Regulatory
regulators on regulatory and technical issues allowing potential problems to be identified before the CTA is submitted,” says the EMA. “Different national approaches to specific cases may lead to divergent views among the member states concerned in a CTA. The pilot aims to promote harmonisation of regulatory expectations between different member states, with the aim of achieving greater consistency in the interpretation and application of regulatory requirements, thus simplifying the process for multinational trials.”
Declining trial numbers in Europe highlight the need for innovative solutions to boost competitiveness.
intended to be conducted is under the responsibility of the member state, considering the protection of rights, safety and well-being of the subjects and the generation of robust data. On the other hand, EMA has the responsibility of providing centralised scientific advice based on the evidence to be submitted at marketing authorisation phase, to allow assessment of the benefits and risk of the medicine for the targeted indication during the MAA.”
18% IQVIA 8
The percentage of China’s global share of commercial clinical trials. A figure that’s doubled since 2018.
Regulators could be considering the same trial across different points of view based on their remits, which leads to different views on the same trial. But through this initiative, consolidation and information sharing between regulators, differing views on trial design should be reduced. The second pilot, coordinated by the CTCG, provides technical and regulatory support on the dossier of a CTA before it is submitted to the Clinical Trials Information System (CTIS). Previously, applicants could only receive technical and regulatory support at national level. The new pre-CTA pilot provides the consolidated views of the relevant member states on pre-submission topics. By submitting a pre-CTA advice request, the applicant can ask the concerned member states to express their opinion and provide advice on particular regulatory or technical issues, enabling them to provide useful information to the sponsor, via consolidated responses, and clarify open points prior to submission of the CTA.
The pilot covers several areas, among them advice on regulatory aspects of low interventional clinical trial status, and submission of trials with decentralised elements or complex designs. “The initiative aims to establish an early dialogue between clinical trial sponsors or applicants and
A big step in the right direction Since the advice pilots were officially launched in June, 11 applications had been received at the time of writing – nine pre-CTA and two SAWP/CTCG. So far, the feedback has been positive. “Regarding the pre-CTA pilot, an interim evaluation was carried out at the end of the first five procedures, mainly based on feedback received from sponsors via a survey,” remarks EMA. “Sponsors appreciated the attention paid to advice received on regulatory alignment, as well as the detailed administrative information and guidance received on technical issues related to submission. They also appreciated the simple and fast procedure with replies received in less than a month, but also a relatively simplified dossier, the clear outcome provided in the final letter, and the easy communication with the pre-CTA team.” So far, so good. But there is much more work for ACT EU to do in its efforts to improve the clinical trials process. Its existing workplan includes many clearly defined deliverables to ensure that it achieves its goals, but an updated version is scheduled for publication by the end of 2024, and this will take into account the latest feedback from stakeholders on their priorities towards improving the EU’s clinical trial environment.
The EMA certainly believes that these two new advice pilots represent a significant advancement in the way clinical trials are conducted in Europe, and that by offering comprehensive support and fostering collaboration among key regulatory bodies, ACT EU is revolutionising clinical research and the development of medicines across the continent. ACT EU’s agenda for 2023–2026 includes numerous priority action areas to enhance coordination within the European medicines regulatory network and, ultimately, re-establish the EU as a leading player in clinical research. The pilots seem to provide the kind of robust support that trial sponsors are seeking, and may improve the quality of applications, but the EU still has a long road to travel if it is to catch up with the competition. ●
Clinical Trials Insight /
www.worldpharmaceuticals.net
Andrii Yalanskyi/
Shutterstock.com
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