Systematic review on costs and resource use of randomized clinical trials shows a lack of transparent and comprehensive data
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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Randomised trials require considerable funding, typically from drug or device companies (industry funded) or from scientific or private foundations, or governmental or non-governmental organisations (non-industry funded).
“A randomised trial requires considerable funding, typically from drug or device companies (ie, industry funded) or from scientific or private foundations, or governmental or non-governmental organisations (ie, non-industry funded).102”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [102]
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- 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)
- 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
- 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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Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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