Roche trials database

Welcome to the Roche clinical trial protocol registry and results database site. Roche is committed to ensuring transparency of information related to its clinical trial protocols and also the reporting of clinical trial results. This protocol registry and results database will enable the coordination of the data Roche publishes and ensure that ultimately, there is one global source for Roche-sponsored clinical trial data for both patients and health care professionals.

The goal of the Roche approach is in accord with and is intended to comply with or exceed, the information disclosure principles in the "Joint Position on the Disclosure of Clinical Trial Information Via Clinical Trial Registries and Databases", as published by the European Federation of Pharmaceutical Industry Associations (EFPIA), the International Federation of Pharmaceutical Manufactures and Associations (IFPMA), the Japanese Pharmaceutical Manufacturers Association (JPMA), and the Pharmaceutical Research and Manufacturers of America (PhRMA).

Roche has always been dedicated to transparency in clinical trials and publishes both positive and negative results of late stage development trials. The company is committed to creating and maintaining both a clinical trial registry to help patients, their caregivers and physicians find clinical trials that may be appropriate for them, and a results database to ensure health care providers, patients and their caregivers have ready access to study results.

The registry and results database will be populated with Roche clinical trials that fit the criteria listed below. Once a trial is listed in the registry it will never be removed. Any trial listed in the registry will have a corresponding entry in the results database, regardless of the outcome of that trial.

The following criteria are used for posting trials in the registry and the results database:

• The registry will be populated with all planned and active Pharmaceuticals and Diagnostics Roche-sponsored interventional trials (as of October 1, 2004), and all Phase I studies in patients (as of December 1, 2006), that have received IRB / IEC or Competent Authority approval, i.e. Roche will post all Phase I studies in patients and all Phase II-IV trials.
• The results database will be populated with:
  • All Roche-sponsored interventional Phase I trials in patients completed after December 1, 2006 on any approved product;
  • All Roche-sponsored interventional Phase II-IV trials completed after October 1, 2002 on any approved product;
  • All retrospective Roche-sponsored interventional phase II-IV trials completed for products that received first approval in first indication after October 1, 2002;
  • Diagnostic interventional clinical trials completed after October 1, 2002 on any advanced diagnostic product;
  • Results will be published within 1 year of trial completion (unless restricted by journal publication timing or pending regulatory filing).

The registry and results database will house all Roche-sponsored trials that fit the above criteria. Roche will continue to post information on a regular basis. In some cases Roche drugs may be used in studies that are sponsored by other entities. Under such circumstances and if practical, Roche will attempt to direct users to any additional clinical trial registry and results information that is available.

In addition, this website is also intended to be a resource for patients and physicians interested in information about clinical trials. Therefore, the website contains information about the clinical trial process and a listing of key definitions and useful terminology.

In addition to posting all Roche-sponsored clinical trials meeting the above criteria on this website, as of the end of 2006 Roche also registers these protocols on ClinicalTrials.gov - the registry managed by the National Institutes of Health in the US. Protocols may also be registered in other registries if required by local regulations.

This website can be accessed directly via www.roche-trials.com, or via the corporate Roche website (www.roche.com). In addition, the data held on the Roche website can be accessed via the IFPMA portal (clinicaltrials.ifpma.org), which links to IFPMA member company websites as well as other commercial and government sponsored websites containing information on clinical trials provided by pharmaceutical companies.

Please enjoy the use of this website.