EATRIS, the European Infrastructure for Translational Medicine, is pleased to announce its participation in the stakeholders’ advisory group in the ‘COMBINE’ project, an initiative aimed at providing clarity and alignment at the interface between clinical trials of investigational medicinal products, performance studies of in vitro diagnostics, and clinical investigations of medical devices.
COMBINE is an initiative led by the European Medicines Agency (EMA), and EATRIS is proud to contribute its expertise to this project. The IDIBELL Instituto de Investigación Biomédica de Bellvitge, based in Spain and IRCCS Istituto di Ricerche Farmacologiche Mario Negri, based in Milan, will serve as an EATRIS Expert Centres, playing a crucial role as part of the stakeholder reference group of the project.
There is an increasing number of inquiries directed to competent authorities regarding the design and submission of clinical trials involving candidate investigational medicinal products and medical devices/in vitro diagnostics. Competent authorities for medical devices have similarly faced analogous questions. Recognising the urgency of addressing these challenges, several stakeholder organisations have reached out to the European Commission, expressing their concerns about the delays in conducting combined studies in the European Union. These delays primarily stem from the complex regulatory interplay among the Clinical Trials Regulation (CTR), the In Vitro Diagnostics Regulation (IVDR), and the Medical Device Regulation (MDR).
The ‘COMBINE’ project aims to tackle these challenges head-on. The MDR, IVDR, and CTR each contain specific requirements for the respective individual authorisation processes for clinical investigation, performance studies, or clinical trials. While combined studies are essential to ensure that innovative treatments are accessible to patients, the interaction of these procedures has presented a significant challenge. Smoother interplay between these regulations would not only benefit regulatory authorities but also reduce the burden on sponsors and ultimately benefit patients.
In the long-term scope of the project, ‘COMBINE’ seeks to clarify and align the interface between clinical trials of investigational medicinal products, performance studies of in vitro diagnostics, and clinical investigations of medical devices. During the initial analysis phase, the project will focus on understanding the challenges and obstacles hindering the alignment of the three regulatory frameworks (MDR, IVDR, CTR) that intersect in combined studies. ‘COMBINE’ will propose effective solutions to address these issues comprehensively.
Dr. Miguel Angel Souto Mora, IDIBELL Director of the Business Development and Innovation Area, expressed his enthusiasm for participating in this initiative, saying: “The ‘COMBINE’ project represents a vital step forward in enhancing the regulatory landscape. By fostering collaboration and alignment between these critical regulatory frameworks, we can facilitate the development and delivery of innovative treatments to patients more efficiently.”
The ‘COMBINE’ project is set to officially commence on 31 October 2023. Further information about the project, its objectives, and progress updates will be made available on the European Commission website in the near future.
EATRIS is committed to contributing its expertise to this crucial project and working collaboratively to advance the field of translational medicine.
About EATRIS
EATRIS is the European Infrastructure for Translational Medicine. It’s a non-profit organisation that brings together resources and services for research communities to translate scientific discoveries into benefits for patients. Users are given access to a vast array of expertise and facilities from over 150 top-tier academic centres across Europe. EATRIS focuses on improving and optimising preclinical and early clinical development of drugs, vaccines and diagnostics, and overcoming barriers to health innovation. Find out more about EATRIS here: www.eatris.eu
About IDIBELL
The Bellvitge Biomedical Research Institute (IDIBELL) is a research center in biomedicine promoted by the Bellvitge University Hospital and the Viladecans Hospital, both from the Catalan Health Institute, the Catalan Institute of Oncology, University of Barcelona and L’Hospitalet de Llobregat city council. In 2017, the Center for Regenerative Medicine of Barcelona (CMR[B]), now part of IDIBELL, launched the Program for Advancing the Clinical Translation of Regenerative Medicine of Catalonia (P-CMR[C]) together with IDIBELL. IDIBELL research is focused in cancer, neuroscience, translational medicine and regenerative medicine. Research, innovation and society are the axes on which researchers work every day with the goal of improving the quality of life of citizens. IDIBELL is located in L’Hospitalet de Llobregat, south of Barcelona. It is a CERCA Centre from the Catalan Government and a member of the Campus of International Excellence of the University of Barcelona (HUBc). In 2009, it became one of the first five Spanish research centers accredited as a health research institute by the Instituto de Salud Carlos III. In 2015, the European Commission recognized IDIBELL with the ‘HR Excellence in Research’ award, which identifies IDIBELL as a provider and supporter of a stimulating research work environment. Find out more here: https://idibell.cat/
About IRCCS Istituto di Ricerche Farmacologiche “Mario Negri” (IRFMN)
Established in 1961, the Istituto Mario Negri commands recognition as a distinguished research institute dedicated to biomedical and pharmaceutical research. The Mario Negri Institute operates in the field of clinical research since its foundations, and has created a vast network of collaborations, involving clinical center, medical associations, hospitals and universities. This led to important research in the fields of cardiovascular disease, chronic renal diseases, cancer, intensive care and emergency medicine, rare disease, public health, substance abuse and environmental issues. About 260 clinical study are currently registered under the Mario Negri since 2011 (https://registro.marionegri.it/). Through interdisciplinary collaborations, cutting-edge facilities, and a cadre of distinguished researchers, Istituto Mario Negri holds a prominent position in global scientific circles. Its legacy of ground-breaking discoveries and contributions to medical knowledge cements its role as a pivotal force in driving innovative research and healthcare advancements. More here: https://www.marionegri.it/eng/
For further information, please contact:
Dr Jake Fairnie, EATRIS Head of Communications, jakefairnie@eatris.eu
