Roche to launch publicly accessible databases for clinical trials

Enhanced transparency through electronic databases for clinical trial protocol registration and reporting of results

26-Jan-2005

Roche announced that it is establishing a global clinical trial protocol registry to disclose information about new Phase II to Phase IV studies at or before their start. In addition, the company will create a global clinical trial results database for key results from completed trials. The new registry and results database will enable the coordination of data Roche publishes and ensure that ultimately, there is one global source for all Roche-sponsored clinical trial data. Both the clinical trial registry and results database, which will be hosted by an independent, neutral entity, will be available to the public via a website by the end of the first quarter 2005. The name of the organisation will be announced in due time.

Ed Holdener, Head of Global Pharma Development at Roche, commented: "Transparency 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. Our 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."

The Roche approach is in accord with and even exceeds the information disclosure principles published earlier this year by the European Federation of Pharmaceutical Industry Associations (EFPIA).

The clinical trial registry will serve as a global repository for information on ongoing Phase II through Phase IV clinical studies. It will contain information in layman's terms about each trial to inform the public, in particular patients and healthcare professionals, as to the trial's purpose and conditions of participation. The clinical trial results database will ensure the fair and balanced reporting of all Roche-sponsored clinical trials that might affect the practice of medicine. Roche will also provide links to its global registry and database in local registries and databases, as appropriate and study results published in scientific journals will be referenced.

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