EU regulators set targets to promote European clinical trials

Editor’s Note: This article has been updated to correct the estimated number of trials EU regulators wish to add in the next five years.

EU regulators announced on Tuesday that they want to substantially increase the economic zone's attractiveness to companies conducting clinical trials to increase the number of multinational trials in Europe by 10% over the next five years.

In a joint statement, the European Commission (EC), the Heads of Medicines Agencies (HMA), and the European Medicines Agency (EMA) announced they have set two ambitious targets to boost clinical trial activity in Europe. They are ultimately intended to encourage more medical reaching European citizens.

The regulators' first objective is to increase the current annual number of multinational clinical trials authorized in the EU from an average of 900 to 1,000 by the end of the five-year period. The regulators estimate they will be able to add about 100 trials to the average each year.

The regulators also want to improve how quickly clinical trial participants are recruited. They noted that, currently, about 50% of trial participants are recruited within the first 200 days of the trial application submission. However, they want to increase incentives so that two-thirds of participants are recruited within that timeframe.

"These ambitious goals build on ongoing efforts to create a more supportive environment for clinical research," said the regulators. "A key part of this is the Accelerating Clinical Trials in the EU (ACT EU) initiative, a collaboration between EC, HMA and EMA, which seeks to optimize how clinical trials are designed and run."

The regulatory bodies launched ACT EU in 2022 with the aim of creating a more favorable clinical trial environment. It uses recommendations from the European medicines agencies network strategy and the European Commission’s Pharmaceutical strategy for Europe to propose regulatory changes that encourage clinical trial research.

The regulators listed several initiatives from ACT EU, including developing a clinical trial map to help patients find trials in their area that they may qualify for, advising sponsors through pilot programs to help them design better clinical trials, implement the revised Good Clinical Practice guideline (ICH E6 R3); and help non-commercial sponsors conduct more multinational trials. They also noted that there are several complementary network initiatives that will help them achieve their goals, including the Clinical Trials Regulation (CTR) Collaborate initiative, the COMBINE program, and MedEthicsEU.

Alongside the announcement, the regulators also released a report on the state of clinical trials in Europe between 2022 and 2025 when the EU transitioned to the EU Clinical Trials Regulation (CTR). The report notes that by January 2023, it became mandatory for sponsors of all clinical trials to transition to the Clinical Trials Information System (CTIS). It states that by January 2025 5,088 clinical trials had migrated from EudraCT under the Clinical Trials Directive (CTD) to CTIS.

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EU regulators set targets to promote European clinical trials

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