Abstract
BackgroundThe preparation of a randomized controlled trial (RCT) requires substantial resources and the administrative processes can be burdensome. To facilitate the conduct of RCTs it is important to better understand cost drivers. In January 2014 the enactment of the new Swiss Legislation on Human Research (LHR) considerably changed the regulatory framework in Switzerland. We assess if the new LHR was associated with change in (i) resource use and costs to prepare an RCT, and (ii) approval times with research ethics committees (RECs) and the regulatory authority Swissmedic.MethodsWe surveyed investigators of RCTs which were approved by RECs in 2012 or in 2016 and asked for RCT preparation costs using a pre-specified item list. Additionally, we collected approval times from RECs and Swissmedic.ResultsThe response rates of the investigator survey were 8.3% (19/228) for 2012 and 16.5% (47/285) in 2016. The median preparation cost of an RCT was USD 72,400 (interquartile range [IQR]: USD 59,500–87,700; n = 18) in 2012 and USD 72,600 (IQR: USD 42,800–169,600; n = 35) in 2016. For single centre RCTs a median REC approval time of 82 (IQR: 49–107; n = 38) days in 2012 and 92 (IQR: 65–131; n = 63) days in 2016 was observed. The median Swissmedic approval time for any clinical trial was 27 (IQR: 19–51; n = 213) days in 2012 and 49 (IQR: 36–67; n = 179) days in 2016. The total duration for achieving RCT approval from both authorities (REC and Swissmedic) in the parallel submission procedure applied in 2016 could not be assessed.ConclusionBased on limited data the costs to plan and prepare RCTs in Switzerland were approximately USD 72,000 in 2012 and 2016. For effective and valid research on costs and approval times of RCTs a greater willingness to share cost information among investigators and more collaboration between stakeholders with data linkage is necessary.
Highlights
Randomized controlled trials (RCTs) provide the most reliable evidence on therapeutic and preventive interventions for decision-making in clinical practice and health policy [1]
This is problematic for two reasons: First, pharmaceutical companies argue that high prices for new interventions are justified by the high development costs which are mostly driven by costs for RCTs [5,6,7]
This study underlined that collecting cost data for RCTs in Switzerland is difficult since these data are usually not documented in a systematic way
Summary
Randomized controlled trials (RCTs) provide the most reliable evidence on therapeutic and preventive interventions for decision-making in clinical practice and health policy [1]. The available evidence on RCT costs is limited, it is assumed that the administrative burden as well as the costs for RCTs have increased substantially over the last decades [1,2,3,4] This is problematic for two reasons: First, pharmaceutical companies argue that high prices for new interventions are justified by the high development costs which are mostly driven by costs for RCTs [5,6,7]. When academic clinical trials are becoming unfeasible, many important clinical questions without prospect for financial profit will remain unanswered To improve this situation, it is important to know what causes the burden to conduct clinical research (i.e. what are cost drivers that hamper the planning and conduct of RCTs). We assess if the new LHR was associated with change in (i) resource use and costs to prepare an RCT, and (ii) approval times with research ethics committees (RECs) and the regulatory authority Swissmedic
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
