Roche is committed to sharing data from clinical trials and has registered and posted summary reports for trials involving patients on clinicaltrials.gov and on roche-trials.com since 2005. Alongside this posting, we actively seek presentation and publication of our clinical trial data at scientific congresses and in peer-reviewed journals.
Continuing this theme of openness and transparency, Roche announced a new policy regarding clinical trial information sharing in February 2013, expanding access to clinical study reports (CSRs), periodic safety reports, clinical trial summary reports, and analysable patient-level data from our trials.
Roche is supporting the release of CSRs, periodic safety reports, and clinical trial summary reports for all licensed, terminated or discontinued medicines by regulatory authorities and will provide any CSR, periodic safety report, or clinical trial summary report on request that cannot be obtained from regulators. In order to respect patient privacy, no identifiable data will be disclosed.
Alongside this commitment, Roche will establish an independent body of recognised experts to assess the scientific validity of requests for anonymised patient-level data, with the requested data made available within a secure system following agreement. Access will be based on good scientific merit that will help patients and doctors in using our medicines.
At Roche, we agree that high quality analysis of clinical trial data by scientific researchers can broaden knowledge about our medicines and benefit patients and public health. The expansion of our policy is a global commitment to increasing transparency surrounding data from our clinical trials, while ensuring that patient confidentiality and commercially confidential information is protected.
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