Roche Increasing Access to Clinical Trial Results

(FDA.gov)

The pharmaceutical company Roche, based in Switzerland, will increase access to its clinical trial data for third-party researchers. The company also promises access to clinical data for its flu medication Tamiflu, after review by independent scientists, for which the British medical journal BMJ and evidence-based medicine organization Cochrane Collaboration have long-standing requests for access.

In a statement released yesterday, Roche promised access to full clinical study reports for all of its licensed medicines through regulatory authorities, and to provide access on request by researchers to reports that regulatory authorities cannot provide. The company, says the announcement, also supports release of its clinical study reports by the European Medicines Agency, which the agency is expected to begin next year.

The company adds that an independent body of experts will review for scientific validity researcher requests to complete, anonymous patient-level data sets from its clinical trials, submitted for regulatory review in the U.S. and Europe. Roche says the independent review process will go into effect this year, and the company will seek to make it a standard practice in the pharmaceutical industry.

Roche has been criticized by BMJ and Cochrane Collaboration for not releasing all of its clinical studies of Tamiflu, with some unmet requests going back as far as September 2009. The company says results of 71 of 74 completed Tamiflu trials have been released either in publications or on its Web site rochetrials.com. Arrangements are being made, says Roche, to post the three remaining completed trials.

Roche says a committee will be formed by four scientists in the field of influenza to review the Tamiflu data, identify unanswered questions, and agree on a statistical analysis plan. The four scientists forming the review committee are Albert Osterhaus at Erasmus Medical Centre in Rotterdam, Menno De Jong at Academic Medical Centre in Amsterdam, Arnold Monto at University of Michigan, and Richard Whitley at University of Alabama. The committee is scheduled to meet in June.

Roche’s action follows a similar announcement by GlaxoSmithKline in October 2012 to make available its clinical trial data. In September 2012, 10 pharmaceutical companies, including Roche’s Genentech subsidiary and GlaxoSmithKline, started an organization called TransCelerate BioPharma to improve the way clinical drug studies are conducted. Among that group’s projects are a shared user interface for investigator site portals and development of clinical data standards.

Read more:

• Clinical Trials To Test More Tamiflu Effects, Plasma on Flu
• Weill Cornell, N.Y. Hospital Open Precision Medicine Center
• Statistical Tools Sought for Smaller Placebo Group Sizes
• GlaxoSmithKline to Open its Clinical Trial Data
• Pharmas to Collaborate on Improving Clinical Trial Process

*     *     *