在新的瑞士人类研究法规实施前后，规划和准备随机临床试验的资源利用、成本和审批时间。
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.
机构信息
Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University of Basel and University Hospital Basel, Basel, Switzerland.
Institute of Pharmaceutical Medicine, University of Basel, Basel, Switzerland.
出版信息
PLoS One. 2019 Jan 11;14(1):e0210669. doi: 10.1371/journal.pone.0210669. eCollection 2019.
BACKGROUND
The 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.
METHODS
We 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.
RESULTS
The 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.
CONCLUSION
Based 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.
背景
准备一项随机对照试验（RCT）需要大量资源，并且行政流程可能很繁琐。为了便于进行 RCT，了解成本驱动因素非常重要。 2014 年 1 月，新的《瑞士人类研究法》（LHR）的颁布极大地改变了瑞士的监管框架。我们评估新的 LHR 是否与以下方面的变化有关：（i）准备 RCT 的资源使用和成本，以及（ii）伦理委员会（RECs）和监管机构 Swissmedic 的批准时间。
方法
我们调查了 2012 年或 2016 年由 REC 批准的 RCT 研究人员，并使用预先确定的项目清单询问了 RCT 准备成本。此外，我们还从 REC 和 Swissmedic 收集了批准时间。
结果
2012 年和 2016 年的调查员调查响应率分别为 8.3%（228 人中有 19 人）和 16.5%（285 人中有 47 人）。2012 年 RCT 的平均准备成本为 72,400 美元（四分位距 [IQR]：59,500-87,700 美元；n=18），2016 年为 72,600 美元（IQR：42,800-169,600 美元；n=35）。对于单中心 RCT，2012 年 REC 批准时间的中位数为 82（IQR：49-107；n=38）天，2016 年为 92（IQR：65-131；n=63）天。2012 年，任何临床试验的 Swissmedic 批准时间中位数为 27（IQR：19-51；n=213）天，2016 年为 49（IQR：36-67；n=179）天。在 2016 年采用的平行提交程序中，无法评估从两个主管部门（REC 和 Swissmedic）获得 RCT 批准的总时间。
结论
根据有限的数据，2012 年和 2016 年在瑞士计划和准备 RCT 的成本约为 72,000 美元。为了对 RCT 的成本和批准时间进行有效和有效的研究，研究人员之间需要更愿意共享成本信息，利益相关者之间需要更多的协作和数据链接。
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