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

Chris Schilling (), Michelle Tew (), Samantha Bunzli (), Cade Shadbolt (), L. Stefan Lohmander (), Zsolt J. Balogh (), Francesco Paolucci (), Peter F. Choong (), Michelle M. Dowsey () and Philip Clarke ()
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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
Peter F. Choong: The University of Melbourne
Michelle M. Dowsey: The University of Melbourne
Philip Clarke: Centre for Health Policy, University of Melbourne

Applied Health Economics and Health Policy, 2023, vol. 21, issue 2, No 8, 263-273

Abstract: 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.

Date: 2023
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DOI: 10.1007/s40258-022-00775-4

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