Greater specialised support for multinational clinical trials
Multi-country clinical trials have significant advantages but the practicalities of setting them up and managing them can be daunting. An EU-funded project involving 23 countries contributed to the ongoing development of an infrastructure that offers hands-on support and boosts Europe's capacity for life-saving research.
© ibreakstock #107901263, 2019 source: stock.adobe.com
The EU-funded project ECRIN-IA accompanied a new stage in the development of the European Clinical Research Infrastructure Network (ECRIN), which strives to create a pan-European research area for clinical studies.
Complementing the core activities carried out by ECRIN, it helped the infrastructure to develop specialised tools and networks that make it easier to launch and coordinate multinational trials focusing on rare diseases, medical devices and nutrition.
Among other activities, the project involved mapping centres with the necessary competencies, updating ECRINs database of regulatory information, and setting out guidance on trial design and methodology in the three focus areas, says ECRIN Director General Jacques Demotes.
In addition, ECRIN-IA which ended in December 2017 funded trials in its three main areas of interest, he reports. Two of these studies were dedicated to rare diseases, an area where the case for multinational trials is particularly compelling. When the disease is rare, the patients are rare and the medical expertise is rare, Demotes says.
Tools, skills, contacts
The project, he notes, was carried out at a particularly crucial stage in the development of the infrastructure: at the time of its launch, in January 2012, ECRIN had yet to be established as a legal entity.
This milestone was reached in November 2013 when ECRIN was awarded the status of European Research Infrastructure Consortium (ERIC). It is now a fully fledged intergovernmental organisation, Demotes points out, adding that this development has also secured ECRINs long-term sustainability.
And the journey continues. As of December 2018, ECRIN has nine member countries and two observer countries, and is involved in an endeavour with an even broader geographical scope: the Clinical Research Initiative for Global Health (CRIGH). Launched in 2016, CRIGH aims in part to encourage international cooperation to rapidly and efficiently respond to global health challenges, such as Ebola and Zika.
ECRIN is now leading a new EU-funded project building up capacity for the management of multinational clinical studies in Europe. Named PedCRIN, this four-year undertaking launched in January 2017 focuses on treatments for children. Paediatric trials are organised, for example, to adapt formulations of medicines originally developed for adults.
PedCRIN, which is dedicated more specifically to non-commercial trials, is taken forward jointly by two European research infrastructures: along with ECRIN, the consortium includes the founding partners of the European Paediatric Clinical Trial Research Infrastructure (EPCT-RI).
A new dimension
ECRIN is striving to unlock the full potential of multinational clinical trials, which have considerable added value, Demotes explains. Among other advantages, they enable researchers to access a much larger patient population and a far wider pool of medical expertise, helping them produce relevant results in a much shorter time frame.
Large clinical trials are also a key asset for the advancement of personalised medicine, Demotes adds. With the advent of high-throughput analytical technologies, they now provide researchers with a wealth of data that can be analysed for stratification purposes, he explains i.e. to identify subgroups of patients who share particular characteristics, typically in terms of which treatment option they are likely to respond to best.
Clinical research is undergoing a digital revolution, Demotes observes. We now have stratified medicine, we have data collected from cohorts or in registries, and we also have data collected by hospitals or healthcare systems in general. In the next few years, this development is likely to fundamentally change the way clinical trials are conducted.
ECRIN, he adds, is dedicating particular attention to this development. Our growing abilities to generate, exchange and process vast amounts of data have opened up exciting possibilities for research, although they also pose challenges. Dealing with the sheer amount of data is not necessarily straightforward, for example, nor are the complexities of preserving patients rights with regard to handling their information, Demotes explains.
We are participating in the European Open Science Cloud project and cooperating with other research infrastructures to tackle the issues it raises, both in terms of the technical aspects and data protection, he concludes.