This Department is devoted to early clinical trials at Gustave Roussy. The Drug Development Department (DITEP) is tasked with offering patients, in whom therapy has failed, access to novel agents and with streamlining the development of new oncological drugs. It has been endorsed by the National Cancer Institute as a Centre for Early Clinical Trials (CLIP²). Since November 2016, the DITEP has obtained the ISO 9001v2015 certification (Quality Management System) for its activities of access to therapeutic innovations, management of early clinical trials, and scientific outreach.
Work at DITEP is led by a multidisciplinary expert committee: medical oncology, immunotherapy, radiotherapy, haematology, imaging, laboratory medicine and pathology.
Organisation of the Department
The Department comprises two hospital units principally devoted to treatment and monitoring of patients participating in early clinical trials:
- An 13-bedded Unit for conventional hospital admissions (conventional SITEP)
- A Day Hospital Unit (ambulatory SITEP) with 16 armchairs
It also depends on:
- An Outpatient Consultation Unit
- An Operational Unit for Early Clinical Trials (SOP²)
Care is provided by a dedicated nursing team which is linked to all the professional input involved in clinical research: medical assistants, medical research assistants, research planners, clinical research associates and managers of blood and tissue sampling. In total, the team collaborating in the research programme counts more than 140 individuals.
A growing number of inclusions in early clinical trials
Thanks to the commitment at Gustave Roussy and to partnerships negotiated with the pharmaceutical industry and with biotechnology companies, DITEP is facilitating a constant growth in the number of patients gaining access to innovatory therapeutic agents.
Patients recruited in our studies (including precision medicine programs) & Patients treated in our early clinical trials since 2010