Roche trials database

Roche Global Policy on Registration of Clinical Trial Protocols and Publication of Clinical Trial Results

Roche believes it has an ethical obligation to ensure that results of all clinical trials which are likely to have scientific or medical significance are available to the medical community. Therefore, Roche will participate in both a clinical trial protocol registry to disclose certain details of new studies at or before their inception, and a clinical trial results database to publish key results from completed trials.

The goals of this policy are two-fold:

1. To assist patients, in consultation with their physicians, to find clinical trials that may be appropriate for them (in the clinical trial protocol registry);
2. To make a balanced view of clinical trial results available to practicing physicians and other health care professionals in a format that is both readily accessible and comprehensible (in the clinical trial results database).

The key features of the proposed registry and database are described in this policy document and the associated supporting documents - frequently asked questions and the definition of the end of a trial.

Roche's approach is in alignment with the global industry position on disclosure of clinical trial information published by the European Federation of Pharmaceutical Industries and Associations (EFPIA), the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), the Japanese Pharmaceutical Manufacturers Association (JPMA) and the Pharmaceutical Research and Manufacturers of America (PhRMA). (Global Industry Position position PDF)

General Considerations in Clinical Research

Roche has pledged to comply with the following principles in clinical research:

• WHO Good Clinical Practice (GCP) guidelines: All Roche-sponsored clinical trials using Roche pharmaceutical products are conducted according to these guidelines. Regular training sessions for Roche employees ensure a high standard of quality.
• Roche provides clinical trial materials free of charge to patients participating in Roche trials. If the health of these patients improves during treatment, they will continue to receive the trial medication after the trial is completed. If the provision of free medication cannot be ensured following termination of a clinical trial, Roche undertakes to work with local health authorities or other institutions to find a solution that will at least ensure provision of medication at reduced cost.
• Roche is committed to protecting the privacy of patients participating in Roche-sponsored clinical trials to avoid stigmatization of such patients and violations of their personal data protection rights and to comply with the law.
• Where the results of a clinical trial in a developing country are used to obtain regulatory approval for a pharmaceutical product in another country, Roche will apply for marketing authorization for the product in the developing country.
• When conducting clinical studies in developing countries, Roche is committed to working with local investigators, and respecting local laws and customs, provided such laws and customs do not compromise patient safety, human rights and dignity, ethical principles or Good Clinical Practice standards.
• In conducting clinical trials in developing countries, Roche works within local healthcare systems in a manner that does not overburden such systems.
• Ethical considerations occupy an important place in the development of new drugs. The Pharmaceuticals Division has a broad-based program set up to ensure that Roche employees are constantly reminded of the company's corporate values and ethical standards in their daily work. This allows ethical issues to be addressed proactively and promotes a broad consensus on the values that should guide our activities. These values offer a clear frame of reference, providing reassurance and thus motivation.
• Global Roche Position on Human Subject Research, February 2004.