- Deborah Cohen
More than three years after the Cochrane Collaboration first asked Roche for the full clinical study reports for its influenza drug oseltamivir (Tamiflu), the Swiss company has offered the collaboration access to “all 74 Roche sponsored trials.”
Don MacLean, life cycle leader for Tamiflu at Roche, emailed the Cochrane researchers on 2 April to propose providing data in a staggered approach over the next few months.
“In line with European Union law, each CSR [clinical study report] will be edited by Roche to ensure patient confidentiality and to protect legitimate commercial interests,” he wrote.
A full phase III clinical study report typically consists of 2000 to 3000 pages, and redaction would be a “large undertaking,” he added.
The Cochrane group has cautiously welcomed the move, pointing out that Roche has previously promised access to data. MacLean’s email follows GlaxoSmithKline’s decision to release 30 clinical study reports on its influenza drug zanamivir (Relenza) to the …