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

Speich, Benjamin and von Niederhäusern, Belinda and Schur, Nadine and Hemkens, Lars G. and Fürst, Thomas and Bhatnagar, Neera and Alturki, Reem and Agarwal, Arnav and Kasenda, Benjamin and Pauli-Magnus, Christiane and Schwenkglenks, Matthias and Briel, Matthias and MAking Randomized Trials Affordable Group, . (2018) Systematic review on costs and resource use of randomized clinical trials shows a lack of transparent and comprehensive data. Journal of clinical epidemiology, 96. pp. 1-11.

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Official URL: https://edoc.unibas.ch/62685/

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Abstract

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.; 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.; 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%).; 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.
Faculties and Departments:09 Associated Institutions > Swiss Tropical and Public Health Institute (Swiss TPH)
09 Associated Institutions > Swiss Tropical and Public Health Institute (Swiss TPH) > Department of Epidemiology and Public Health (EPH) > Household Economics and Health Systems Research > Health Systems and Policies (Tediosi)
UniBasel Contributors:Fürst, Thomas
Item Type:Article, refereed
Article Subtype:Research Article
Publisher:Pergamon Press
ISSN:0895-4356
Note:Publication type according to Uni Basel Research Database: Journal article
Identification Number:
Last Modified:09 Apr 2019 15:06
Deposited On:02 Jul 2018 12:01

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