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CLINICAL RESEARCH CENTER - (CRC)
SAINT-LOUIS HOSPITAL, PARIS
CIC 9504 INSERM - APHP
Hôpital Saint-Louis
1, avenue Claude Vellefaux
75010 Paris France
Tel: +33 1 42 49 94 94
Fax: +33 1 42 49 93 97
Department chief : Pr. Fabien CALVO
fabien.calvo@sls.aphp.fr
Associate Professor : Dr. Vincent LEVY
vincent.levy@sls.aphp.fr
The CRC of Saint-Louis hospital and its staff ensure every guarantee of safety, care, support, and courtesy to subjects who agree to participate in biomedical research. We offer the guarantee of ethical conduct as well as of good clinical and laboratory practices.
A DEDICATED SPACE OF RESEARCH
The CRC houses 6 clinical investigation beds, dedicated to outpatient care, a nurse's station, a laboratory room, and administrative offices. This unit is open to investigators from public institutions and to industrial partners who wish to participate in clinical research, dealing with healthy volunteers or ill patients, and on various themes and research domains including:
Drug development (early phase clinical trials), therapeutic strategies, Physiology - Pathophysiology, Genetics, Epidemiology, Dynamic Explorations,...
SPECIALIZED STAFF:
- The Program Director is in charge of the scientific, administrative and financial management, is a specialist in hematology and oncology, and is Professor of Pharmacology at the University of Paris,
- The Vice-Program Director is an haematologist, in charge of the clinical studies and links with the investigators and the associated medical staff,
- A Biostatistician (Research engineer from Inserm) who helps in designing the trials and analyzing data.
- A study nurse and the clinical research assistants provide logistic and technical assistance for projects and the collection of data,
- A nursing team (4 specialized nurses),
- A medical secretary
AN ADVISORY BOARD, WHOSE MISSIONS INCLUDE:
- Feasibility analysis of the projects, Chaired by the Program Director and coordinated by the Vice Program Director, the Advisory Board is composed of clinical experts from the hospital and INSERM staff, pharmacists, biostatisticians and nurses. THE CRC OBJECTIVES - Provide logistical and technical support for designing and carrying out projects to shorten delays for conducting trials. CRC OFFERS - Methodological advices in project planning, CLINICAL TRIALS IN THE CRC OF SAINT-LOUIS HOSPITAL From 2000 to 2005, eighty clinical trials have been conducted in the CRC of Saint-Louis Hospital. In line with the clinical and biological focus of the hospital, they have involved Haematology, Oncology and Immunology (including transplantation, diabetes, autoimmune diseases and dermatology). These include drug development trials, from early phases to strategy options, epidemiological studies, pathophy-siology, cell therapy studies, vaccine development, phenotyping-genotyping studies, pharmacokinetic and pharmacodynamic studies, immune monitoring. HEMATOLOGY-ONCOLOGY TRIALS IN THE CRC OF SAINT-LOUIS HOSPITAL From 2000 to 2005, 38 clinical trials have been conducted in the hematology-oncology field. The hospital departments have records of patients who are ready to participate to clinical trails either in early phases of drug development or in strategy trials (phase III studies). The hospital is well known and is a reference center in Paris area and France for all fields of hematology, chronic and acute leukemia, lymphomas, myeloma, and solid tumors such as cancer melanoma and skin tumors, prostate, breast, lung, colorectal and bladder cancers. EARLY PHASE CLINICAL TRIALS IN THE CRC OF SAINT-LOUIS HOSPITAL The CRC has participated to several early clinical trials on new targeted drugs, especially monoclonal antibodies, tyrosine kinase inhibitors, cell therapy, protease inhibitors... PHASE III CLINICAL TRIALS IN THE CRC OF SAINT-LOUIS HOSPITAL A large number of trials have been conducted in the CRC mainly in the fields of hematology-oncology and immunology. SOME RECENT PUBLICATIONS ARISING FROM STUDIES CONDUCTED AT THE CRC O'quigley J, Zohar S. Experimental designs for phase I and phase I/II dose-finding studies.Br J Cancer. 2006; 94(5):609-13. Thiery G et al.. Outcome of cancer patients considered for intensive care unit admission: a hospital-wide prospective study. J Clin Oncol. 