There is “insufficient coordination” within and across member states in multinational trials, report warns
The EU needs to improve the way clinical trials are set up and carried out during public health emergencies, according to a report from the bloc’s medicines regulator.
A range of issues hamper the speed at which clinical trials are set up, including a lack of coordination within and across member states on multinational trials, says the report published on 25 July by the European Medicines Agency.
The report collects insights from a workshop held by the EMA, which was attended by representatives from the agency as well as the European Commission, academic sponsors of clinical trials and national medicines regulators.
“Lessons learnt from the Covid-19 and Mpox public health emergencies of international concern have highlighted the need to improve the way clinical trials are set up and conducted in the EU during crisis times, to ensure that sufficient evidence is rapidly gathered from adequately sized clinical trials across multiple member states,” the report says.
The process of setting up multinational clinical trials is still regarded as “burdensome and slow”, it adds.
The EU introduced the Clinical Trials Regulation in 2022 to harmonise processes for assessing and supervising clinical trials throughout the bloc. But according to the report, the CTR is not working as it should be: varying national requirements remain, it says, which leads to “disharmony”.
The report calls for increased coordination among regulatory bodies involved in implementing the CTR at national level.
It adds that there is a “lack of flexibility” in the CTR that needs to be addressed to avoid bureaucracy and bottlenecks.
The report also recommends that the EU create a committee to improve coordination and make decisions on the prioritisation of clinical trials in Europe.
This coordinating committee would make recommendations on what studies are needed and which clinical trail networks or platforms should be used in an emergency.
The report will be considered by the Commission, EMA and member states as they are working to establish a roadmap for improved clinical trails during public health emergencies.