The role of the Clinical Trials Conduct Unit (CTCU) is to conduct clinical studies in a professional manner, in compliance with European Directives, regulations and Good Clinical Practice – GCP). These clinical studies are carried out in collaboration with pharmaceutical firms and/or academic partners. The Institut Bordet also implements its own clinical studies.
Clinical studies are very closely monitored and must meet the quality criteria essential for ensuring that patients who participate in the studies are protected, while also maintaining a very high level of medical care. Patient well-being is always at the centre of our concerns. The link between the CTCU and the various medical departments is very close. A specific care unit is devoted solely to welcoming patients included in clinical trials: the Novel Treatment Unit.
The clinical studies conducted at the Institut Bordet are coordinated by CTCU research physicians and teams. These doctors are responsible for monitoring patients and collecting data.
Each year, the CTCU welcomes and supervises students as part of their training (nurses, pharmacists, PhD students).
In addition, our researchers supervise young trainee doctors in clinical research on a weekly basis. Also, twice a year, Dr Aftimos gives a course on clinical studies for these young doctors.
Our researchers participate as speakers in the “Midis des Amis” lecture series.
Project 1 (PROJECT FINALIZED BUT NOT YET USED IN PRACTICE ...)
Development of a multimedia support tool for consent to participate in a clinical study
Project 3 (ongoing)
Développement d’un outil informatique assurant l’amélioration du recueil des données cliniques relatives à la recherche (effets secondaires, médicaments concomitants, histoire médicale du patient)
Under the responsibility of the research physician, the clinical research nurses and clinical study coordinators organise and coordinate the different aspects of the clinical studies. They are the point of contact for patients participating in clinical trials and also for all our research partners. They provide personalised support for the patient and are the primary contact throughout treatment.
Explanation of roles:
- The principal researcher is a doctor who manages the execution of the clinical trial on our site. He undertakes to conduct the research in accordance with good clinical practice and in line with the protocol. He appoints his collaborators and determines their role in the study.
- The co-researchers are doctors who include and inform the patients in the trials. They prescribe their treatment, are responsible for monitoring patients, in accordance with the protocol, and for the collection of data.
- The research nurses and clinical study coordinators assist the researchers throughout the trial. Their role is to inform patients, manage appointment planning, administer the treatment (especially in Phase 1), gather information, manage communication between the different parties involved in the study and to implement the technical requirements of the protocol. They are the point of contact for the patient, researchers and those promoting the study.
- The data managers are the encoders who assist the study coordinators and provide information relating to the clinical trials to the promoter of the study (a pharmaceutical firm or academic centre).
- The administrative & start-up coordinator is an administrative assistant who assists the researcher in setting up all new research projects at the Institut Bordet.
- The quality manager implements and manages standardised operating procedures to facilitate the execution of quality clinical trials, in accordance with the rules of good clinical practice. She designs and implements methods and tools available to the CTCU for the maintenance and development of quality.
CTCU Operations Manager
Ana De Veciana
Administrative & start up coordinator
Patricia Ndaya Bilolo
PSOM and Trial Submission CTCU
Study (Nurse) Coordinators :
- For Medical Oncology and Radiotherapy
Nathalie De Naeijer
Rana Ali Osman
- For Anatomo-Pathology (management of biopsies)
- For Haematology
Dominique De Poorter
Lina Adu Poku
- For Radiotherapy
Clémence Al Wardi
- For Thoracic Oncology, Oncological Emergencies and Intensive Care
- For Infectology
- For Nuclear Medicine
Loubna Taraji Schiltz
Le cancer du sein ne disparaîtra pas mais aider la recherche c'est aider à ce qu'il ne tue plus.
Cancer du sein : l'oncologue Martine Piccart à l'honneur
- Foodinaction. 6 Janvier 2016
Des chercheurs belges préparent un traitement révolutionnaire contre le cancer
- 11 Janvier 2017 – Dr Awada (RTL INFO)
Programme PRECISION, commentaires du Dr Philippe Aftimos
- Belgian Oncology - 17/12/14
Economie de la santé : 14% de chimiothérapies inutiles ?
- Le Journal Du Médecin - 16/12/16
Cancer : une thérapie ciblée sur le profil de la tumeur
- Journal en ligne : L'ECHO - 8/5/2015