[Ip-health] Press release: European Universities' alarmingly low compliance with EU clinical trial transparency regulations leaves students concerned

Sabrina Wimmer sabrina.wimmer93 at gmail.com
Fri Sep 14 04:08:42 PDT 2018


Dear all,

Universities Allied for Essential Medicines (UAEM) has issued a statement
responding to Ben Goldacre's article on the compliance of reporting
clinical trial results published in the BMJ yesterday.

Let us know if you have any questions.

Best wishes,
Sabrina Wimmer


PRESS RELEASE

Issued: Friday 14 September 2018

European Universities' alarmingly low compliance with EU clinical trial
transparency regulations leaves students concerned

Half of EU clinical trials have failed to meet the requirement to report
results, according to a study published in the British Medical Journal on
Thursday. Universities perform especially poorly, with only 11% of clinical
trials being reported on average.

Most European universities aspire to conduct scientific research in
accordance with international best practices, however, they fall short of
this standard when it comes to clinical trial transparency. A new study by
Ben Goldacre from the University of Oxford reveals that results for almost
half of all clinical trials conducted in the EU never get published.
Universities perform particularly poorly, with a mere 11% of their clinical
trials results being reported on the European Clinical Trials Registry.1

“As university students, we are deeply disappointed with the findings of
this study. We are taught about the importance of evidence-based medicine
and good scientific practice, while our universities themselves clearly do
not comply with these principles when it comes to publishing their clinical
trial results. It concerns us that in the current intransparent
environment, doctors cannot be certain to provide the best care possible to
their patients", said Sabrina Wimmer, medical student at the University of
Groningen in the Netherlands.

Failure to publish results directly harms patients as doctors cannot be
sure that the treatment they are prescribing is truly effective if half the
data is missing. Furthermore, it can make drugs seem more effective than
they really are. This leads to health systems paying more for newer, more
expensive drugs that have no or little benefit compared to much cheaper
drugs, thus creating financial burdens and limiting access to truly
effective medicines.

Although universities may argue that they publish findings in academic
journals, aside from it being against EU regulations, researchers have
found that the results data published on registries is more reliable and
include important details about safety which are omitted from journal
articles.2

We call on all European universities to:

   1.

   Publish all their missing trials results on the EU Clinical Trials
   Register (EU CTR)
   2.

   Sign onto the World Health Organisations Joint Statement on Clinical
   Trial Transparency, to publicly show their commitment to adequate clinical
   trial

   transparency
   3.

   Create a university taskforce with the responsibility to ensure that
   principal

   investigators of future trials post their results within 12 months of
   trial completion.


1 https://www.bmj.com/content/362/bmj.k3218
2
https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.100156



-- 
*Sabrina Wimmer*

European Coordinator (ECC)
Universities Allied for Essential Medicines (UAEM)
*E:* *sabrina.wimmer93 at gmail.com <sabrina.wimmer93 at gmail.com>*
*P: *+31 634744473


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