Design and rationale for an empirical investigation of the resource use and costs of investigator-initiated randomized trials in Switzerland, the United Kingdom, 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 United Kingdom. Investigators enter their empirical costs data into an online case report form, which is followed by a short interview and a detailed cost report. We plan to investigate cost patterns and cost drivers, examine planned versus actual RCT costs as well as explore the heterogeneity 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. Registration: Open Science Framework (OSF) https://doi.org/10.17605/OSF.IO/QY2GU