Roche to allow greater access to clinical trial data

Roche announced Tuesday that it is expanding access to clinical trial results for all of its licensed medicines and will make available data on any others upon specific request. "We understand and support calls for our industry to be more transparent about clinical trial data with the aim of meeting the best interests of patients and medicine," remarked chief operating officer Daniel O’Day.

Under the programme, Roche will work with an independent body to evaluate and approve requests to access anonymised patient-level data for clinical trials that have been submitted together with an application for a therapy’s registration. The drugmaker noted that the data will only be made available after the completion of regulatory reviews in the US and EU. Meanwhile, Roche indicated that it would support the release of full clinical study reports, summaries and safety updates for its approved medicines by the European Medicines Agency, but would edit the data to ensure patient confidentiality and to "protect legitimate commercial interests, including intellectual property rights." The drugmaker will also provide any report on request that cannot be obtained by the EMA for third party researchers starting in April.

Roche was previously criticised by the British Medical Journal and The Cochrane Collaboration for failing to release all data for its influenza therapy Tamiflu (oseltamivir). The drugmaker noted that it has published results for 71 of 74 completed trials and that it is arranging to release data from the remaining studies.

The move by Roche follows GlaxoSmithKline's announcement earlier this month that it would publish clinical study reports for all drugs dating back to the company's formation in 2000. The EMA also announced last year that it would take steps to increase access to clinical trial data.

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