PROGRAM LEADERS
Pr Jean-Jacques KILADJIAN is Professor of Clinical Pharmacology at the Université Paris Cité and Consultant Hematologist at Saint-Louis Hospital where he is head of the Clinical Investigation Center (CIC 1427).
His research focuses on myeloid hemopathies, mainly myeloproliferative neoplasms (MPN) and myelodysplastic syndromes. Concerning these diseases, he actively participates in the development of new therapies and develops translational research in the laboratory by developing preclinical cellular (particularly using induced pluripotent stem cells) and animal models. He is author and co-author of more than two hundred scientific articles in international journals and of several chapters of medical books. He is associate editor of the journals: Leukemia, European Journal of Haematology, HemaSphere, Hemato.
Since 2008, he has been elected president of the academic group « France Intergroupe des syndromes Myéloprolifératifs (FIM)”. He is also chairman of the scientific working group on NMPs of the European Hematology Association (EHA), Secretary of the working group on NMP of the European LeukemiaNet (ELN), representative for France of the MPD-Research Consortium (approved by the NIH, USA).
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Dr Zineb GHRIEB, Pharm D:
After more than 10 years of experience in clinical research, on drugs and medical devices in the industrial and institutional sector, and a solid experience as an international manager (in Cardiology, Gastro-enterology, intensive care,…), Zineb GHRIEB, joined the CIC of Saint-Louis Hospital in June 2008 as Project Manager and Quality Assurance Manager. Her additional education (DUs at the Université Paris Cité, in Pharmacologic Oncology, Pharmacovigilance, Toxicology and Immunology) allowed her to quickly become expert in the oncology area, which constitutes 75% of the trials set up within the CIC.
Her qualification on quality management in research (ISO 14155 in Rotterdam and ISO9001_2015, AFNOR in Paris), have consolidated her ethical and effective management of research. She is responsible for Quality management and manages the Clinical Operations team, composed of project managers, CEC, ARC, TRC and interns.
She is also responsible for writing activity reports with the CIC Coordinator and she guides and advises the investigators during the implementation of new projects as well as financial negotiations with the various promoters.
Pr Mathieu RESCHE-RIGON, MD PhD is Professor of Biostatistics and Public Health at Université Paris Cité since 2016, and deputy dean of the Health Faculty since 2019, after having completed his medical learning in the same University, with his MD obtained in 2005.
He hold a PhD in Biostatistics at Research Centre of Economy and Statistics, his main research topic being the multiple imputation method in Cox models for prognosis studies.
He then had a post-doctoral position at MRC Biostatistics Unit, Institute of Public Health · CDDMRC Biostatistics Unit, Institute of Public Health, Cambridge Biomedical Campus, England, United Kingdom.
He is currently the Chair of the Clinical Research Department in Saint-Louis Hospital, where he works in close collaboration with the Early Phase Clinical research Unit.
From his previous experience of ER doctor at Lariboisière University Hospital, he kept a specific interest in the methodology of ICU clinical trials, in parallel with his activities in designing oncology early phase clinical trials, and in the statistical analysis of large database in oncology patients.
He authored or co-authored more than 225 peer-reviewed scientific articles (https://orcid.org/0000-0003-2220-5085)
HEALTHCARE EXECUTIVE
Corinne Marechal
STRENGTHS IN THE FOLLOWING AREAS
Cancer Care
The Cancer Institute includes two Clinical Investigation Centers (CIC): CIC Saint Louis Hospital and CIC Bichat Hospital.
The ARS (Agence Régionale de Santé) “Place of Research Involving the Human Person” (LRIPH) authorization enable us to receive patients included in early phase clinical trials (first administration in humans, phases I and II), which requires a specialized and approved environment. Our CIC has been operating as a week hospital, which is able to receive patients or healthy volunteers 24 hours a day from Monday to Friday, since November 2015.
Patient pathways and experience:
Mastering the patient pathway is a major quality goal for us, which contributes to ensuring the proper conduct of clinical trials.
