The ePharma Day is an initiative that aims to provide discussion-events in various European countries concerning issues related to quality compliance as well as to rules, regulation and management of clinical research and drug development with the objective of bringing together people with different perspectives and functions to share common winning strategies and tools that can be applied across the pharmaceutical industry. Myriam Alexandre* and Dr Jonathan Cimino** from CIEC give talk about the achievements and future challenges of clinical research in Luxembourg.
The world of clinical research is in a phase of profound transformation. The acceleration of this scientific knowledge in recent years is leading to an exponential increase in the number of clinical trials with new drugs. It is associated with a profound methodological transformation, which leads to overcoming the classical model of development. To ensure rapid access to patients for new drugs and to contain high development costs, regulatory authorities show a readiness to accept new experimental designs based on eHealth technologies and patient-reported outcome measures (PROMs) using connected medical devices.
In this context, the operators involved in the management of clinical research are facing new important challenges. A few examples: implementation of electronic Informed Consents, protocols based on personalized healthcare, patient involvement, etc. All these changes require a different approach by all stakeholders: pharmaceutical & biotech companies, CROs, Research Centers and Health Authorities.
One of the challenges of the years to come will be the use of new technologies for the benefit of clinical research and patients right & safety: online consent, use and sharing of medical data, identification and development of personalized treatments, connected devices (e-health). The question is: is the Luxembourg ready to cope with the transformation in clinical research?
To meet this daily challenge, the Clinical and Epidemiological Investigation Centre (CIEC) stands for excellence in operational support in clinical research whilst striving to ensure respect of patient rights, data privacy and offering the opportunity to access new, innovative therapeutic approaches otherwise inaccessible. CIEC coordinated more than 140 research projects (academic-private-international) in the last 10 years and gave the opportunity to more than 6800 participants (challenging patient recruitment), some with serious and incurable illnesses, to have access to new treatments in various therapeutic areas such as oncology/hematology, infectious diseases, respiratory diseases, etc. The CIEC evolved to an unique bridge between research and clinic, bringing together researchers and clinicians to answer specific research questions and improve patients healthMore than 25 qualified and engaged clinical research professionals (clinical coordinator, clinical research associates, nurses, data managers and statisticians) are actually part of the CIEC and provide high quality clinical research project management, methodology, statistical services as well as efficient organization of trials with specific expertise in:
*Myriam Alexandre received a Master Degree in Biotechnology in 2004 at the Evry University (France). After that she worked for several pharmaceutical companies in the field of clinical research. Myriam Alexandre joined the Luxembourg Institute of Health in January 2013. As Senior Clinical Research Associate, Myriam Alexandre gained experience in supporting investigators in the conduct of clinical trials developed by pharmaceutical companies or by clinical investigators. Her responsibilities included the management of submissions to ‘Comité National d’Ethique et de Recherche’ and to the Ministry of Health during the start-up phase of the clinical trials, as well as supporting hospitals and sponsors to put in place financial agreements in the regulatory framework. Appointed Clinical Research Manager at LIH in 2015, she now develops and coordinates the activities of a team composed of nurses and Clinical Research Associates to conduct clinical trials and epidemiological studies.** Jonathan Cimino received a PhD in Biomedical and Pharmaceutical Sciences in 2015 at the University of Liège (Belgium). He did a training in cancer research at Harvard Medical School and postdoctoral/project leader position at GIGA-Cancer. After that he worked for several pharmaceutical companies in the field of clinical research as clinical project leader. Dr. Jonathan Cimino joined the Luxembourg Institute of Health (LIH) in November 2017. As Clinical Researcher, Dr. Jonathan Cimino is mainly be responsible for planning development, implementation and coordination of clinical research projects including monitoring activities; contribution to protocol development, CRF design and project plans of clinical research projects with focus on regulatory and organizational aspects. He actively participate in European consortia and grant applications.
Healthcare professionals who wish to be part of a unique network, providing access to up-to-date, accurate and validated information about clinical research.
Investigators and study staff who wish to be part of a unique network, in order to stay abreast of clinical trials taking place in Luxembourg and who are willing to further develop their competencies.