研究人員對隨機臨床試驗中利益衝突的影響和處理存在較大差異
作者：
小柯機器人發布時間：2020/11/4 15:39:01
丹麥歐登塞大學醫院Lasse Østengaard團隊研究了隨機臨床試驗中利益衝突的影響和處理。該成果發表在2020年10月27日的《英國醫學雜誌》上。
為了描述和分析試驗研究人員的經歷，包括利益衝突如何過度影響他們所從事的臨床試驗，他們使用了什麼管理策略來最小化潛在影響，以及他們在更普遍的利益衝突方面的經驗和觀點，研究組進行了一項定性訪談研究。
研究組招募至少參與10項臨床試驗並具有方法學或統計學專業知識的試驗研究人員，他們因地理位置、教育背景和與不同類型的資助者打交道而經歷不同。受訪者通過Web of Science和滾雪球抽樣搜索確定。研究組通過電子郵件聯繫了52名試驗研究人員，其中20人同意接受採訪。
受訪者平均參加了37.5次試驗，主要是有商業和非商業試驗資助者經驗的男性醫師。研究過程中出現了兩個預定義主題（利益衝突和處理策略的影響）和兩個附加主題（利益衝突的定義和報告）。
可感知利益衝突影響的例子有：選擇較差的對照組、操縱隨機過程、過早地停止試驗、捏造數據、阻止獲取數據和歪曲（如對療效進行過度有利的解釋）。處理利益衝突的策略包括：公開程序、將資助方排除在設計和分析之外、獨立委員會、確保完全獲得數據的合同、資助方對分析和報告不設任何限制。
受訪者對他們認為的利益衝突使用了不同的定義或閾值，他們對何時報告這些衝突描述了不同的標準。一些受訪者認為，與商業性金融利益衝突（如由藥品和器械公司資助）相比，非商業性金融利益衝突（如由具有政治議程的政府衛生機構資助試驗）同等或更為重要，但報告和處理更具挑戰性。
該研究描述了臨床研究人員如何認識到利益衝突過度影響他們所從事的臨床試驗，以及他們為防止這些影響而採取的處理策略。研究結果表明，研究人員對利益衝突是什麼以及何時應該報告的理解上，存在相當大的差異。
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