Investigator-Initiated RCT Cost Analysis: A Multi-Country Observational Study
核心洞察
A new observational study aims to collect detailed cost data from 100 investigator-initiated randomized controlled trials (RCTs (搜索)) across Switzerland, Germany, and the UK.
The study will investigate cost patterns, including the largest cost items, for the entire RCT process, from planning to finalization, both in absolute terms and as a percentage of total costs.
Researchers will explore RCT costs across different medical fields, intervention types, and countries, while also examining planned versus actual costs to identify factors contributing to excess expenses.
An observational study is underway to generate a comprehensive database of resource use and cost data from 100 investigator-initiated randomized controlled trials (RCTs (搜索)) across Switzerland, Germany, and the UK. The study aims to provide insights into the economic aspects of academic clinical research, which could inform strategies for optimizing resource allocation and trial design.
Study Design and Objectives
The study, registered on Open Science Framework, will retrospectively collect detailed empirical cost and resource use data. The primary objectives are to investigate cost patterns on both absolute and relative scales, explore RCT costs across various strata (medical fields, intervention types, multi-center/single center status, and countries), examine planned versus actual RCT costs, and explore hidden costs associated with conducting an RCT.
The researchers hypothesize that participant recruitment and follow-up typically constitute the largest proportion of total RCT costs, data monitoring accounts for less than 15% of total RCT costs, delays in recruitment explain most of the excess costs, and cost structures are similar across medical fields and countries.
Methodology
Eligible RCTs (搜索) must be completed or near completion, investigator-initiated, and not industry-sponsored. Data will be collected using a previously developed cost item list that follows principles of activity-based costing. The data collection involves gathering both fixed costs (e.g., ethical approval fees, insurance) and variable costs (e.g., time spent on protocol writing, patient screening) associated with the trial.
Trial teams will enter their cost and resource data directly into an online data collection form, followed by an interview to clarify any unclear or missing data. A cost report will be generated for each trial and reviewed by the trial team. Relevant RCT baseline characteristics will be extracted from protocols and publications, including medical field, type of intervention, sample size, trial duration, and funding sources.
Sample Size and Statistical Analysis
Originally, the study aimed to include 180 RCTs (搜索), but due to challenges in finding principal investigators willing to share cost data, the target was reduced to 100 RCTs (Switzerland n = 60; Germany n = 20; UK n = 20). This sample size is deemed feasible and sufficient for unstratified estimates and multivariable regression analyses.
Simulations were conducted to determine the required sample size to achieve a 90% probability of a sufficiently narrow 95% confidence interval around the estimated mean cost proportions for individual cost items. The study anticipates that the collected data will provide valuable insights into the cost drivers of investigator-initiated RCTs (搜索), which can inform strategies for improving trial efficiency and resource allocation.