The EU has initiated two pilot programs aimed at boosting the quality of clinical trial applications amid a broader effort to better integrate clinical research into the European health system.
The two advice pilots were unveiled Monday by the Accelerating Clinical Trials in the EU (ACT EU) initiative — a collaboration between the European Medicines Agency, the European Commission and member states’ Heads of Medicines Agencies.
The first pilot will provide feedback to drugmakers with scientific advice on clinical trials and marketing application requirements, according to an EMA release. The EMA’s Scientific Advice Working Party and the HMA’s Clinical Trials Coordination Group will work together to assess incoming requests, helping synthesize their views and “minimize avoidable divergences.”
The second pilot is overseen by the Clinical Trials Coordination Group and gives “technical and regulatory” advice on clinical trial application dossiers prior to submission. The group will provide “consolidated views” from all member states — in contrast to the state-by-state support drugmakers previously relied on — and cover trials with more complex design elements.
The initiative behind the pilots, ACT EU, was formed in 2022 to support large-scale multinational trials by enhancing efficiency and mitigating administrative burdens. Around the same time, the EMA launched its Clinical Trials Information System, which introduced a single clinical trial application dossier covering trial applications for all EU/EEA member states.
Across the pond, the FDA has also ventured into offering clinical trial guidance, with most recently the launch of a pilot featuring more dialogue between rare disease drugmakers and the agency. In 2018, the FDA also introduced a trio of initiatives comprising a pilot program on complex or innovative trial designs, new draft guidance on first-in-human trials for cancer and advice on when it’s appropriate to use placebo alone in oncology studies.
In 2020, the US agency ended its clinical study report pilot just two years after launch due to limited interest. The program was meant to offer drugmakers more transparency on the approval process, but Janssen was the only sponsor that agreed to take part.