Mandatory adoption of the European Clinical Trials System approaches

Concerns about readiness of the European Medicines Agency’s (EMA) Clinical Trials Information System persist as the deadline for compliance arrives.

There will be a mad dash across Europe in the first few weeks of 2023 to complete the operational specifications of the new European clinical trials information system. Although most stakeholders are aware of the approaching deadline (January 31), there are still many adjustments that trial sponsors, national authorities, and the EMA itself must make. 

The system is, of course, intended to simplify the disparate national rules that exist across Europe, but due to the inherent complexity of clinical trials and the process for clinical trial authorization that affects dozens of nations, the new system's implementation will inevitably present its own difficulties. Since the system's voluntary introduction 12 months ago, the EMA has collaborated with sponsors and EU member states to address continuing technological concerns in an effort to ensure the stability of the system and its portal in advance of its adoption by law. 

This experience has helped to identify some of the areas in need of improvement. In the previous few months, some 200 clinical trial applications have been authorised under the new system, and another 200 are being evaluated. It has been a team effort to improve the user experience for the key procedures in readiness of the system becoming mandatory for all new trial applications, as EMA has acknowledged numerous times over the past few months. A number of users have reported issues with the system. The most recent EMA update from December provided features like options for the system to register trial sites not catalogues in a national business registry, to allow multiple users to work on the same application, or a facility for clearly restricting publication of certain documents, for example. 

Despite all the last-minute preparations, in some EU countries concerns about the system's readiness—and that of the intended users in the clinical trials community—have reached a a new peak. Just before the end of 2022, a coalition of German researchers, ethical bodies, and pharmaceutical businesses came together to voice their concern. 

They claimed that after being in use for 10 months, "the CTIS portal suffers from serious shortcomings even after 10 months of use, and for all those involved it is largely unmanageable," and that the issues worsened rather than improved. They cautioned that applications for clinical trials and those being processed by ethics committees "are massively impaired and cannot be managed." They continued, adding that "If this portal does not function properly, the entire system of the EU regulation is in danger of failing," which may gravely harm patients as well as Europe's competitiveness as a site for research. The already-worrying shift to conduct clinical trials outside of Europe may increase. What they term “the dysfunctional nature of the portal” is such a concern that the deadline should be extended.

The likelihood of any such delay occurring seems slim. The German delegation at the EU health council in late December formally brought up the issue at the German coalition's insistence, but the council only noted the opinion. In a just a few days, the system—perfect or not—will become operational, and it seems that the clinical trial community will just need to adapt and adopt accordingly. It should be noted that the EMA have provided an extensive series of training resources and you can also gain insights from EUFEMEDs recent series of Webinars on the CTIS.