制药巨头纷纷承诺公布临床试验数据

       制药巨头纷纷承诺公布临床试验数据 发布日期：2014-05-16  来源：firstwordpharma  
拜耳和勃林格殷格翰承诺将逐步公布其临床试验数据，最近包括诺华、强生、葛兰素史克、辉瑞、赛诺菲及罗氏在内的公司承诺了类似的计划。
根据计划，拜耳将授权有资格的研究人员获取该公司申办临床研究匿名患者水平的试验数据，范围包括该公司于今年1月及以后获美国或欧洲药品监管机构批准产品的试验数据。拜耳指出，它将通过门户网站提供数据，这符合欧洲制药工业协会联盟及美洲制药研究及生产商增加数据分享的承诺。
根据拜耳的计划，安全的数据获取要获得独立科学小组批准后才能许可。该公司表示，它不会参与小组的决策。“我们对临床试验透明度的承诺反映了我们促进科学研究及今后公众健康的意愿，”拜耳医疗保健全球开发主管Joerg Moeller如此评论说。
与此同时，勃林格殷格翰表明它将提供1998年以来的临床研究数据、及其它获批产品、药物开发项目中止后的临床研究相关文件。该公司强调，临床研究报告及其它文件将通过其专用网站申请，该网站的访问须获得独立外部审查小组批准后才能被授权。该制药商表示，这些承诺去年已经宣布，随着网站创建及回应申请的特别小组建立，目前这些承诺正在实施中。
此外，勃林格殷格翰证实了其在同行评议杂志及科学会议上发布其所有申办临床研究结果的承诺，包括所有类型的临床试验，不管其结果如何。“科学信息的免费交换是药物创新的基础，”勃林格殷格翰临床开发、药物及监管全球主管Christopher Corsico评论称，“我们认为这将是一个正确的途径，希望它能对科学发展带来帮助。”
Bayer, Boehringer Ingelheim expand access to clinical trial data
Bayer and Boehringer Ingelheim pledged to provide increased access to clinical trial data to the scientific community, following recent similar initiatives from companies including Novartis, Johnson & Johnson, GlaxoSmithKline, Pfizer, Sanofi and Roche.
Under its initiative, Bayer said it will grant access to anonymised patient-level data from company-sponsored clinical studies to qualified researchers for products that have been approved by US or European regulators on or after January 1 this year. Bayer noted that it will provide access through an internet portal in support of the European Medicine Agency's efforts to increase the transparency of data from clinical studies and in line with pledges by the European Federation of Pharmaceutical Industries and Associations and the Pharmaceutical Research and Manufacturers of America to increase data sharing.
Under Bayer's programme, secured data access will be granted after a research proposal is approved by an independent scientific panel. The company said that it will have no involvement in the decisions of the panel. "Our commitment to clinical trial transparency reflects our will to foster scientific research and hence public health," remarked Joerg Moeller, head of global development at Bayer HealthCare.
Meanwhile, Boehringer Ingelheim indicated that it will make available clinical study data and other clinical study related documents for approved products or after termination of a drug development programme for studies dating back to 1998. The company noted that clinical study reports and other documents will be requested through its dedicated website, with access granted after approval of a study protocol by an independent external review panel. The drugmaker stated that these commitments were announced last year, and are now being implemented with the creation of a website and formation of a dedicated team to respond to requests.
In addition, Boehringer Ingelheim confirmed its commitment to publish results from all sponsored studies in peer reviewed journals and at scientific meetings, regardless of outcome for all types of clinical trials. "The free exchange of scientific information is the basis for innovation in medicine," remarked Christopher Corsico, global head of clinical development, medicine and regulatory at Boehringer Ingelheim, adding "going beyond applicable regulatory and legal requirements, we...feel it is the right approach and hope it will benefit science."