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Clinical research at the Eugène Marquis centre

Clinical research at the Eugène Marquis centre

Clinical research allows patients to access innovative treatments in the safest possible conditions.

Clinical research is carried out by a separate department, comprising a research unit and a promotion unit.It employs doctors, pharmacists, scientists, nurses and clinical research assistants, each with their own special skills.

The research unit selects and carries out all open clinical trials at the Eugène Marquis Centre. It is led by the Therapeutic and Diagnostic Trials Committee (COMEDET) [Comité des Essais Diagnostiques et Thérapeutiques].

The Scientific Steering Committee (CoPilS) [Comité de Pilotage Scientifique] and the promotion unit manage the design and implementation of clinical trials run by doctors at the Centre that are open to patients at the Centre and at other establishments across France.

In 2015, the Eugène Marquis Centre became the Early Phase National Cancer Institute Certified Centre (CLIP²) [Centre Labellisé par l’INCa (Institut National du Cancer) de Phases Précoces] for the region of Brittany, in partnership with Rennes University Teaching Hospital. The aim of the CLIP² programme is to grant patients across Brittany access to innovative clinical trials.

Clinical research management with ISO 9001:2015 certification

The Eugène Marquis Centre has obtained the most recent ISO 9001 certification (2015) for its research activities. This guarantees the quality of all clinical trials carried out at the Centre. It is a quality guarantee for our staff and partners.

Clinical research is a key area of the Centre’s work. Clinical research allows patients to access innovative treatments in the safest possible conditions. This is an important aspect of the Centre’s quality policy.

100.00

The number of trials open to participants, one third of which are led by manufacturers and two thirds by institutions.

450.00

The number of patients included annually in open trials at the Centre, more than two thirds of which are clinical trials. One third of these patients are included in early phase trials (phases I and II).

10.00

The number of studies supported by the Eugène Marquis Centre. Some 50 hospitals participate in clinical trials at the Centre and have referred more than 300 patients over the past four years.

PHASES OF A CLINICAL TRIAL

Clinical research is usually divided into four main phases of development, during each of which numerous studies or “clinical trials” are carried out.

Phase I

First administration to the patient. Determining the posology and tolerance. Interactions between medicines may be studied. In cancerology, these trials involve patients with no other treatment options.

Phase II

Determining the ideal dosage for a specific indication. These studies seek to demonstrate the efficacy of each dosage on a given form of cancer.

LIST OF TRIALS OPEN TO PARTICIPANTS

Phase III

Proving the efficacy and tolerance compared with a standard treatment or placebo. These studies often involve large numbers of patients split randomly between two treatment “arms”.

Phase IV

Pharmacovigilance studies after obtaining marketing authorisation (licence). These studies assess long-term tolerance.

The improvement in recovery among cancer patients over the past 25 years is thanks not only to the work carried out at laboratories, but also clinical research, which is one of the priority objectives of the regional Comprehensive Cancer Centres. The aim of clinical research is to rigorously and objectively compare, in patients, the effect of standard treatments versus new, more promising medicines. All medicines undergo clinical trials before becoming standard treatments.