Here’s how EMA can make clinical trial results reporting easier for universities
Since 2014, it has been mandatory for companies and universities running clinical trials of medicines to upload their results onto the European trial registry, which is managed by the European Medicines Agency.
However, most European universities have uploaded less than ten percent of their results. Small and mid-sized companies also have low compliance rates. According to the EMA’s own figures, 5,855 trials are currently missing results.
The resulting gap in the evidence base for medicines harms patients, undermines public health, and contributes to the increasing strain that health care expenditures are placing on EU Member States' budgets.
Universities report that shortcomings in the registry’s design and management by EMA form significant barriers to improving compliance.
In its dual role as medicines regulator and platform manager, the EMA has the mandate, the power and the obligation to remove these barriers.
TranspariMED has shared this list of barriers with the EMA, and asked it to address them.(See also this recent survey.)
Universities that want to improve their clinical trial reporting can find a collection of transparency tools, tips and tricks on the TranspariMED website.
Note on methodology: A draft list of items was compiled by TranspariMED based on interviews with UK registry managers, a previous policy paper on the topic, a guest blog for TranspariMED, presentations and conversations at a recent trial reporting workshop in Berlin convened by the BIH QUEST Center, and workshop slides (available here). Two experienced trial registry managers from UK universities then reviewed and expanded the list, and scored the impact of each item based on their personal experiences with uploading trial results.