Roche opens access to analysable patient-level data

Roche has announced the launch of a new system for requesting analysable patient-level data, as part of its continuing commitment to clinical data sharing.

Researchers may now request access to this information through the website www.clinicalstudydatarequest.com. These applications are then reviewed and approved by an independent review panel on the basis of scientific merit.

Data will be made available for terminated programmes and clinical trials that have been submitted together with an application for a medicine's registration, but only after the completion of regulatory reviews in the US and Europe.

This website and independent review panel are also being used by several other companies on their data-sharing initiatives, including Boehringer Ingelheim, GlaxoSmithKline, Sanofi and ViiV Healthcare.

Michael Doherty, Roche's global head of regulatory affairs, said: "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."

This comes as part of a wider process initiated by Roche last year to be more transparent about clinical trial data and make its findings more accessible to third-party researchers.