EU foresees reenergized clinical trial sector as new regulations take effect

Regulatory NewsRegulatory News | 27 January 2022 |  By 

Emer Cooke, EMA executive director

The delayed Clinical Trials Regulation (CTR) is set to take effect on Monday, 31 January, marking a milestone in the European Union’s attempt to improve transparency and boost the amount of human research that takes place in the region.
Currently, sponsors must file clinical trial applications to national regulators and ethics committees in each country that they want to include in their studies, then cope with multiple processes for registering their studies and posting results. Officials think the burden of setting up studies has affected the volume of data on EU patients being submitted to the Committee for Medicinal Products for Human Use (CHMP).
“Over the last 10 years, we've seen the proportion of data coming from European patients out of the total decision-making data that comes to the CHMP has declined. Indeed, it's more growth in North America, not just increasing activity in other regions of the world, that is part of that,” Fergus Sweeney, head of the clinical studies and manufacturing taskforce at the European Medicines Agency (EMA), said at a press briefing.
CTR will enable sponsors to apply to run clinical trials in 30 European countries at the same time using the same documentation. Sweeney explained how EMA foresees the single-entry point affecting the thinking of overseas sponsors.
“Historically, [sponsors] might have said, ‘Well, shall we include this member state or that member state or then move to a third one?’ Now, they can think, ‘Okay, let's include Europe, let's go for nine member states or 12, or whatever the number, and it's a single application. This ability to expand to many more member states, to drive the ability to tap into a much wider research infrastructure ... will energize the European research network,” he said.
EU member states will begin using the new Clinical Trials Information System (CTIS) once it goes live. Trial sponsors, however, may use the old process or the new until 31 January 2023. Studies approved under the outgoing Clinical Trials Directive need to transition to CTIS by 31 January 2025.
CTIS was due to go live in 2018 but did not, due to a series of delays, leading EMA to limit its ambition to delivering a minimum viable product to prevent further delays.
“I think it is fair to say that as a network that we underestimated the complexity of the system, what it would take to combine all the existing national approaches and make sure that we could have a coalescence in a single approach that will now serve 30 countries,” said Emer Cooke, EMA executive director.
Sweeney noted that CTIS integrates the clinical trial application and public study registry processes, unlike the US human research trial registry,
“[CTIS is] really this one-stop shop, single application, which fulfills these different objectives, and then the ability to continue the regulatory management of the trial with substantial modifications and other updates, which also inform the public, that are really important in the CTIS system and make it significant and unique globally,” Sweeney said.
The introduction of CTR and CTIS marks a rare diversion from COVID-19 focused activities for Cooke, whose time as executive director has been dominated by the pandemic. Cooke noted that the system supports EMA’s mission in the context of health crises.
“This regulation reinforces the agency's role in crisis preparedness. In the context of future health crises, the agency will be able to facilitate a coordinated EU level response, including the coordination of clinical trials for medicinal products intended to treat, prevent or diagnose disease,” she said.
EMA Notice, Press Briefing


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Tags: clinical, EU, Trials

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