ETOH, early phase center
To accelerate the evaluation of innovative therapeutic approaches but also to ensure the level of care and quality of the process imposed by this type of trial, the IPC has created ETOH (Evaluation of Therapeutic Onco-Hematology), a unit dedicated exclusively to early clinical trials.
Approved and labeled by the ARS and granted by INCa in 2010, ETOH is the platform of PACA region for evaluating new drugs (in solid tumors and hematology).
Installed on 250 sqm on the 5th floor of the main building (IPC1), the ETOH unit is run by a highly specialized team of 16 people. It has 9 single rooms (5 beds are available on an outpatient basis), a treatment room, monitoring tools and a specific area allowing immediate treatment of blood and urine samples.
In addition to medical expertise of the Institute (surgery, radiotherapy, transplant ...), the team relies on the Therapeutic Intensive Care Unit (specializing in the care of patients with hematologic malignancies) and common technology platforms of the IPC and CRCM: scientific imaging, integrated biology, immunomonitoring, biobank ... administratively, the tests are monitored by the Department of Clinical Research and Innovation (DRCI).
To date ETOH has already led studies of 44 patients (19 in 2010 and 22 in 2011) among which the first administration in man of two drug candidates.
Date of creation: 2010
Staff (IPC and others): 4 MDs (including the 2 directors), 9 collaborating physicians (oncologists, hematologists and 1 radiologist), 1 research nurse, 1 clinical research assistant, 1 technician
DCRI, department of clinical research and innovation
The Department of Clinical Research and Innovation (DCRI) was created in 1998 with purpose of ensuring compliance with Good Clinical Practice (GCP) according to the International Conference for Harmonization (ICH) and to provide enhanced quality of clinical research data.
The DRCI provides regulatory, administrative and educational services to the Institute’s investigators or staff participating in multi center, national and international clinical trials. This resource also serves to increase awareness and accrual to clinical trials as well as to improve the quality and efficiency of conducting clinical trials in compliance with regulatory, documentation, and oversight requirements.
The main goals of the service are: the application of the strategy provided by the IPC Strategic Orientation Committee (Comite d’Orientation Strategique, COS) in clinical research evaluation, the sponsoring of multicenter clinical trials coordinate by IPC’s physicians and providing data management and statistical expertise, registration of databases for specific cancers (breast, prostate, colo-rectum, leukemia, lymphoma…) and graft procedure.
Management & contact: Dr Dominique Genre
Date of creation: 1998 (labelled DRCI in 2011)
Staff (IPC and others): MDs, 1 project manager, 1 pharmacist, 2 administrative assistants, 3 statisticians, 3 data managers, 16 clinical research technicians and 2 clinical research nurses
DMAC, data management and analysis center
The DMAC is the data management and analysis center which provides all or part of the management of clinical trials: computerised logistic assistance so as to guarantee the quality of data collected, i.e. assistance in designing case report forms, data entry and data cleaning, data tracking and security, database lock, data continuity and monitoring of patient data; expert opinion for project management, i.e. ensuring the assignment of the treatment arm by randomisation, co-ordinating data collection, data verification and possible corrections; expert opinion for protocol design, statistical analysis and medical writing.
The DMAC plays a key role in the design and analysis of clinical research projects, data management of each patient involved in testing, storage, sharing and data exploitation.
In 2007, INCa (National Institute for Cancer) approved 11 data processing centers, including that of the IPC in collaboration with member of PACA Canceropôle.
The DMAC comes in reinforcement of existing structures and operational clinical research in oncology within the region (Assitance Publique des Hôpitaux de Marseille and DRCI University-Hospital Center of Nice, Clinical Research Office of the Centre Antoine Lacassagne) and assists them in managing significant data. DPC is a multidisciplinary structure that combines several types of skills: methodologists, statisticians, data managers, clinical research assistants and technicians in clinical research.
The DMAC is National Institute for Cancer (INCa)- and Ligue Nationale contre le cancer (LNCC)- labeled.
Management & contact: Lilian Laborde
Date of creation: 2006 (labelled by INCa in 2007)
Staff (IPC and others): 3 biostatisticians, 3 data managers