Roche Statement

Another milestone in clinical data sharing: New system for requesting analyzable patient-level data begins on 1 January 2014

Basel, 2 January 2014

Roche announced today another milestone in our ongoing commitment to clinical trial data sharing. Researchers may now request access to analyzable patient-level data through www.clinicalstudydatarequest.com. Since June 2013, Roche has also provided access to Clinical Study Reports (CSRs) and other summary reports.

“We are now implementing the second phase of our data sharing policy, which provides researchers with access to patient-level data from Roche clinical trials. We worked hard to develop an approach that strikes a balance between our commitment to sharing data from our trials, while safeguarding patient confidentiality and the regulatory process,” said Michael Doherty, Roche Global Head of Regulatory Affairs. “We are enthusiastic about the promise this offers science and society, and the benefits greater openness could ultimately deliver to patients.”

Researchers may obtain access to analyzable patient-level data from Roche clinical trials after their requests have been reviewed and approved by an independent review panel on the basis of scientific merit. Data will be available for those clinical trials that have been submitted together with an application for a medicine’s registration and will be available after the completion of regulatory reviews in the United States and the European Union and for terminated programs.  Both the website www.clinicalstudydatarequest.com and the independent review panel are shared by other pharmaceutical companies including, to date, Boehringer Ingelheim, GSK, Sanofi and ViiV Healthcare.

CSRs and other summary reports that cannot be obtained via regulatory authorities are provided through www.roche-trials.com. Clinical trial protocols and summaries of results from Roche sponsored studies have previously been and continue to be registered and reported on ClinicalTrials.gov and www.roche-trials.com as well as published in journals and at congresses.

Both CSRs and analyzable patient-level data will be anonymized to respect the privacy of patients participating in our trials in accordance with relevant laws and regulations.

For additional information on the Roche data sharing policy, see www.roche.com.