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Roche to publish data

Roche has become the latest pharmaceutical company to set up its own clinical trials database.

Roche has become the latest pharmaceutical company to set up its own clinical trials database.

The Swiss pharma company said that it would establish a clinical trials database to display key results from completed clinical trials. This, Roche said, would ensure fair reporting of all Roche-sponsored trials that might affect the practice of medicine.

Links to a global registry and database, local registries and references to results published in scientific journals will also be included in the database.

In addition, a clinical trials protocol registry will be created to provide information on phase II to phase IV trials before they are conducted. The registry is expected to include information in layman's terms on all the trials so that patients can understand their purpose and conditions.

Data posted on the sites will include any phase II-IV trial completed on or after October 1, 2004 and for products marketed on or after October 2, 2002.

Roche hopes the sites will be hosted by an independent organisation and be available by the end of the first quarter of 2005.

Ed Holdener, head of global pharma development at Roche said: ìTransparency on the results of its clinical studies has always been important to Roche. At the same time, it is important that we protect the safety and the rights of patients and secure the quality and integrity of the data and related conclusions.

ìOur current policy on the publication of clinical trial data will be further enhanced and consolidated by the creation of one electronic source of information. This clear and transparent approach is in the best interest of all parties involved,î he added.

Roche's decision to publish its results follows an initiative agreed earlier this month by a group of pharmaceutical associations to make all clinical trial data freely available. It is hoped the measure will go some way to ensuring greater transparency following recent media reports concerning the safety of well-known drugs.

The Association of the British Pharmaceutical Industry, GlaxoSmithKline and Eli Lilly & Company have already set up their own databases.

30th September 2008

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