Ed Holdener, Head of Global Pharma Development at Roche, said: “We are proud to go live with our publicly accessible protocol registry and clinical trial results database today. Transparency has always been and continues to be a priority for us. In January, we announced our plans to have an independent host for the database and since then, we selected CenterWatch, a company with a wealth of experience in the area of data management and the publication of clinical trial information. So for the first time ever, there is now a global and publicly accessible database, containing comprehensive information about Roche’s clinical trials?
Roche expects that the huge task of publishing data from more than 30 medicines, on a product by product level from a large number of global and local trials, will take approximately a year. Roche will also continue to contribute information to established databases (i.e. www.clinicaltrials.gov)
Information that can be found in the electronic database
Starting with Fuzeon and Bondronat, clinical trial information will be added in a staged approach on the databases and will ultimately include protocol information and results from all Phase II to Phase IV clinical trials completed after 1 October, 2004. In addition, data from all Phase II to Phase IV clinical trials for medicines first marketed after 1 October, 2002 will be included retrospectively. The clinical trial registry and results database will also include interventional clinical studies from Roche Diagnostics.< /p>
Roche approach and possible industry solution
Roche is taking a leadership role in the industry’s efforts to ensure transparency with its global approach, which is consistent with the information disclosure principles published earlier this year by the European Federation of Pharmaceutical Industry Associations (EFPIA).
The Roche strategy may model an industry-wide solution. Roche would support and participate in a future industry solution that provides a public database in which all companies can publish both national and international protocol information and trial results. Roche would be delighted if this independent solution would lead other pharmaceutical companies to use the CenterWatch repository to register ongoing clinical trials and report results of trials.
CenterWatch is a leader in web design and experienced in the implementation of websites for clinical trial listings and clinical trial results, and already has an established reputation as an independent source that the public trusts for clinical trial listings and results. Having CenterWatch host Roche’s clinical trials databases provides the widest possible exposure, and makes it easy for the public to obtain important information in this area.
Strict adherence to regulations of clinical trials
Roche works to ensure that all its activities are performed in accordance with ethical and regulatory requirements. Moreover, Roche is strongly committed to verifying adherence to compliance policies. Adequate and ongoing peer review is a key prerequisite for maintaining high ethical standards in Roche’s clinical trials and development activities.
In addition, Roche adheres to the “Declaration of Helsinki? a statement developed by the World Medical Association on ethical principles to provide guidance to physicians and other participants in medical research involving human subjects. Roche also strictly follows the rules of good clinical practice (GCP), which ensure the protection of patients?safety and rights.