We have developed patient pathways in order to better inform the volunteers about the typical progress of a clinical trial. It is also intended for health professionals, students and other people interested in clinical investigation. They cover the chronological follow-up of the patient pathway, including the information visit, the official recruitment and the progress until the end of the trial. You will find examples of patient pathways concerning the CIC Saint Louis Hospital by clicking the following link: https://cic-paris-saint-louis.com/parcours-patient/
Patient satisfaction surveys:
CIC-1427 – Saint-Louis Hospital: in order to improve our services and the experience of the patients, we carried out a satisfaction survey in 2018 about the patient’s medical care and the management of the clinical trials by our teams.
Patients included in clinical trials, CIC workers (investigators, clinical research associates-CRA, biological analysis laboratory, etc.) and sponsors (institutional + industry) participated to the survey.
Survey results: https://doi.org/10.1016/j.therap.2020.02.001
This feedback enabled us to establish a plan of action and to determine the improvement priorities in order to meet their expectations.
Quality:
CLIP²
The CIC-P of Saint-Louis Hospital is one of the 16 CLIP² or « Centres Labellisés INCa Phases Précoces » created by the National Cancer Institute (INCa) throughout France since 2010. This accreditation was renewed in 2015 and 2019. Its main objectives are:
- To facilitate the availability of new drugs for patients
- To strengthen the visibility and attractiveness of the French clinical research
- To improve the quality of early phases trials
- To promote academic research by evaluating drugs in rare indications
Certification ISO 9001
Since 2017, the CIC-1427 (Saint Louis Hospital), is committed to the ISO9001_V2015 certification process, by:
- Providing training in quality management for two members of his team at AFNOR (Association Française de Normalisation), with the support of INSERM (Institut National de la Santé et de la Recherche Médicale).
- Developing a quality unit which aimed at:
- Fostering the mindset of continuous improvement of the team
- Moving from a “curative” management mode to a preventive one
- Process monitoring and follow-up through risk management
- Implementing analysis tools:
- Performance dashboards
- SWOT Analysis (Strengths, Weaknesses, Opportunities and Threats) for planning
- FMECA methodology (Failure Modes, Effects and Criticality Analysis), which is used to chart the probability of failure modes against the severity of their consequences.
- Deming cycle (PDCA: plan-do-check-act), for driving Projects forward, with SMART objectives and precise indicators
All these tools have enabled us to continuously improve our processes and organization.
The CIC of Bichat Hospital will soon also obtain the ISO9001 certification. The accreditation process is ongoing.
Research
PHRC, PRTK, PLBIO, PRIME, ANR, CLIIP, AAP ARC, ligue contre le cancer, FRM, GEFLUC, PAIR :
- 5 PHRC (KADIG 01, ACTIW, UCPVax, UCPVax-Cohorte Glioblastome, PICASSO)
- 1 CLIP (METIMGAST)
FHU, SIRIC, RHU, IHU: IHU Thema (Hematology)
Basic science:
- U830 INSERM, Bichat
- UMRS1131 Inserm, Saint-Louis, IRSL
Education
- Pr. JJ. Kiladjian is the coordinator of a first year of Master’s degree named « Preclinical and clinical pharmacology » at Université Paris Cité.
- Dr. Z. Ghrieb is responsible for pharmacy students (in the 5th year, Université Paris IV), as part of their industry research internship (with a dissertation in the end). She is also in charge of trainees during 6 months to validate their CRA (Clinical Research Associates) training (Meddiaxe, Clinact, Université De Vinci, DUFARC, etc.), and of work-study students “Alternants” of the Master 2 “Coordinateurs d’études dans le domaine de la santé”, during a year.
- Pr. X.M. Duval is in charge of a DIU (Diplôme Inter-Universitaire) dedicated to the training of CRAs (Clinical Research Associates) and nurses working in clinical research.
- Pr. G. Zalcman is professor in the national training “INVEST” for clinical research investigators in thoracic oncology (of the IFCT – Intergroupe Francophone de Cancérologie Thoracique) and in the national training “ARTEC” for Clinical Research Associates of Cooperating groups in oncology (GCO – Groupes Coopérateurs en Cancérologie).
- Dr. V. Gounant coordinates the national training “INVEST”. In the context of the Université Paris Cité, she is in charge of the training of the residents (consent process) and general practitioners in clinical research.
- Dr. I. Madelaine is in charge of training oncology pharmacists in clinical research.Find out more about training at CIC 1427 – Saint Louis Hospital: https://www.youtube.com/watch?v=P7SY3iw7sGA