Regulatory
The study carried out by IQVIA shows that the EEA was home to 22% of commercial trials – those sponsored by a pharmaceutical company – in 2013. By 2023, that had fallen to just 12%. This, in real terms, translates to 60,000 fewer patients accessing a trial involving a country within the EEA, and 20,000 fewer places available in EEA-only trials. At the same time, the number of commercial trials in China has doubled since 2018, and the country now accounts for an 18% share of global commercial clinical trials.
This shifting balance is seen across many therapeutic areas. In oncology, trials in Europe are now below 2018 levels, while the number rose in the US in 2021 and has since plateaued. Some suggest that Europe’s In-vitro Diagnostic Regulation (IVDR), which brings challenges for multi-country trials, is partly to blame.
The number of immunisations, rare disease, paediatric, and cell and gene therapy trials are also falling steadily in Europe. For phase 1 trials, the number has been rising globally for the past ten years, during which time the EEA has seen a decline from 19% to 14%.
ACT EU has established a multi-stakeholder platform (MSP) advisory group to improve the environment for clinical trials across the EU and to promote an open dialogue between stakeholders and regulators. This group, which comprises representatives from key stakeholder groups that are directly impacted by clinical trial-related activities in the EU, meets regularly to provide strategic and operational advice to the ACT EU programme, including on the ACT EU workplan which sets out key deliverables – such as the successful implementation of the Clinical Trials Regulation (CTR).
“The workplan highlights key focus areas, such as innovation in clinical trials, robust methodologies and collaboration across stakeholders,” shares an EMA source. “It is reviewed on a regular basis and revised to better address stakeholder priorities. A new version of the workplan is planned for the end of 2024. Bringing together key players for clinical trials, ACT EU, with its established governance and interaction with the advisory group, ensures that stakeholders’ voices are heard and that regulators collaborate jointly to address priorities.”
Enter the advice pilots
The advice pilot initiative aims to enhance the coordination of advice activities on clinical trials and development programme design within the European Medicines Regulatory Network (EMRN). Specifically, they facilitate closer collaboration
Clinical Trials Insight /
www.worldpharmaceuticals.net
between the Scientific Advice Working Party (SAWP) and the Clinical Trials Coordination Group (CTCG) on advice of a scientific nature, and also make the pre-clinical trial applications (CTA) process, led by the CTCG for advice of regulatory/ administrative nature, simpler. “The goal is to have one single point for applicants for each specific pilot, and to foster mutual exchange between regulators involved in the pilots concerning trial or programme elements, while respecting roles, thus increasing the likelihood of harmonised positions from the different regulatory perspectives,” explains our source at the EMA. “The initiative also helps to minimise avoidable divergences in opinion and improve the EU environment for clinical trials and the optimisation of trial design for the benefit of patients in the EU.”
The first advice pilot offers developers of medicinal products access to scientific advice on clinical trials and on requirements for marketing authorisation applications (MAAs). Typically, assessors of clinical trials are not involved in scientific advice procedures for MAAs, and vice versa. This new pilot sees SAWP (coordinated by the EMA, and the CTCG), which is managed by HMA, assess requests of a scientific nature. SAWP is responsible for advice on MAAs, and member states represented at the CTCG oversee the CTA process. In this pilot, their views are consolidated. This marks the first occasion on which both entities will provide joint scientific advice on clinical trials.
“EU regulators have competency in their respective areas,” notes the EMA spokesperson. “For example, approving CTAs where the trial is
The ACT EU initiative launched advice pilots to improve coordination and harmonise regulatory advice on clinical trials across EU member states.
12% IQVIA 7
The percentage of EEA’s share of clinical trials in 2023.
Stokkete/
Shutterstock.com
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