MAking Randomized Trials Affordable 

Randomized Controlled Trials (RCTs) are considered the gold standard to evaluate the safety and efficacy of treatments and interventions in clinical research. Conducting high-quality RCTs is challenging, time consuming and resource intensive. Consequently, tens of billions of dollars of public and private money are invested into this sector every year. Furthermore, RCT costs are rising in response to escalating trial complexity, stricter regulation, and increasing administrative burden. 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 project is to “MAking Randomized Trials Affordable” (MARTA). In a first step we showed that the usefulness of the available evidence on resource use and costs for RCTs is very limited. We therefore made first cost estimates for two RCTs publicly available together with a comprehensive cost item list to also encourage other researchers to share cost data. As a larger sample of empiric cost data on RCTs is needed, we are currently conducting a study in which we aim 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 to identify cost patterns and potential cost drivers.

Further goals of the MARTA project are to improve the budgeting and cost monitoring for investigator initiated RCTs, so that more trials can be completed as planned.

Study Protocol

Griessbach, A., Briel, M., & Speich, B. (2021, June 4). Empirical investigation of resource use and costs of investigator-initiated randomized controlled trials in four countries.

Results publications:

Systematic review on costs and resource use of randomized clinical trials shows a lack of transparent and comprehensive data (J Clin Epidemiol. 2018)

Retrospective assessment of resource use and costs in two investigator-initiated randomized trials exemplified a comprehensive cost item list (J Clin Epidemiol. 2018)

Funding characteristics of randomised clinical trials supported by the Swiss National Science Foundation: a retrospective cohort study (Swiss Med Wkly 2018)

Resource use, costs, and approval times for planning and preparing a randomized clinical trial before and after the implementation of the new Swiss human research legislation (PLoS One 2019)

Current use and costs of electronic health records for clinical trial research: a descriptive study (CMAJ Open 2019)

A scoping review shows that several nonvalidated budget planning tools for randomized trials are available (J Clin Epidemiol. 2020)

A meta-research study revealed several challenges in obtaining placebos for investigator-initiated drug trials (J Clin Epidemiol. 2021)

Practices and Attitudes of Swiss Stakeholders Regarding Investigator-Initiated Clinical Trial Funding Acquisition and Cost Management (JAMA Netw Open 2021)

Contact person

Benjamin Speich