{"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":null,"pages":null},"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\":null,\"pages\":null},\"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}
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.