行业资助的临床试验:有益还是有害?

Jing Zhang, Yiping Yuan
{"title":"行业资助的临床试验:有益还是有害?","authors":"Jing Zhang, Yiping Yuan","doi":"10.3109/10601333.2015.1078809","DOIUrl":null,"url":null,"abstract":"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.","PeriodicalId":10446,"journal":{"name":"Clinical Research and Regulatory Affairs","volume":"46 1","pages":"109 - 112"},"PeriodicalIF":0.0000,"publicationDate":"2015-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"3","resultStr":"{\"title\":\"Industry-funded clinical trials: Beneficial or harmful?\",\"authors\":\"Jing Zhang, Yiping Yuan\",\"doi\":\"10.3109/10601333.2015.1078809\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"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.\",\"PeriodicalId\":10446,\"journal\":{\"name\":\"Clinical Research and Regulatory Affairs\",\"volume\":\"46 1\",\"pages\":\"109 - 112\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2015-10-02\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"3\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinical Research and Regulatory Affairs\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.3109/10601333.2015.1078809\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical Research and Regulatory Affairs","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.3109/10601333.2015.1078809","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
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。
查看原文
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
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.
求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
自引率
0.00%
发文量
0
期刊最新文献
Changes to protocol in the regulation of adverse drug reactions – historical and current European view Policy and regulations in light of the human body as a ‘superorganism’ containing multiple, intertwined symbiotic relationships Community pharmacists’ knowledge and perceptions on risk management plans in the Southern Region of Portugal Increasing the odds of effective drug development: Elevating regulatory affairs professionals to strategic partners Current regulatory challenges and approaches in the registration of herbal drugs in Europe
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
已复制链接
已复制链接
快去分享给好友吧!
我知道了
×
扫码分享
扫码分享
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1