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Pharma to publish data

Pharmaceutical companies around the world have agreed to make all their clinical trial data freely available.

Pharmaceutical companies around the world have agreed to make all their clinical trial data freely available.

The move follows increasing pressure from both regulators and the public to make the results of clinical trials available, with many recent media reports surfacing concerning the safety of well-known drugs.

The web-based databases will include the results of all industry-sponsored clinical trials on medicines that have been approved for marketing and which evaluate their safety and benefit. Details of clinical trials being conducted to determine a medicine's therapeutic benefit will also be included.

Brian Ager, director general of the EFPIA said: ìBy making public not just the results of trials that have taken place - whether positive or negative - but also information on those that are just starting, the industry has made a major step towards achieving greater transparency.î

The results will appear in a standard, non-promotional summary which will include a description of trial design and methodology, results of primary and secondary outcome measures described in the results, and safety results.

Web links will be provided for results that have already appeared in peer review journals. However, phase I clinical trial results will not be published on the databases in order to protect pharma companies from competition.

UK health minister Lord Warner, who last year sent a letter to the Association of the British Pharmaceutical Industry demanding to know why companies had failed to make their clinical trial results available, welcomed the decision.

ìIt is for the whole industry to take forward practical measures giving effect to this agreement speedily, especially given the context of the global initiative on clinical trials discussed at the Mexico health research summit in November,î he said.

Pharma companies in the UK have already started efforts to publicise their trial results. The ABPI launched a database in 2003, followed by GSK in June 2004 and Eli Lilly last month.

The initiative was drawn up and agreed by the European Federation of Pharmaceutical Industries and Associations (EFPIA), the International Federation of Pharmaceutical Manufacturers' Associations, the Japanese Pharmaceutical Manufacturers' Association and the Pharmaceutical Research and Manufacturers of America.

30th September 2008

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