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Clinical Trials Q4 2023

Breaking down the barriers of academic multinational trials

iStock / Getty Images Plus / Alessandro Biascioli

Jacques Demotes

Director General, ECRIN

Martina Esdaile

Communications Officer, ECRIN

In Europe, almost half of clinical trials are carried out by academics in University Hospitals and other public organisations. While most industry-sponsored trials are multinational, the vast majority of investigator-initiated trials are conducted in a single country.

Even though some academics develop solutions with novel treatments, diagnostics or vaccines, their work often focuses on comparative effectiveness (comparing authorised treatment strategies); treatment optimisation (improving the current treatment regimen or combining treatments); or drug repurposing (exploring new indications for already approved drugs).

Challenges in multinational trials

When developing a trial, the researcher must ensure its feasibility, including access to enough patients and medical expertise to generate high-quality data and statistically robust results. A great way to overcome these issues is to plan a multinational trial, which can come with many other benefits including access to experienced clinical facilities and investigator networks. This is of particular importance for rare diseases but can also benefit large-scale trials in all disease areas.

Initially, the idea of opening the trial to other countries can seem straightforward, but the rarity of this approach in the academic world is challenging. Many barriers exist that can quickly deter even the most experienced researchers: differing national regulatory and ethical approvals, diversity of languages, availability of cross-border funding, contracting with hospital sites, etc.

Many barriers exist that can quickly deter
even the most experienced researchers.

Supporting multinational trials

While European policies and regulations promote enhanced harmonisation and coordination, researchers still need support to bring their ideas to fruition. The European Clinical Research Infrastructure Network (ECRIN) was created to support academic researchers (and small and medium-sized enterprises) planning and conducting multinational trials, in any disease area.

With staff located in all its member countries, it is directly connected to the local clinical trial unit networks and has experience in coordinating these with the entity responsible for the trial.

With expertise in different clinical study modalities, it supports investigators and sponsors in the planning and design phases and then provides coordinated trial management services (at a non-profit rate) during implementation. ECRIN also advocates for the academic clinical research community and develops tools to facilitate working across borders.

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