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

  • Author Footnotes
    1 These authors contributed equally to the work reported here and share first authorship.
    Benjamin Speich
    Footnotes
    1 These authors contributed equally to the work reported here and share first authorship.
    Affiliations
    Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University of Basel and University Hospital Basel, Switzerland
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  • Author Footnotes
    1 These authors contributed equally to the work reported here and share first authorship.
    Belinda von Niederhäusern
    Footnotes
    1 These authors contributed equally to the work reported here and share first authorship.
    Affiliations
    Clinical Trial Unit, Department of Clinical Research, University of Basel and University Hospital Basel, Basel, Switzerland
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  • Nadine Schur
    Affiliations
    Institute of Pharmaceutical Medicine, University of Basel, Basel, Switzerland
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  • Lars G. Hemkens
    Affiliations
    Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University of Basel and University Hospital Basel, Switzerland
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  • Thomas Fürst
    Affiliations
    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
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  • Neera Bhatnagar
    Affiliations
    Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada
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  • Reem Alturki
    Affiliations
    Multi Organ Transplant Center, King Fahad Specialist Hospital Dammam, P.O. Box 15215, Dammam 31444, Saudi Arabia
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  • Arnav Agarwal
    Affiliations
    Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada

    School of Medicine, University of Toronto, Toronto, Ontario, Canada
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  • Benjamin Kasenda
    Affiliations
    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
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  • Christiane Pauli-Magnus
    Affiliations
    Clinical Trial Unit, Department of Clinical Research, University of Basel and University Hospital Basel, Basel, Switzerland
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  • Author Footnotes
    2 These authors contributed equally to the work reported here and share last authorship.
    Matthias Schwenkglenks
    Footnotes
    2 These authors contributed equally to the work reported here and share last authorship.
    Affiliations
    Institute of Pharmaceutical Medicine, University of Basel, Basel, Switzerland

    Epidemiology, Biostatistics and Prevention Institute, University of Zürich, Zürich, Switzerland
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  • Author Footnotes
    2 These authors contributed equally to the work reported here and share last authorship.
    Matthias Briel
    Correspondence
    Corresponding author. Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University of Basel and University Hospital Basel, Spitalstrasse 12, 4031 Basel, Switzerland. Tel.: +41 61 3285092; fax: +41 61 2653109.
    Footnotes
    2 These authors contributed equally to the work reported here and share last authorship.
    Affiliations
    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
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  • for theMAking Randomized Trials Affordable (MARTA) Group
  • Author Footnotes
    1 These authors contributed equally to the work reported here and share first authorship.
    2 These authors contributed equally to the work reported here and share last authorship.
Published:December 26, 2017DOI:https://doi.org/10.1016/j.jclinepi.2017.12.018

      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.

      Keywords

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