丹麦欧登塞大学医院Lasse Østengaard团队研究了随机临床试验中利益冲突的影响和处理。该成果发表在2020年10月27日的《英国医学杂志》上。

为了描述和分析试验研究人员的经历，包括利益冲突如何过度影响他们所从事的临床试验，他们使用了什么管理策略来最小化潜在影响，以及他们在更普遍的利益冲突方面的经验和观点，研究组进行了一项定性访谈研究。

研究组招募至少参与10项临床试验并具有方法学或统计学专业知识的试验研究人员，他们因地理位置、教育背景和与不同类型的资助者打交道而经历不同。受访者通过Web of Science和滚雪球抽样搜索确定。研究组通过电子邮件联系了52名试验研究人员，其中20人同意接受采访。

受访者平均参加了37.5次试验，主要是有商业和非商业试验资助者经验的男性医师。研究过程中出现了两个预定义主题（利益冲突和处理策略的影响）和两个附加主题（利益冲突的定义和报告）。

可感知利益冲突影响的例子有：选择较差的对照组、操纵随机过程、过早地停止试验、捏造数据、阻止获取数据和歪曲（如对疗效进行过度有利的解释）。处理利益冲突的策略包括：公开程序、将资助方排除在设计和分析之外、独立委员会、确保完全获得数据的合同、资助方对分析和报告不设任何限制。

受访者对他们认为的利益冲突使用了不同的定义或阈值，他们对何时报告这些冲突描述了不同的标准。一些受访者认为，与商业性金融利益冲突（如由药品和器械公司资助）相比，非商业性金融利益冲突（如由具有政治议程的政府卫生机构资助试验）同等或更为重要，但报告和处理更具挑战性。

该研究描述了临床研究人员如何认识到利益冲突过度影响他们所从事的临床试验，以及他们为防止这些影响而采取的处理策略。研究结果表明，研究人员对利益冲突是什么以及何时应该报告的理解上，存在相当大的差异。

附：英文原文

Title: Influence and management of conflicts of interest in randomised clinical trials: qualitative interview study

Author: Lasse stengaard, Andreas Lundh, Tine Tjrnhj-Thomsen, Suhayb Abdi, Mustafe H A Gelle, Lesley A Stewart, Isabelle Boutron, Asbjrn Hróbjartsson

Issue&Volume: 2020/10/27

Abstract:

Objective To characterise and analyse the experiences of trial researchers of if and how conflicts of interest had unduly influenced clinical trials they had worked on, what management strategies they had used to minimise any potential influence, and their experiences and views on conflicts of interest more generally.

Design Qualitative interview study.

Participants Trial researchers who had participated in at least 10 clinical trials with methodological or statistical expertise. Researchers differed by geographical location, educational background, and experience with different types of funders. Interviewees were identified by searches on Web of Science and snowball sampling. 52 trial researchers were approached by email; 20 agreed to be interviewed.

Setting Interviews conducted by telephone, recorded, transcribed verbatim, imported to NVivo 12, and analysed by systematic text condensation. Semistructured interviews focused on financial and non-financial conflicts of interest.

Results The interviewees had participated in a median of 37.5 trials and were mainly male physicians who had experience with commercial and non-commercial trial funders. Two predefined themes (influence of conflicts of interest and management strategies) and two additional themes (definition and reporting of conflicts of interest) emerged. Examples of perceived influence of conflicts of interest were: choice of inferior comparator, manipulation of the randomisation process, prematurely stopping the trials, fabrication of data, blocking access to data, and spin (eg, overly favourable interpretation of the results). Examples of strategies to manage conflicts of interest were: disclosure procedures, exclusion of the funder from design and analysis, independent committees, contracts ensuring complete access to the data, and no restriction by the funder on analysis and reporting. Interviewees used different definitions or thresholds for what they considered to be conflicts of interest, and they described different criteria for when to report them. Some interviewees considered non-commercial financial conflicts of interest (eg, funding of trials by governmental health agencies with a political agenda) to be equally or more important than commercial financial conflicts of interest (eg, funding by drug and device companies), but more challenging to report and manage.

Conclusion This study described how trial researchers perceive conflicts of interest unduly influencing clinical trials they had worked on, and the management strategies they used to prevent these influences. The results indicated considerable variability in researchers’ understanding of what conflicts of interest are and when they should be reported.

DOI: 10.1136/bmj.m3764

Source: https://www.bmj.com/content/371/bmj.m3764