ACT EU will be running the schemes to help sponsors and biotechs with clinical trial applications and marketing authorisation applications. Image credit: Shutterstock / Panchenko Vladimir.

Two new pilot schemes have been launched to help improve the quality of applications for clinical trials in Europe.

The Accelerating Clinical Trials in the EU (ACT EU) has initiated the pilots to improve how clinical trials are initiated, designed and run.

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The first pilot offers sponsors and biotechs advice on clinical trials and on requirements for marketing authorisation applications (MAA).

As part of the programme, the Scientific Advice Working Party (SAWP), coordinated by the European Medicines Agency (EMA), and the Clinical Trials Coordination Group (CTCG), managed by Heads of Medicines Agencies (HMA), will assess incoming requests.

The SAWP is responsible for advice on marketing authorisation applications and the member states represented at CTCG oversee clinical trial applications.

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This pilot consolidates the views of these two groups to minimise avoidable divergences and is the first time both agencies will provide joint scientific advice on clinical trials.

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The second pilot is coordinated by the CTCG and provides technical and regulatory support on the dossier of a clinical trial application before its submission through the Clinical Trials Information System (CTIS).

Before the pilot, applicants could only receive technical and regulatory support from the member state evaluating the application.

The pilot will provide this advice across a variety of areas, including regulation of low interventional clinical trial status and submission of trials with decentralised elements or complex designs.

Developers who wish to receive advice on the requirements for a marketing authorisation application or a clinical trial application can now apply to these pilots.

Information collected from the pilots will inform a possible change of scope as to how the ACT EU steering group will support clinical trials in the future.

The EMA announced in 2023 that all trials must move from the Clinical Trials Directive (CTD) to the Clinical Trials (CTR).

New applications must all be submitted through the CTR, however, sponsors have until 31 January 2025 to transfer all their ongoing European trials to the CTR. The changes are to be submitted through the CTIS and can take three months to be processed.