Roche offers researchers access to all Tamiflu trials
BMJ 2013; 346 doi: https://doi.org/10.1136/bmj.f2157 (Published 04 April 2013) Cite this as: BMJ 2013;346:f2157- Deborah Cohen
- 1BMJ
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 …
Log in
Log in using your username and password
Log in through your institution
Subscribe from £173 *
Subscribe and get access to all BMJ articles, and much more.
* For online subscription
Access this article for 1 day for:
£38 / $45 / €42 (excludes VAT)
You can download a PDF version for your personal record.