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Effect of the Swiss human research legislation on the costs associated with randomized clinical trials in Switzerland

Research Project
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01.08.2015
 - 30.04.2018

In any medical and health related field there is often uncertainty from which of two or more available treatment options a patient would profit most. Allocating groups of patients randomly to different treatment options in the context of so-called randomised controlled trials (RCTs) provides the most reliable comparisons and evidence for decision making in clinical practice. However, the conduct of RCTs is costly, administratively burdensome and highly regulated to protect study participants. The conduct of an RCT does not only consist of patient enrolment, treatment and follow-up, but also of a comprehensive preparation phase, during which multiple tasks have to be accomplished. For example, a study protocol and a number of other documents need to be created, approval from research ethics committees (RECs) and in some cases from the Swiss Agency for Therapeutic Products ( Swissmedic ) has to be obtained. To create favourable research conditions in Switzerland, the new law on research with human beings (Human Research Act) and its ordinances, jointly abbreviated in this report as Swiss Legislation on Human Research (LHR), was enacted in January 2014. The main aim of this study was to assess if the new LHR had an impact on the administrative burden and costs to plan and prepare an RCT. To find out about required working efforts and costs to plan and prepare an RCT, we contacted investigators from RCTs which were approved by Swiss RECs in 2012 and 2016 (before and after the implementation of the LHR). Investigators received a comprehensive excel sheet in which all possible preparation steps for an RCT were listed. They were asked to retrospectively estimate the working efforts for all involved staff members and to give information about fixed costs. Based on this information, we aimed to calculate the working efforts and the costs to plan and prepare an RCT. Furthermore, we assessed approval times (i.e. times from submission of study documents until final approval) by RECs and Swissmedic. We received complete resource use and cost data for the preparation phase of 18 RCTs which were approved in 2012 and of 35 RCTs which were approved in 2016. The median working time to plan and prepare an RCT was 113 days (25 th to 75 th percentile range [IQR]: 51-190 days) in 2012 and 133 days (IQR: 79-239 days) in 2016. The median costs to plan and prepare these RCTs were estimated to be CHF 81'100 (IQR: CHF 69'500-123'100) in 2012 and CHF 73'800 (IQR: CHF 43'500-176'700) in 2016. Given the small number of RCTs for which we received data and a strong possibility of selection effects, it was not possible to draw firm conclusions on a cost impact of the LHR. Approval times from RECs were available for a total of 183 RCTs approved in 2012 and 217 RCTs approved in 2016. The median time from application to approval was 72 days (IQR: 41-72 days) in 2012 and 109 days (IQR: 79-154 days) in 2016. Further data provided by Swissmedic indicated that Swissmedic approval times for clinical trials (not only RCTs) were also longer in 2016 (median: 27.0 days; IQR: 19.0-50.5 days) than in 2012 (median: 49.0 days; IQR: 36.0-67.0 days). Gathering actual resource use and cost data for RCTs was difficult, because such information was not systematically documented and it required active collaboration of RCT investigators to comprehensively capture spent resources. Due to the sparseness of the available data, we could not draw firm conclusions regarding changes in the working efforts and costs for the preparation phases of RCTs. Approval times by RECs and Swissmedic were higher in 2016 compared to 2012. However, it is difficult to differentiate whether these differences were due to the LHR or due to other reasons.

Funding

Effect of the Swiss human research legislation on the costs associated with randomized clinical trials in Switzerland

Ressortforschung des Bundes (GrantsTool), 08.2015-06.2017 (23)
PI : Schwenkglenks, Matthias.
CI : Briel, Matthias,Szucs, Thomas.

Publications

Speich, Benjamin et al. (2018) ‘Retrospective assessment of resource use and costs in two investigator-initiated randomized trials exemplified a comprehensive cost item list’, Journal of clinical epidemiology, 96, pp. 73–83. Available at: https://doi.org/10.1016/j.jclinepi.2017.12.022.

URLs
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Members (3)

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Matthias Schwenkglenks

Principal Investigator
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Matthias Briel

Co-Investigator
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Thomas Szucs

Co-Investigator