Roche to launch publicly accessible databases for clinical trials
Enhanced transparency through electronic databases for clinical trial protocol registration and reporting of results
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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