Roche Global Policy on Sharing of Clinical Trials Data
At Roche, we believe that transparency is critical to a business environment that is both productive and responsible. Clinical trial results from Roche sponsored studies have previously been reported on Roche-trials.com and ClinicalTrials.gov, as well as published in journals and at congresses. The expansion of the Roche Data Sharing Policy reflects a commitment by Roche to increasing transparency and sharing of clinical trial information. In developing this policy, we have taken a thoughtful approach that strikes a balance between our global corporate commitment to sharing data, while safeguarding patient confidentiality, and the regulatory process.
Universal data sharing is good for scientific advancement and increasing innovation. We are committed to, and enthusiastic about, the promise this offers science and society and the benefits greater openness could ultimately deliver to patients.
The Roche Data Sharing Policy is a global policy for both Roche and Genentech on the sharing of clinical trials data. This policy provides the opportunity to request and receive global clinical study reports (CSRs) and other summary reports. In addition, researchers may obtain access to analysable patient-level data from our clinical trials after their requests have been reviewed and approved by an independent panel of experts. Access will be approved by this independent panel on the basis of scientific merit. In both cases, data will be anonymised to respect the privacy of patients participating in our trials in accordance with relevant laws and regulations.
Requests for CSRs and other summary reports, as well as analysable patient-level data can be made on this website. Links to study results registries are also provided here.
- >Data Sharing Policy
- >Getting Started
- >Frequently Asked Questions
- >Submit Request for CSR or Other Study Information
- >Submit Request for Analysable Patient-level Data