Roche ($RHHBY) has taken a lot of flak for withholding clinical trial data. The BMJ and others spent years trying to get Roche to release Tamiflu data, and the criticism continued even after the Swiss pharma put in a new results-sharing policy. Now, Roche is facing a situation where sharing trial data may be the best way to clear up the effect of Avastin on brain cancer.
The company is considering sharing raw clinical trial data with a group of outside investigators to learn why two studies reached opposite conclusions. A Roche-sponsored study published in The New England Journal of Medicine found that Avastin improved or maintained quality of life and brain function in patients with glioblastoma, a cancer. Yet the independent trial found no improvement among patients who received the drug. Roche needs to clear up the discrepancy if it is to convince regulators and payers that Avastin should form part of the initial treatment of glioblastoma.
First, Roche must work out why the trials reached different conclusions. "Is the outcome different just because they used different statistical methodologies? You can apply different statistical tests and get very different statistical answers," Howard Fine, deputy director of the New York University Cancer Institute, told Bloomberg. Fine wasn't involved with either study but has led previous research on the use of Avastin to treat brain cancer. In an editorial published in the NEJM, Fine said the differences between the studies are "neither trivial nor academic."
Delving into the raw data is the best way to learn whether the differences are the result of a statistical quirk or something more significant. Roche is already talking to the team behind the independent study and is also discussing the results with the FDA. The U.S. regulator's accelerated approval of Avastin in glioblastoma patients required Roche to provide trial data showing the clinical benefit of the treatment by the end of 2015.
- here's the Bloomberg article
- check out FiercePharma's take
Industry Voices: Clinical trial transparency--time for some carrot as well as more stick?