3 Questions to Dr Dominique Genre
What are the strengths of clinical research at the IPC?
The IPC gathers on the same site all the skills (medical, scientific and technical) that allow the evaluation of new therapies. The Department of Clinical Research and Innovation (DRCI), which has already been present in the hospital for many years, is one of the many resources available to clinicians and scientists to manage innovative projects. Its organization is able to meet the challenges of different types of tests:
- Investigation, with a project manager and a team of technicians and clinical research nurses who ensure the smooth running of the tests.
- Promotion: a manager in charge of the trial coordination with the doctor, from its conception to its completion, and a team of biostatistics and methodology that assists in the test methodology and analysis results until their final publication.
Thus, when the IPC is the promoter of a test, it is a real added value for a future partner to know that the Department will assume the responsibilities of the project whether scientific, regulatory, logistical and operational:
- logistical support necessary for the successful completion of the test,
- assistance in the design of notebooks for observations in the language of the protocol, the data registration and control of its traceability and security,
- the long-term monitoring of patient data,
- the quality of computer data collected,
- expertise in project management: coordinating the collection, verification and possible correction of the data,
- statistical and methodological expertise in designing protocols, notebooks and data formats, in analyzing results and writing of the publication,
- the component "pharmacy" in connection with the manufacturer who supplied the product.
- finally, pharmacovigilance is also provided in-house.
While many clinical studies in the IPC are the result of industrial collaborations, most of them are promoted by academics. The IPC is also promoter of fifteen essays on the current year, representing nearly 10% of clinical studies conducted on the site. These tests are really the heart of research in the IPC in that capacity and mobilize all the teams on campus, including research teams from CRCM.
What is the value of a data processing center labeled by the INCA?
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 mining.
In 2007, INCa (National Institute for Cancer) approved 11 data processing centers, including that of the IPC in collaboration with member of PACA Canceropole.
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 Antione 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.
What are your plans and areas for improvement in process?
The DRCI has been been increasing its quality over a long period. We intend to quickly commit ourselves to an ISO certification as an essential these days vis-à-vis industrial partners.
The medical and paramedical staff is trained in clinical research through training tailored to participants' profiles. We have developed in-house clinical research training for physicians in the IPC and we intend to quickly train 100% of physicians in the IPC and are actively involved in training nurses.
A network of national and international partners
International partners :
- Segal Cancer Centre, Montréal, Canada
- TGEN-TD2, Arizona, Etats-Unis
- Applied Research on Cancer, Vérone, Italie
- Moffitt Cancer Center, Floride, Etats-Unis
- Karolinska Institute, Suède
- Rui Jin Hospital, Shangaï, Chine
Research activity in 2012
- 359 international publications indexed
- 211 clinical trials including 936 patients
- 13 920 samples treated CTCG (Thérapie Cellulaire et Génique) for biomedical research
- 101 920 samples stored at CTCG