EMA sets out proposals to reform EU's clinical trials framework

European Commission

The European Commission, EMA and national regulators within the EU have launched an initiative to change the way clinical trials are designed and run in order to position the bloc as an international "focal point" for clinical research.

The broad strokes of the proposals are laid out in a document entitled Accelerating Clinical Trials in the EU (ACT EU) that lists priority actions that will be taken, including measures to allow greater use of innovative clinical trial designs.

One objective is to increase the number of larger, multinational trials – specifically in the academic setting – that can take advantage of the scale afforded by organisations across member states acting together.

The paper notes that the COVID-19 pandemic has exposed that there are relatively few multi-member state trials, with most still being carried out at a national level, as well as "disharmony" between regulatory requirements between EU countries.

The result is slower trial authorisations, and higher costs, which may be the reason why analyses of centralised marketing authorisation applications have revealed a fall in the inclusion of trial results generated within the EU, it suggests.

"The aim is to further develop the EU as a focal point for clinical research, further promote the development of high quality, safe and effective medicines, and to better integrate clinical research in the European health system," according to the EMA.

Top of the list of recommendations is to develop a new governance strategy for studies, drawing on existing initiatives if possible, and to develop key performance indicators and a dashboard that can be used to track the performance of the EU clinical trial environment.

The aim is to bring as many voices into the discussion as possible, including patients, says the document.

There's also a proposal for the EMA and other EU regulators to work on new guidance for innovative trials designs, such as those that use artificial intelligence and machine learning, as well as complex and decentralised designs.

The initiative will build on the EU's 2014 Clinical Trials Regulation (CTR) and the launch of the Clinical Trials Information System (CTIS), which will come into force at the end of this month, having been delayed from its earlier deadline of September 2018.

The CTIS – which is operated by the EMA – will contain the centralised EU portal and database for clinical trials covered by the CTR, is designed to make it easier for trials to be conducted in across EU member states and to increase transparency around studies for the public.

"ACT EU will strengthen the European environment for clinical trials, whilst maintaining the high level of protection of trial participants, data robustness and transparency that EU citizens expect," said the EMA.