GSK publishes patient-level data from vaccine trials

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.

- here's the database
- read the NEJM article (sub. req.)
- check out MedPage Today's take