EU Loves Clinical Trials—But Can't Deliver on Regulations

As coronavirus and medicines shortages swirl around Europe, there's no doubt clinical trials command close attention in the European Union's policy framework. Their importance is reflected in the frequent allusions to them in the just-released EU program for health for 2021-2027, designed to "ensure best use of research results and facilitate the uptake, scale-up, and deployment of health innovation in healthcare systems and clinical practice."

The so-called EU4Health program aims to deliver support to clinical trials-not just because of the contribution they can make "to the rapid development of medical countermeasures…in the time of health crisis emergency", but also to address unmet medical needs and speed up "the development, authorization, and access to innovative and effective medicines." The program will, "ensure supply of affordable medicines and reduce shortages across the EU, facilitate clinical trials and ensure safe and effective medicines and vaccines." 

Annexes to the program spell out its ambitions to contribute to "preparedness, prevention and response to cross-border health threats" in the wake of the pandemic. It will, "support and/or procure emergency production of medical countermeasures, including essential chemicals and active substances, and the financing of cooperation on emergency health technology assessments and clinical trials". It will strengthen national health systems with a framework for cooperation among member states and in networks, including those needed to enable member states to deliver joint clinical assessments and joint scientific consultations to exchange outcomes of HTA cooperation." And the criteria for measuring the success of the program will include the, "number of audits conducted to ensure good manufacturing practices and good clinical practices."

Fostering innovation in clinical trials is one of the core goals identified in the European Medicines Agency's recent manifesto, 'Regulatory science to 2025'. It emphasized the need to promote more integrated medicines development, aligning scientific advice, clinical trials approval and Good Clinical Practice oversight. And in a corresponding reorganization of its work, one of the four new task forces created is responsible for "clinical trials and manufacturing strategy".

This early engagement with developers allows EMA to clarify what kind of evidence is required to later evaluate a medicine for authorization on the basis of the then generated data, and thus protects patients from taking part in unnecessary or poorly designed clinical trials.

The agency's just-published annual report pursues the theme, highlighting the wide support shown for innovation in clinical trials during the consultation on its regulatory manifesto, and it proudly recorded, as part of its ongoing work, its new guideline on the investigation of subgroups in confirmatory clinical trials, to assist assessors in European regulatory agencies and clinical trial sponsors.

But in another important aspect of clinical trials, the picture is less bright. The new Clinical Trials Information System, which is necessary for the new Clinical Trials Regulation to come into force (it was initially foreseen for 2018), is still not ready. EMA comments that "this is one of the most complex and ambitious IT developments" it has ever undertaken, since it has to to integrate systems and processes in place in all member states into one virtual workspace that works for all. EMA says it is "on the right track now", after many delays, but the earliest projected date for it to be up and running is now December 2021. The required audit of the system will not now begin until December 2020.