Design and rationale for an empirical investigation of the resource use and costs of investigator-initiated randomized trials in Switzerland, the UK, and Germany

Abstract

Background: Conducting high-quality randomized clinical trials (RCTs) is challenging, time consuming, and resource intense. Academic investigators usually depend on scarce financial resources; however, current literature lacks systematically collected empirical data on the detailed resource use and costs of investigator-initiated RCTs.

Methods: The aim of this study is to generate a database of detailed empirical resource use and cost data from 100 investigator-initiated RCTs in Switzerland, Germany, and the UK. Investigators enter their empirical costs data into an online data collection form, which is followed by a short interview and a detailed cost report. We plan to investigate cost patterns and cost drivers and examine planned versus actual RCT costs as well as explore different strata of costs across the planning, conduct, and finalization phases, in drug and non-drug trials, and across medical fields and countries.

Discussion: This study will add detailed empirical data to the limited research on investigator-initiated RCT costs currently available. A study limitation will be that cost data will be retrospective and self-reported, which might be inaccurate depending on how costs were recorded.

Trial registration: Open Science Framework (OSF) https://doi.org/10.17605/OSF.IO/QY2GU . Registered on June 4, 2021.

Keywords: Conduct; Costs; Costs of clinical trials; Finalization; Planning; RCTs; Resource use.

Fig. 1

The required sample size (on the y-axis) required to achieve, with a probability of 90%, an estimate of the mean item cost proportion that has a confidence interval (CI95) smaller than ± 3%, as a function of the true mean item cost proportion (on the x-axis). The different lines represent different assumptions about the distribution of cost proportions across studies