New EU rules on clinical trials data aimed at preventing Tamiflu and
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
"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.