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GSK公开专利级别疫苗研究数据

  1. GSK
  2. 数据共享
  3. 疫苗研究

来源:生物谷 2014-02-08 10:45

2013年8月3日讯 /生物谷BIOON/ --去年,葛兰素史克公司做出了一个史无前例的决定,将公司一些已经申请专利的疫苗临床研究数据公开,提供给独立的研究人员。十个月后,公司第一份数据已经出版。这一份数据包含了公司从2007年1月开始的研究数据,其内容包含了包括公司的麻疹疫苗、流行性腮腺炎疫苗、风疹疫苗以及水痘疫苗在内的多种疫苗。

2013年8月3日讯 /生物谷BIOON/ --去年,葛兰素史克公司做出了一个史无前例的决定,将公司一些已经申请专利的疫苗临床研究数据公开,提供给独立的研究人员。十个月后,公司第一份数据已经出版。这一份数据包含了公司从2007年1月开始的研究数据,其内容包含了包括公司的麻疹疫苗、流行性腮腺炎疫苗、风疹疫苗以及水痘疫苗在内的多种疫苗。研究人员只需要想葛兰素史克公司提交申请,经过审核后即可下载相关数据。(生物谷Bioon.com)

详细英文报道:

Last year GlaxoSmithKline ($GSK) made an unprecedented commitment to share patient-level clinical trial data with independent researchers. Ten months later, the first portion of the data is live, and vaccines are well represented.

The first batch of data covers the 211 interventional studies GSK has begun since January 2007. This includes data from trials for numerous vaccines, including GSK's measles, mumps, rubella and varicella (MMRV) vaccine, Priorix Tetra. Anonymized patient-level data from trials of vaccines to protect against pandemic H1N1 and H5N1, rotavirus and seasonal influenza is also available. To access the data, researchers must submit a proposal. Researchers cleared to view the data will be given access to standard statistical software--SAS and R--installed on GSK servers to run their analysis. They can then download the results.

Last month a leaked memo from the director general of European Federation of Pharmaceutical Industries and Associations (EFPIA) showed that the industry still has concerns about transparency. GSK has said it is committed to opening up its data, though. "We are taking this step because it is the right thing to do, both scientifically and for society, and it is in line with our company's commitment to transparency in clinical trial reporting," GSK SVPs Dr. Perry Nisen and Dr. Frank Rockhold wrote in the New England Journal of Medicine.

GSK is now seeking feedback on the first incarnation of the database, with a view to updating the site in September. At the same time GSK is adding more trials and expects the number of studies in the database to double by the end of the year. The ultimate goal is to add data from all interventional studies GSK has run since 2000, the year the company was formed in the $76 billion merger of Glaxo Wellcome and SmithKline Beecham.

 

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