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An Economic Model for Estimating Trial Costs with an Application to Placebo Surgery Trials

Author

Listed:
  • Chris Schilling

    (The University of Melbourne)

  • Michelle Tew

    (Centre for Health Policy, University of Melbourne)

  • Samantha Bunzli

    (The University of Melbourne)

  • Cade Shadbolt

    (The University of Melbourne)

  • L. Stefan Lohmander

    (University of Lund)

  • Zsolt J. Balogh

    (The University of Newcastle)

  • Francesco Paolucci

    (University of Newcastle
    University of Bologna)

  • Peter F. Choong

    (The University of Melbourne
    St. Vincent’s Hospital)

  • Michelle M. Dowsey

    (The University of Melbourne
    St. Vincent’s Hospital)

  • Philip Clarke

    (Centre for Health Policy, University of Melbourne
    University of Oxford)

Abstract

Background and Objective Waste in clinical trials remains rife. We developed an economic model to predict the cost of trials based on input costs, duration, power, number of sites, recruitment eligibility and consenting rates. Methods We parameterised the model for three proxy placebo-controlled surgical trials using data from a systematic review, a bespoke cost survey, and from the literature. We used the model to compare target and actual trial performance for (i) a trial that was completed on time but with more sites, (ii) a trial that completed after a time extension, and (iii) an incomplete trial. Results Successful trials more accurately anticipated the true recruitment rate that they achieved and those that overestimated this were most likely to fail. The costs of overestimating recruitment rates were dramatic: all proxy trials had significantly higher costs than planned, with additional funding of at least AUD$600,000 (50% above budget) required for trials that completed after adding more sites or more time, and over AUD$2 million (260% above budget) for incomplete trials. Conclusions This model shows the trade-offs between time and cost, or both, when recruitment is lower than anticipated. Greater consideration is needed to improve trial planning, reviewing, and funding of these trials to avoid costly overruns and incomplete trials.

Suggested Citation

  • Chris Schilling & Michelle Tew & Samantha Bunzli & Cade Shadbolt & L. Stefan Lohmander & Zsolt J. Balogh & Francesco Paolucci & Peter F. Choong & Michelle M. Dowsey & Philip Clarke, 2023. "An Economic Model for Estimating Trial Costs with an Application to Placebo Surgery Trials," Applied Health Economics and Health Policy, Springer, vol. 21(2), pages 263-273, March.
  • Handle: RePEc:spr:aphecp:v:21:y:2023:i:2:d:10.1007_s40258-022-00775-4
    DOI: 10.1007/s40258-022-00775-4
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    References listed on IDEAS

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    1. Connelly, Luke B., 2003. "Balancing the Number and Size of Sites: An Economic Approach to the Optimal Design of Cluster Samples," MPRA Paper 14676, University Library of Munich, Germany.
    2. Drummond, Michael F. & Sculpher, Mark J. & Claxton, Karl & Stoddart, Greg L. & Torrance, George W., 2015. "Methods for the Economic Evaluation of Health Care Programmes," OUP Catalogue, Oxford University Press, edition 4, number 9780199665884, Decembrie.
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