The European Medicines Agency has announced plans to make it easier for universities and smaller pharma companies to upload the results of clinical trials of medicines onto the European trial registry EudraCT.
Posting results of onto the registry has been mandatory since 2014, but many institutions running clinical trials are violating this transparency rule, leaving large gaps in the medical evidence base and fuelling research waste. A key reason for the low reporting rates is that the current platform is incredibly difficult to navigate and does not provide effective helpdesk support.
During an event at the European Parliament organised by Health Action International and TranspariMED, the European Medicines Agency (EMA) announced that it was working to improve compliance and make trial reporting easier.
EMA is now sending out reminder emails to institutions that have failed to post the results of clinical trials within 12 months of trial completion. Starting in April 2019, EMA has been sending around 1,300 such emails per month. It plans to eventually contact all sponsors with overdue trials in this way. EMA reported observing a significant uptick in trial reporting rates as a result of these emails.
In future, EMA is planning to also send out emails 18 months after new trials commence, to remind trial sponsors of their obligation to upload results after the trial has completed.
EMA is developing new guidance materials, such as manuals and videos, for its website.
EMA plans to set up a small focus group of university staff with experience of entering data onto the EudraCT registry to gain a better understanding of the challenges they face in operating the system.
In future, EMA will be more transparent about its efforts to support compliance. It will provide updates on the number of reminders being sent out, the processes for responding to these, and related increases in clinical trial reporting rates.
In addition, EMA reported “working with” its helpdesk to provide better support to trial sponsors struggling to post results. (Trial sponsors frequently describe the current helpdesk as useless.) EMA did not immediately respond to a request by TranspariMED to commit to hiring additional staff to operate a dedicated trial registration and reporting helpdesk.
Source: Slide presented by EMA at the event in Brussels, October 2019
EMA’s announcement comes in the wake of a report by Health Action International and TranspariMED recommending that the regulator should send out email reminders and provide more support to trial sponsors. Subsequent research by TranspariMED and by a Danish team provided more details on the challenges currently faced by clinical trial sponsors.
Till Bruckner, founder of TranspariMED, said:
“The European Medicines Agency’s embrace of active compliance support will benefit patients and taxpayers across Europe by increasing the evidence base on medicines and curbing research waste.
Clinical trial sponsors and transparency advocates alike will welcome EMA’s low-cost, high-impact steps to make it easier to comply with existing rules on clinical trial reporting. TranspariMED will maintain its constructive dialogue with EMA on this topic, and continue to assist the European regulator in identifying barriers to compliance and ways to overcome these.”
Members of the panel also discussed recent legal developments that threaten to put an end to EMA’s proactive release of Clinical Study Reports.
These documents provide detailed data on drug trials not available elsewhere. Panellists representing the European Commission, Cochrane, EMA, Health Action International, Transparency International, and TranspariMED concurred that Clinical Study Reports should remain accessible to the scientific community.
Jaume Vidal, Senior Policy Advisor of Health Action International, said:
“In a moment where Member States are struggling with the full implementation of the EC Clinical Trial Regulation, we are deeply concerned about the possible implications for transparency of clinical trials of the CJEU revisiting its ruling on EMA policy on access to documents. We stand ready to work with partners and allies to avoid a reversal of critical transparency enabling measures.
The session was convened by MEP Michele Rivasi and moderated by Rita Kessler from Prescrire.
Universities that want to improve their clinical trial reporting can find a collection of transparency tools, tips and tricks on the TranspariMED website.