Summary
The aim of this research program is to empirically investigate resource use and costs of randomized clinical trials in order to identify cost patterns and potential lever points for a more cost-efficient conduct of clinical trials. In addition, we are using mixed methods to explore heterogeneity of costs across medical fields and countries, and current practices, attitudes, and needs with respect to budget planning and funding acquisition for clinical trials in Switzerland. We work towards a stakeholder consensus regarding the definition of relevant budget items, and the development of suitable tools.

Basel research team
Benjamin Speich, Lars Hemkens, Gilles Dutilh, Christiane Pauli-Magnus, Matthias Briel

Publications

• Speich B, Gloy V, Schur N, Ewald H, Mc Cord KA, Hemkens LG, Briel M. A scoping review showed that several non-validated budget planning tools for randomised trials are available. J Clin Epidemiol 2019 (Epub ahead of print)
• Speich B, Schur N, Gryaznov D, von Niederhäusern B, Hemkens LG, Schandelmaier S, Amstutz A, Kasenda B, Pauli-Magnus C, Ojeda Ruiz E, Tomonaga Y, McCord K, Nordmann A, von Elm E, Briel M, Schwenkglenks M. 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;14(1):e0210669
• Mc Cord KA, Ewald H, Ladanie A, Briel M, Speich B, Bucher HC, Hemkens LG. Current use and costs of electronic health records for clinical trial research: A descriptive study. CMAJ Open 2019;7(1):E23-E32
• Amstutz A, Schandelmaier S, Frei R, Surina J, Agarwal A, Olu KK, Alturki R, von Niederhäusern B, von Elm E, Briel M. Funding characteristics of Randomized Clinical Trials supported by the Swiss National Science Foundation: a Retrospective Cohort Study. Swiss Med Wkly 2018;148:w14587
• Speich B, von Niederhäusern B, Blum CA, Keiser J, Schur N, Bathelt C, Fürst T, Kasenda B, Christ-Crain M, Hemkens LG, Pauli-Magnus C, Schwenkglenks M, Briel M. Retrospective assessment of resource use and costs in two investigator-initiated randomised trials exemplifies a comprehensive cost item list. J Clin Epidemiol 2018;96:73-83
• Speich B, von Niederhäusern B,  Schur N, Hemkens LG, Fürst T, Bhatnagar N, Alturki R, Agarwal A, Kasenda B, Pauli-Magnus C, Schwenkglenks M, Briel M. Systematic review on costs and resource use of randomised clinical trials shows a lack of transparent and comprehensive data.J Clin Epidemiol 2018;96:1-11