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GSK announces data transparency initiative

In an effort to help improve data transparency in the pharmaceuticals industry, GlaxoSmithKline has made available to the public detailed summaries of more than 2,600 clinical trials conducted in 50 countries.

The information can be found in the GSK Clinical Trial Register (CTR), a database accessible through the home page of the company's website.

“We have created a record of transparency which we believe is unsurpassed in regard to medical interventions that affect the daily lives of patients,” said Frank Rockhold, senior vice president of biomedical data sciences at GSK R&D.

“The initiative to make healthcare information more widely available is growing as more pharmaceutical companies create results databases,” he continued .”It will progress further if not only more companies but also academic and government sponsors create public databases of the results of their research into various medical interventions.”

The GSK Register comprises clinical studies of all types (phases I-IV) that have been sponsored by GSK anywhere in the world since December 27, 2000, the date when the corporate merger creating GSK took effect.

The summaries are typically adapted for presentation in a format agreed by the International Conference on Harmonization (ICH), which represents industry and regulatory agencies in Europe, the US, and Japan.

GSK also reported that the number of visits to the GSK Register trended steadily upward through 2005 and early 2006, from 320 a day in the first quarter of 2005 to 920 a day in the first quarter of 2006.

GSK has also revised its standard contracts for co-development agreements so that, in the future, business partners will need to agree that trial summaries be posted to the GSK CTR under the current posting requirements.