由瑞士国家科学基金会支持的随机临床试验的资助特征：一项回顾性队列研究。

Funding characteristics of randomised clinical trials supported by the Swiss National Science Foundation: a retrospective cohort study.

作者信息

Amstutz Alain, Schandelmaier Stefan, Frei Roy, Surina Jakub, Agarwal Arnav, Alturki Reem, von Niederhäusern Belinda, von Elm Erik, Briel Matthias

机构信息

Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University of Basel and University Hospital Basel, Switzerland.

Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University of Basel and University Hospital Basel, Switzerland / Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Onta.

出版信息

Swiss Med Wkly. 2018 Jan 26;148:w14587. doi: 10.4414/smw.2018.14587. eCollection 2018.

DOI:10.4414/smw.2018.14587

PMID:29376558

Abstract

AIMS OF THE STUDY

Failure to publish publicly funded research represents a waste of scarce research resources across medical disciplines and countries. In Switzerland, about 40% of randomised clinical trials (RCTs) supported by the Swiss National Science Foundation (SNSF) were not published. We aimed to describe funding characteristics of published and unpublished RCTs supported by the SNSF, to quantify the amount of money spent for unpublished studies, and to compare our results to a similar study performed in the UK.

METHODS

We established a retrospective cohort of RCTs funded by the SNSF up to 2015. For each RCT proposal, two investigators independently identified corresponding publications in electronic databases and trial registries. Teams of two investigators independently extracted details from the original SNSF proposal and, if available, from trial registries or publications. In addition, we surveyed principal investigators about trial costs and additional sources of funding.

RESULTS

We included 101 RCTs supported by the SNSF between 1986 and 2015. Most were single-centre RCTs with a median of 138 participants (interquartile range [IQR] 76-400). Overall, 67 (67%) principal investigators responded to our main survey questions. Median total costs per RCT were CHF 428 000 (IQR 282 000-900 000) of which the SNSF provided a median CHF 222 000 (67% of total costs, IQR 40-80%). Most investigators (70%) mentioned additional funding, mainly from their own institution or private foundations. A total of CHF 6.7 million was granted to RCTs that remained unpublished. Funding characteristics were similar to publicly funded trials in the UK.

CONCLUSIONS

A third of the total SNSF grant sum spent on healthcare RCTs between 1986 and 2015 did not result in peer-reviewed scientific publications. New SNSF grant schemes might improve publication outcomes but their effectiveness needs to be evaluated.

摘要

研究目的

未能发表由公共资金资助的研究成果，意味着在各个医学学科和国家中，稀缺的研究资源被浪费了。在瑞士，由瑞士国家科学基金会（SNSF）资助的随机临床试验（RCT）中，约有40%未发表。我们旨在描述由SNSF资助的已发表和未发表的RCT的资助特征，量化未发表研究的资金支出，并将我们的结果与在英国进行的一项类似研究进行比较。

方法

我们建立了一个回顾性队列，纳入截至2015年由SNSF资助的RCT。对于每个RCT提案，两名研究人员独立在电子数据库和试验注册库中识别相应的出版物。由两名研究人员组成的团队独立从原始的SNSF提案中提取细节，并在可行的情况下，从试验注册库或出版物中提取细节。此外，我们向主要研究者调查了试验成本和其他资金来源。

结果

我们纳入了1986年至2015年间由SNSF资助的101项RCT。大多数是单中心RCT，参与者中位数为138人（四分位间距[IQR]76 - 400）。总体而言，67名（67%）主要研究者回复了我们的主要调查问题。每项RCT的总成本中位数为42.8万瑞士法郎（IQR 28.2万 - 90万），其中SNSF提供的中位数为22.2万瑞士法郎（占总成本的67%，IQR 40% - 80%）。大多数研究者（70%）提到了额外资金，主要来自他们自己的机构或私人基金会。总计670万瑞士法郎被授予了仍未发表的RCT。资助特征与英国的公共资助试验相似。