Randomized Controlled Trials (RCTs) are considered the gold standard to evaluate the safety and efficacy of treatments and interventions in clinical research (1). Conducting high-quality RCTs is challenging, time consuming and resource intensive (2–4). Consequently, tens of billions of dollars of public and private money are invested into this sector every year (5). Furthermore, RCT costs are rising in response to escalating trial complexity, stricter regulation, and increasing administrative burden (2,6–9). Academic investigators usually depend on scarce financial resources, thus efforts to improve the cost-effectiveness of RCTs are urgently needed. Current literature, however, lacks systematically collected empirical data on detailed resource use and costs of investigator-initiated RCTs.
The aim of this study is to generate a database of detailed empirical resource use and cost data from 180 investigator-initiated RCTs in Switzerland, Germany, Canada, and the United Kingdom (UK).