行业资助的临床试验:有益还是有害?

Jing Zhang, Yiping Yuan
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引用次数: 3

摘要

临床试验是评价新药和其他医疗技术有效性和安全性的金标准手段。它们可以为患者及其护理人员的治疗决策提供科学依据,也可以为政府和保险公司提供合理的报销政策。在过去的十年里,临床试验的组织发生了从政府和学术界到工业界的巨大转变。目前,大多数试验是由工业界资助的,他们的研究确实对生物医学创新做出了巨大贡献,尽管局限性是不可避免的。研究发现,行业赞助与实验治疗结果密切相关,这给临床试验结果带来了赞助偏见和质量问题的担忧。然而,现有的研究有其自身的局限性,并且没有确凿的因果关系证据。行业资助的临床试验是一把双刃剑,鼓励对赞助偏见进行进一步研究。更强有力的监管政策和学术界与工业界之间的新联盟模式也势在必行。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Industry-funded clinical trials: Beneficial or harmful?
Abstract Clinical trials are the gold-standard means to evaluate the efficacy and safety of new drugs and other medical technologies. They can provide a scientific basis for treatment decisions for patients and their caregivers as well as sound reimbursement policies for governments and insurers. There has been a spectacular shift from government and academia to industry in the organization of clinical trials in the past decade. Currently, most of the trials are funded by industry and their research does make great contributions to the biomedical innovations, although limitations are inevitable. The finding that industry sponsorship is strongly associated with results that favor the experimental therapy brings concerns of sponsorship bias and quality issues to clinical trial results. However, existing research has its own limitations, and there is no solid evidence of causality. Industry-funded clinical trials are a two-edged sword, and further research on sponsorship bias is encouraged. A stronger regulatory policy and a new model of alliance between academia and industry are also imperative.
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