Universities and university hospitals offer guarantees to external partners in terms of techniques, knowledge and expertise Interview with Mrs Dominique VAN OPHEM, Administrative Director of the Clinical Trial Center (Cliniques Universitaires Saint-Luc)
monitoring and closure of studies (performance indicators). The CTC also promotes quality assurance of clinical research projects, including AAHRPP accreditation (Association for the Accreditation of Human Research Protection Programs), harmonisation of training, setting up of an internal audit unit and the implementation and monitoring of quality procedures within the institution. Internally, the CTC has close links with the biobank of the CUSLs, whose objectives are to make human body material from the CUSLs available to internal and external researchers in compliance with the rules issued by the ethics committee and the legislation in force.
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© CTC - CUSLs
hat are the key figures for the Clinical Trial Center (CTC) and clinical research at Cliniques Universitaires Saint-Luc (CUSLs)? In 2019, via the CTC, the CUSLs carried out 568 study submissions to the Saint-Luc UCLouvain Hospital-Faculty Ethics Committee, 35% of which concern academic research. 654 prospective studies (51% academic and 49% commercial) are underway, 51% of which are medicinal. Drug trials carried out at the CUSL represent 28% of the clinical trials registered annually at the FAMHP (Federal Agency for Medicines and Health Products). The drug trials carried out at the CUSLs cover phases 1 to 4. In 2019, 1035 patients were recruited in commercial studies. In addition, clinical research employs 100 FTEs and the CUSLs work in collaboration with UCLouvain by supporting translational research “from bench to bedside”.
Could you give us some examples of clinical studies in progress in relation to the pharmaceutical industry? In adult and paediatric onco-haematology, the CUSLs frequently conducts early phase (phase 1- first in man) studies on all solid and haematopoietic tumours. In neurology, its studies focus on strokes, Parkinson's and Alzheimer's diseases as well as multiple sclerosis. The CUSLs is also active in adult and paediatric hepatogastroenterology with a focus on liver disease and Crohn's disease. It is also interested in rheumatology (lupus, polyarthritis), cardiology (rhythm disorders, high blood pressure, heart failure), dermatology (dermatitis, psoriasis), pneumology (asthma, fibrosis, apnea) but also infectious pathologies (HIV, bacterial and viral infections).
© CTC - CUSLs
Could you tell us about the CTC’s mission? The mission of the CTC, composed of 12.3 FTEs, is to professionalise clinical research in the institution and to cover all aspects relating to commercial and academic research both economically and organisationally. The CTC ensures the implementation and monitoring of all clinical research projects, from the preparation of technical-regulatory dossiers, the supervision and approval of contracts, the issuing of project start-up authorisations to the
The building of the Cliniques Universitaires Saint-Luc
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What do you see as the next challenges for post-COVID-19 clinical research? I see two main ones. The first is the integration of intensive digitalisation of clinical research in compliance with the legislation in force. This concerns contacts with the pharmaceutical industry (remote monitoring, electronic signature of contracts, Investigator Site File type electronic files, artificial intelligence, etc.) and with patients (electronic consent, data collection via applications or electronic devices, remote visits) with a triple challenge: ensuring respect for privacy, enabling the development of research without dehumanising the patient/doctor relationship and respecting the respective roles of industry and research centres. The second challenge is to maintain the attractiveness of Belgian clinical research centres by continuing to highlight the quality of the research carried out in our hospitals and the expertise of our researchers. This implies speeding up the start-up of trials by standardising practices with the support of the authorities and the pharmaceutical industry. Ultimately, the future relies on close links between universities and university hospitals that offer guarantees to external partners in terms of techniques, knowledge and expertise.
