New EU rules on clinical trials data aimed at preventing Tamiflu and other scandals

15 April 2014

New rules on making clinical trials data available for public scrutiny were voted through by the European Parliament this month.

Last week the Cochrane Collaboration and the BMJ published a new analysis of the effectiveness of Tamiflu, that revealed it only shortened symptoms of flu by half a day and did not reduce admissions to hospital or complications.

Labour MEP Glenis Willmott said, "The news about Tamiflu highlights just how urgently we need full transparency of clinical trial data. Currently around half of all clinical trials are not published, which is unacceptable. Negative results are less likely to be reported than positive results — with Tamiflu a case in point.

"This legislation passed by the European Parliament last week will change that by ensuring all trials report a summary of results to a publicly accessible database, as well as the full clinical study reports once a medicine has applied for authorisation."

The legislation includes the creation of a publicly accessible clinical trials database. All trials in the EU must be registered on the database, a summary of results must be uploaded one year after the end of the trial, and the full clinical study reports must be uploaded if a medicine is submitted for marketing authorisation.

Glenis Willmott added: "The current situation can lead to unnecessary or dangerous trials being repeated, and can give a biased picture of the safety and efficacy of the medicines we are prescribed.

"Finally patients, doctors and researchers will have access to the results of all clinical trials; positive, negative and inconclusive. That's good for patient safety, good for scientific progress and good for public trust in medicines.

"We have seen from the US, where financial penalties are not enforced, that transparency rules are often disregarded. We do not want the same situation here in Europe. The new law will also support the European Medicines Agency's transparency policy, and help ensure data from old trials is also published."

The new transparency measures will apply to all future trials, with the regulations including a clear statement Clinical Study Reports should not be seen as commercially confidential, which will be vital in supporting the European Medicines Agency as they try to publish the data they hold on old trials.


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