EMA Looks to Open Up Clinical Trial Data After Concerns About Tamiflu Raised
Posted 11 April 2012 | By
The European Medicines Agency (EMA) announced it is looking to develop a "way forward for publication of full clinical trial data" after concerns were published about selective publication of Tamiflu efficacy data.
Tamiflu, which was stockpiled heavily around 2009 due to fears about swine flu, was recently attacked in the medical journal PLoS Medicine by authors Peter Doshi, Tom Jefferson and Chris Del Mar, who claim the drug overstated its effectiveness by hiding certain clinical trial results from numerous agencies.
Jefferson and Doshi authored a scathing opinion piece in the New York Times on 10 April reiterating their concerns, saying they found the drug to be "no more effective than aspirin" at treating the influenza virus.
EMA officials, including Executive Director Guido Rasi, authored a PLoS Medicine article in response entitled, "Open Clinical Trial Data for All? A View from Regulators."
In the article, the EMA officials argue that "clinical-trial data should not be considered commercially confidential and that open access could also lead to public-health benefits through independent analysis and the development of predictive models."
While they warn there is a risk of breaches of patient confidentiality as a result of the full datasets being published, these risks can be mitigated by establishing "rules of engagement for sharing raw data."
EMA - European regulators propose way forward for publication of full clinical trial data
PLoS Medicine - The Imperative to Share Clinical Study Reports: Recommendations from the Tamiflu Experience
PLoS Medicine - Open Clinical Trial Data for All? A View from Regulators
New York Times - Drug Data Shouldn't Be Secret
PM Live - EMA calls for open access to clinical trial data after Tamiflu concerns