2005;23(19):4406-13. Gabison EE et al. Differential expression of extracellular matrix metalloproteinase inducer (CD147) in normal and ulcerated corneas. Am J Pathol. 2005;166(1):209-19. Tourneur L et al. Absence or low expression of fas-associated protein with death domain in acute myeloid leukemia cells predicts resistance to chemotherapy and poor outcome. Cancer Res. 2004;64(21):8101-8. Zhao WL et al. Vascular endothelial growth factor-A is expressed both on lymphoma cells and endothelial cells in angioimmunoblastic T-cell lymphoma and related to lymphoma progression. Lab Invest. 2004;84(11):1512-9. Peffault de Latour R, et al. Long-term outcome of hepatitis C infection after bone marrow transplantation. Blood. 2004 ;103 (5):1618-24. Terre C et al. Report of 34 patients with clonal chromosomal abnormalities in Philadelphia-negative cells during imatinib treatment of Philadelphia-positive chronic myeloid leukemia. Leukemia. 2004;18(8):1340-6. Larghero J et al. Relationship between elevated levels of the alpha 1 acid glycoprotein in chronic myelogenous leukemia in blast crisis and pharmacological resistance to imatinib (Gleevec) in vitro and in vivo. Biochem Pharmacol. 2003;66(10):1907-13. Sobngwi E et al. Effect of a diabetic environment in utero on predisposition to type 2 diabetes. The Lancet. 2003;361(9372):1861-5. Socie G at al. Late Effects Working Party of the European Study Group for Blood and Marrow Transplantation. Nonmalignant late effects after allogeneic stem cell transplantation. Blood. 2003;101(9):3373-85. Senet P et al. Randomized trial and local biological effect of autologous platelets used as adjuvant therapy for chronic venous leg ulcers.J Vasc Surg. 2003;38(6):1342-8. Gardembas M et al. Results of a prospective phase 2 study combining imatinib mesylate and cytarabine for the treatment of Philadelphia-positive patients with chronic myelogenous leukemia in chronic phase.Blood. 2003;102(13):4298-305. Guilhot F et al. Imatinib in combination with cytarabine for the treatment of Philadelphia-positive chronic myelogenous leukemia chronic-phase patients: rationale and design of phase I/II trials. Semin Hematol. 2003;40(2 Suppl 2):92-7. O'Brien SG et al. IRIS Investigators. Imatinib compared with interferon and low-dose cytarabine for newly diagnosed chronic-phase chronic myeloid leukemia. N Engl J Med. 2003;348(11):994-1004. Molina JM et al. Agence Nationale de Recherches sur le SIDA 090 Study Group. Fumagillin treatment of intestinal microsporidiosis. N Engl J Med. 2002;346(25):1963-9.
- Assistance in project planning and administrative prerequisites,
- Evaluation of methodological and scientific quality of projects and the monitoring of their progress,
- Coordination of scientific activity.
- Development of clinical research within the university-hospital community in partnership with research laboratories, especially those that are part of INSERM and generate medical knowledge,
- Develop clinical research in collaboration with Pharma Companies for innovative new drugs and strategies,
- Train physicians, pharmacists, and paramedical staff for clinical research under good clinical and laboratory practices (GCP and GLP) and provide quality assurance for every task,
- The CRC has repeatedly been audited by INSERM, Hôpitaux de Paris, several Drug Companies and International Institutions which have helped to improve the quality of our work.
- Technical assistance for the regulatory procedures: finding sponsorship, meeting with the ethics committee (CPP), procedures involving the national committee for informatics and privacy (CNIL),
- Recruitment of healthy subjects or patients through its network of collaborations and achieve trials in due times,
- Technical and / or logistic support for carrying out the protocols,
- Aid in data collection and/or analysis Ad hoc aid in financing some projects through scientific programs supported by Inserm and hospitals, aimed in particular at networking.
More than sixty percent of the drug investigations were phase 1 or 2 trials, involving healthy subjects and patients.
Date of publication : mercredi 08 septembre
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