Open Access News

News from the open access movement


Thursday, December 17, 2009

BMJ wants full clinical trial data

Fiona Godlee, We want raw data, now, BMJ, December 10, 2009.

This weekís BMJ is dominated by a cluster of articles on oseltamivir (Tamiflu). Between them the articles conclude that the evidence that oseltamivir reduces complications in otherwise healthy people with pandemic influenza is now uncertain and that we need a radical change in the rules on access to trial data. ...

Only after questions were put by the BMJ and Channel 4 News has the manufacturer Roche committed to making "full study reports" available on a password protected site. Some questions remain about who did what in the Roche trials, how patients were recruited, and why some neuropsychiatric adverse events were not reported. ...

The Cochrane reviewers have told the BMJ that they will update their review to incorporate eight unpublished Roche trials when they are provided with individual patient data. ...

We donít know yet whether this episode will turn out to be a decisive battle or merely a skirmish in the fight for greater transparency in drug evaluation. But it is a legitimate scientific concern that data used to support important health policy strategies are held only by a commercial organisation and have not been subject to full external scrutiny and review. It canít be right that the public should have to rely on detective work by academics and journalists to patch together the evidence for such a widely prescribed drug. Individual patient data from all trials of drugs should be readily available for scientific scrutiny.