European Union seeks to promote large multi-country academic trials

A newly launched European Union initiative aims to streamline and align clinical trial processes across the continent, and in particular promote large multi-country academic trials.

The document outlining the Accelerating Clinical Trials in the EU initiative acknowledges the substantial research waste caused by underpowered and uncoordinated Covid trials:

“About 40% of clinical trials are sponsored by academia, often small and nearly all mono-national… Recent events including the COVID-19 pandemic has demonstrated a relative absence of EU impactful multi-state trials and analysis of clinical trial applications continues to show registration of a preponderance of small single member state studies. Disharmony of regulatory requirements between Member States complicate the submission of multi-state trial applications.”

Among other things, the initiative will aim at, verbatim:

• Strengthening leadership and coordination on clinical trial authorisation and execution

• Optimising ethical oversight and further integrate ethics committees into the clinical trial and medicines regulatory lifecycle

• Supporting the conduct of large-scale multinational clinical trials with broader geographical scope

• Reducing administrative burden and increasing efficiency

• Heighten the impact of European clinical trials through excellent and coordinated scientific advice as a complement to trial authorisation

• Build capacity in all aspects of drug development and regulatory science through, amongst others, research collaboration and training with academia

Priority actions for the next two years include, verbatim:

• Map existing initiatives and develop a governance rationalisation strategy (aligning different expert groups and working parties in the EMRN and ethics infrastructure).

• [T]he promotion of larger, multinational trials specifically in the academic setting

• Deliver a clinical trials training curriculum including modules on drug development and regulatory science with links to universities and SMEs

IMPACT OF INITIATIVE UNCLEAR

However, it remains questionable whether a lack of pan-European trials was the root cause of rampant Covid research waste, and whether concentrating more power and authority in Brussels is always the best way forward.

Britain's widely praised RECOVERY trial was a single-country trial. Arguably, the main reason why other large European countries failed to generate equally useful evidence was a lack of domestic harmonisation and coordination. For example, a report by Salud por Derecho and TranspariMED showed that institutions across Spain had launched dozens of small unaligned Covid trials that were doomed to futility before they even started.

Furthermore, while the European Union excels at many things, speed and simplicty - key success factors in the RECOVERY trial - are not among them. (Remember Brussels' disastrously slow vaccine procurement?)

On the other hand, particularly in the case of rare diseases - where there are few potential trial participants in any given country - well-designed and well-run international trials really could add substantial value.

TranspariMED and other health groups will keep a close eye on this initiative and work to ensure that it results in better clinical trials that address patient and public health priorities.

TranspariMED strongly welcomes efforts to remove unnecessary red tape and help universities and hospitals to run larger and better trials. However, this should not come at the expense of effective - and efficient - regulatory oversight or patient safety.

Only time will tell whether this initiative will deliver what it promises. Its impact on patients and medical researchers will depend a lot on implementation details that have yet to be hashed out.

The initiative will be co-led by the European Commission, the Heads of [national] Medicines Agencies (HMA) and the EMA, and will be run by a core secretariat.