EMA releases list of clinical trials missing results
The European Medicines Agency has released a list of drug trials that are missing results on the European trial registry, and “for which sponsors could not be reached or for which sponsors did not follow up on our request of results posting.”
According to the trial registry’s website:
“Following the issuing of the Joint Letter by the European Commission, EMA and HMA, National Competent Authorities and European Medicines Agency have sent reminders to sponsors who were not compliant with the European Commission guideline on results posting. Thanks to these reminders, the percentage of posted results substantially increased.”
“However, for some trials the reminders were not successful: detailed lists of these trials can be found here.”
In an email, the EMA press office explained that:
“Since September 2018, EMA has been regularly identifying trials with missing due results. EMA, together with the European Commission and the Member States, have been working on a number of actions to further improve the reporting rate in the EU Clinical Trials Register. EMA has substantially improved the EudraCT website and its instructions in order to make results reporting easier for academia and for commercial sponsors.”
“In addition, following the issuing of a joint letter reminding all sponsors of clinical trials conducted in the European Union of their obligation to make summaries of results of concluded trials publicly available, NCAs and EMA have sent reminders to sponsors who were not compliant with the European Commission guideline on results posting to increase compliance with the transparency rules and their follow up on their reporting obligations.”
“Thanks to these reminders, the percentage of posted results substantially increased. However, for some trials the reminders were not successful: many sponsors could not be reached.”
“For this reason and in order to be as much transparent as possible with the public, the list of trials for which sponsors could not be reached or for which sponsors did not follow up on our request of results posting is now published on https://www.clinicaltrialsregister.eu/.”
“Please note that the list includes most of the uncompliant trials but not all: for a few trials reminders were not sent yet or were sent only once, as they became uncompliant with the resulting posting guideline only very recently.”
Data from the EU Trials Tracker shows that between 2018 and now, the results reporting rate for drug trials in Europe has increased from 50% to 84%.
Currently, 3,055 clinical trials of investigative medicinal products are still verifiably missing results on EudraCT, the European trial registry.
Till Bruckner, founder of TranspariMED, said:
“The European Medicines Agency and many national drug regulators have made considerable efforts to improve clinical trial reporting in Europe, with remarkable success. The resulting increase in the availability of medical evidence will benefit patients and taxpayers across Europe, and will speed up the discovery of new treatments.”
“TranspariMED strongly welcomes the release of data on trials for which sponsors could not be reached, or for which sponsors did not follow up on regulators’ request of results posting.”
“Hopefully, the new CTIS registry for drug trials and the new EUDAMED database for medical device trials will in future also routinely make these kinds of data public, together with information on who sponsored non-compliant trials and which countries they took place in.”
EMA’s spreadsheet of trials missing results can be downloaded here.
TranspariMED encourages meta-researchers to dive into and further analyse these data.
For example, it would be extremely useful to know which countries these trials were conducted in, and which sponsors were involved, so that TranspariMED and other civil society groups can directly reach out to the stakeholders involved.