Biomedical Research Integrity: Addressing Conflicts of Interest and Ethical Challenges in Clinical Trials.

IF 1.2 Q4 PHARMACOLOGY & PHARMACY
Ravindra Waykar, Yogesh A Kulkarni
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引用次数: 0

Abstract

This review examined the prevalence and implications of Conflicts of Interest (COI) in biomedical research. It involved an analysis of high-profile cases, including the Troglitazone safety controversy, Dr. Baselga's undisclosed pharmaceutical payments, National Institute of Health's (NIH) financial COIs, the COI involving COX-2 inhibitors, the 2008-2009 COI involving Harvard pediatric psychiatrists, and the UK University collaboration with "health-harming" industries. It also examined regulatory and ethical frameworks of COI management. The study's results show that COIs can threaten the quality of biomedical research and endanger patient health. In extreme cases, they might even lead to patient deaths. The evidence links this problem to the inconsistency of COI management policies, especially COI disclosure requirements. The findings of this research demonstrate the vague wording and poor enforcement of these requirements. To prevent the negative effects of COIs on research outcomes, consistent COI across relevant fields must be developed. For instance, leading academic journals must adopt the same COI disclosure approach to reduce ambiguity. Moreover, COI policies must address previously overlooked areas, such as the financial interests of authors' family members. The results of the study can be a good starting point for future research on addressing COIs through self-regulation. They illustrate the need for a customized COI management strategy rather than the one-size-fits-all approach.

生物医学研究诚信:解决临床试验中的利益冲突和伦理挑战。
本文综述了生物医学研究中利益冲突(COI)的普遍性及其影响。它涉及对备受瞩目的案例的分析,包括Troglitazone安全性争议,Baselga博士未公开的制药付款,美国国立卫生研究院(NIH)的财务COI,涉及COX-2抑制剂的COI,涉及哈佛儿科精神病学家的2008-2009年COI,以及英国大学与“健康危害”行业的合作。它还审查了COI管理的监管和道德框架。研究结果表明,coi会威胁生物医学研究质量,危害患者健康。在极端情况下,它们甚至可能导致患者死亡。证据表明,这一问题与COI管理政策的不一致有关,尤其是COI披露要求。这项研究的结果表明,这些要求的措辞模糊和执行不力。为了防止COI对研究成果的负面影响,必须在相关领域开发一致的COI。例如,领先的学术期刊必须采用相同的COI披露方法来减少歧义。此外,COI政策必须解决以前被忽视的领域,例如作者家庭成员的经济利益。研究结果可以为未来通过自我调节解决coi的研究提供一个良好的起点。它们说明需要定制的COI管理策略,而不是一刀切的方法。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Reviews on recent clinical trials
Reviews on recent clinical trials PHARMACOLOGY & PHARMACY-
CiteScore
3.10
自引率
5.30%
发文量
44
期刊介绍: Reviews on Recent Clinical Trials publishes frontier reviews on recent clinical trials of major importance. The journal"s aim is to publish the highest quality review articles in the field. Topics covered include: important Phase I – IV clinical trial studies, clinical investigations at all stages of development and therapeutics. The journal is essential reading for all researchers and clinicians involved in drug therapy and clinical trials.
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