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瑞士利益攸关方在研究者发起的临床试验资助获取和成本管理方面的实践和态度。

Practices and Attitudes of Swiss Stakeholders Regarding Investigator-Initiated Clinical Trial Funding Acquisition and Cost Management.

机构信息

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

Institute of History and Ethics in Medicine, Technical University of Munich, Munich, Germany.

出版信息

JAMA Netw Open. 2021 Jun 1;4(6):e2111847. doi: 10.1001/jamanetworkopen.2021.11847.

Abstract

IMPORTANCE

Randomized clinical trials (RCTs) are an essential method of evaluating health care interventions and a cornerstone for evidence-based health care. However, RCTs have become increasingly complex and costly, which is particularly challenging for independent investigator-initiated clinical trials (IICTs). IICTs have an essential role in clinical research, and it is important that efforts are made to ensure IICTs are adequately funded and are conducted cost-effectively.

OBJECTIVE

To examine the practices and attitudes of Swiss stakeholders regarding IICT funding acquisition and cost management.

DESIGN, SETTING, AND PARTICIPANTS: For this qualitative study, interviews were conducted in Switzerland between February and August 2020. The purposive sample comprised 48 stakeholders from 4 different groups: primary investigators (n = 27), funders and sponsors (n = 9), clinical trial support organizations (n = 6), and ethics committee members (n = 6).

MAIN OUTCOMES AND MEASURES

Practices and attitudes of stakeholders regarding IICT funding acquisition and cost management were assessed using individual semistructured qualitative interviews. Interviews were analyzed using conventional content analysis.

RESULTS

After interviews with 48 IICT stakeholders (75% male presenting), these participants identified a systemic problem of IICTs being underfunded, which can lead to compromises being made regarding the quality and conduct of IICTs. Participants identified 2 overarching and interconnected groups of reasons why IICTs in Switzerland are regularly underfunded. First, it was reported that IICT budget estimations are often inaccurate because of poor planning and preparation, unforeseeable events, investigators intentionally underestimating budgets, and limited budget assessment and oversight. Second, with the exception of a specific IICT funding program by the Swiss National Science Foundation, it was reported that limited funding sources and unrealistic expectation of funders led to underlying challenges in getting IICTs fully funded. A number of measures that could help reduce the underfunding of IICTs were identified, including improving the support of investigators and IICTs, strengthening networking and guidance, harmonizing and simplifying bureaucracy, and increasing public funding of IICTs.

CONCLUSIONS AND RELEVANCE

This study highlights the inadequate expertise of Swiss stakeholders to correctly, systematically, and reproducibly calculate RCT budgets and the need for transparency on trial costs as well as training in budgeting practices. Limited financial resources for academic clinical research and issues regarding the professional planning and conduct of IICTs are persistent issues that many other countries also face.

摘要

重要性

随机临床试验(RCTs)是评估医疗保健干预措施的重要方法,也是循证医疗保健的基石。然而, RCTs 变得越来越复杂和昂贵,这对独立研究者发起的临床试验(IICTs)尤其具有挑战性。IICTs 在临床研究中具有重要作用,因此必须努力确保 IICTs 得到充分资助,并以具有成本效益的方式进行。

目的

研究瑞士利益相关者在 IICT 资金获取和成本管理方面的做法和态度。

设计、设置和参与者:这项定性研究于 2020 年 2 月至 8 月在瑞士进行,采用了个体半结构式定性访谈。目的抽样包括来自 4 个不同群体的 48 名利益相关者:主要研究者(n=27)、资助者和赞助商(n=9)、临床试验支持组织(n=6)和伦理委员会成员(n=6)。

主要结果和措施

采用个体半结构化定性访谈评估利益相关者在 IICT 资金获取和成本管理方面的做法和态度。访谈使用常规内容分析进行分析。

结果

在对 48 名 IICT 利益相关者(75%为男性)进行访谈后,这些参与者发现 IICT 资金不足是一个系统性问题,这可能导致 IICT 质量和实施方面的妥协。参与者确定了瑞士 IICT 经常资金不足的两个相互关联的原因。首先,据报道,由于规划和准备不足、不可预见的事件、研究者故意低估预算以及有限的预算评估和监督,IICT 预算估算往往不准确。其次,据报道,除了瑞士国家科学基金会的一项特定 IICT 资助计划外,资金来源有限以及资助者的不切实际期望导致 IICT 获得全额资助的基本挑战。确定了一些可以帮助减少 IICT 资金不足的措施,包括加强对研究者和 IICT 的支持、加强网络和指导、协调和简化官僚主义以及增加对 IICT 的公共资助。

结论和相关性

这项研究强调了瑞士利益相关者在正确、系统和可重复地计算 RCT 预算方面的专业知识不足,以及需要对试验成本的透明度以及预算编制实践的培训。学术临床研究的有限财政资源以及 IICT 的专业规划和实施方面的问题是许多其他国家也面临的持续问题。

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