A new article published in Trials reports that the European Medicines Agency’s system of releasing clinical trial documents may involve lengthy correspondence, and significant time delays.
In 2010, the European Medicines Agency (EMA) introduced a new policy to make detailed clinical trial information available on request. Between 2011 and 2015, the authors of the Trial study made 12 separate requests to the EMA for information, relating to 118,000 pages of data on 29 different drugs.
They found that the process of requesting information is complex, and over time the EMA’s response times have got longer.
Dr Tom Jefferson, Centre for Evidence Based Medicine, co-author of the study said:
“Given the growing recognition of regulatory data as the key to unlocking reporting bias in the scientific literature, the EMA’s system needs to be straightforward.”
“Accessible data from experiments on humans remains an aspiration, it’s not here yet”
The authors make practical suggestions on how the process can be made more efficient, but are keen to stress the EMA’s approach, whilst slow, is still the most transparent of the world’s regulators:
“Despite the problems, the EMA’s unique efforts should not be undermined. Independent researchers and users should instead support the policy as at present it is the most promising way to address reporting bias in literature”
“The EMA is trying to do the right thing for science, for medicine and especially for the patients they serve. That is precisely why it is worth fighting to improve EMA practice, perhaps with more resources and regular open audits.”