19 · 2024: 25 · 2023: 31 · 2022: 20 · 2021: 15 · 2020: 10 · 2019: 10 · 2018: 2
FWCI
0.98
Type
journal article
Language
en
Open access
closed
Licence
www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations
  • Journal of Clinical Epidemiology (publishedVersion)
  • PubMed (publishedVersion)
  • edoc (University of Basel) (acceptedVersion)
  • edoc (University of Basel) (submittedVersion)
  • Zurich Open Repository and Archive (University of Zurich) (submittedVersion)
Topics
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Health and Medical Research Impacts
  • Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
  • Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Keywords
randomized controlled trials, trial costs, resource utilization (health care), cost transparency, budgeting
MeSH terms
Cost-Benefit Analysis, Humans, Randomized Controlled Trials as Topic, Patient Selection, Disclosure

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