Europe preps for the launch of its new clinical trials database, with a push to increase trial participation
At the end of this month, the European Medicines Agency will roll out its new, long-awaited Clinical Trials Information System, a one-stop-shop for all clinical trial documentation in the EU that will also support the sponsors and regulators throughout the trials.
Once it’s live, CTIS will offer a single clinical trial application dossier, covering clinical trial applications submitted to EU/EEA member states (and to National Competent Authorities and ethics committees) and registration of the trial, all in one integrated submission.
The launch is the culmination of the adoption of the Clinical Trial Regulation, which entered into force back in 2014. But its application was dependent on the full functionality of CTIS, following an independent audit that was completed last April.
Linda Bowen, global head of regulatory policy and intelligence at Seagen, told Endpoints News that the CTIS is voluntary for the time being and most companies will likely start with one or two submissions in 2022.
“EMA has done a great job in providing training, especially for the master trainers. We will just have to see how it really works. My gut feeling is that sponsors will start slowly,” she said.
CTIS will also offer the general public and researchers a searchable clinical trial database, with results available both as a technical summary and in lay language, according to the EMA.
The launch of the new CTIS, which the EMA clarifies is not meant to replace a clinical trial management system for sponsors, comes as about 40% of trials in Europe are sponsored by academia. Those are often small and only conducted in a single country. The other 60% of trials are sponsored by the pharma industry.
The EMA noted “a recent shift to more academic trials being done during the COVID-19 pandemic,” adding that both academia and pharma sponsors “need greater support and enablement for Europe to flourish as a global focus for clinical research, both in the development of new medicines and in the refinement of use of existing medicines.”
As part of this push for more trials and trial participation in Europe, the regulators this week established a new initiative, known as the Accelerating Clinical Trials in the EU (ACT EU), which lists among its objectives the need to support more large-scale multinational trials “with broader geographical scope,” as well as “reducing administrative burden and increasing efficiency.”
Among its plans, ACT EU wants to develop key performance indicators and a dashboard to track the performance of the European clinical trials environment.
ACT EU, which is run by the EMA, the Heads of Medicines Agencies and the European Commission, also plans to develop and publish key methodologies guidance, including on the impact of AI and machine learning on clinical trials, complex trials, decentralized trials and more, as part of its work to “strengthen links between innovation and scientific advice fora.”
And by leveraging the various academic, non-profit, European and international initiatives around trials, they’re also looking to improve the way research is funded with evidence-based decision making.