Background: Randomised clinical trials (RCTs) provide the most reliable evidence on therapeutic and preventive interventions for decision-making in clinical practice and health policy, but they are resource-intense and costly. In a recently conducted systematic review we found that published evidence on RCT costs is sparse and the validity and usefulness of the available data is limited.
Objectives: To collect detailed resource use and cost data from RCTs using transparent and standardised methods to create a publicly accessible repository for evidence-based budget planning and cost monitoring in RCTs.
Methods: We compiled a comprehensive list of resource use and cost items for RCTs based on a systematic literature review and internet search, which was further adapted and pilot tested by 12 clinical trial experts. This item list was then sent to 146 investigators of RCTs that were approved by research ethics committees in Switzerland in 2012. Within the item list investigators were asked about working efforts for all involved staff members and fixed costs for specific items during 1) the planning and preparation phase; 2) the patient enrolment, treatment and follow-up phase; and 3) after the last patient out phase. We calculated costs per RCT, cost per patient, costs per site and costs per study phase.
Results: We have currently collected resource use and cost data from 10 investigator-initiated RCTs. The median sample size was 175 patients (interquartile range (IQR) 32 to 561) and the median costs were USD 500,912 (IQR USD 159,385 to 987,424). The median costs per patient were USD 2879 (IQR USD 1141 to 13,608) and the median costs per site were USD 144,426 (IQR USD 31,714 to 469,807). The patient enrolment, treatment and follow-up phase accounted for the largest costs among all studies (median of 54% of total costs; IQR 40.4% to 72.0%), followed by the planning and preparation phase (median 26.1%; IQR 18.9% to 41.4%) and the after last patient out phase (median 16.3%; IQR 5.3% to 24.1%). At the time of the Colloquium we will present updated and more detailed results including an analysis of cost drivers.
Conclusion: This case series transparently provides data on the costs of investigator-initiated RCTs using standardised methods. An accessible repository of RCT costs will enable analyses to make RCTs more cost-efficient.
Patient involvement: Not applicable.