Necker's site clinical research

Clinical investigation centers

Jean-Marc Tréluyer

Clinical investigation center
Professor Jean-Marc Tréluyer

Marina Cavazzana

Biotherapy
Marina Cavazzana

Clinical research organization

Clinical research spans all healthcare research in humans. It is separated from experimental research, which takes place at an earlier stage, but is also closely linked to it in practice. Clinical research is a scientific assessment, which may be prospective or not, interventional or not, with the aim of answering one or more precise and relevant questions. The law distinguishes among three types of clinical research :

  • Biomedical research: interventional research or clinical trial requiring an intervention on the patient, in addition to conventional care (new drug, new medical device, etc.).
  • Intermediate care research: interventional research involving a negligible level of risk and constraints to assess techniques or practices that have already been approved.
  • Non-interventional research: research involving conventional monitoring of patients with data gathering and without any additional constraints.

All these types of research may require the collection and use of biological human samples.

A clinical investigation center

The Paris Centre Necker-Cochin CIC was officially created on January 1st 2009. It is a structure dedicated to clinical research for children and pregnant women and working in close collaboration with the Imagine Foundation in which it takes part.

The mother-child CIC works in close collaboration with the biotherapy CIC, dedicated to gene therapies and directed by Prof. Marina Cavazzana-Calvo, Inserm U943, (Epidemiological research into perinatal health and woman’s health) directed by Prof. Goffinet, as well as the biostatistics services of the Necker (Prof. Landais), Cochin (Prof. Coste) and Hôtel-Dieu (Prof. Ravaud) hospitals.

A methodological research about innovative developmental pharmacology is developed inside the CIC and directed by Dr Saik Urien (Inserm Dr) and Prof. Tréluyer. Studies about ethics in pediatric research are also being developed, directed by Dr Chappuy (PHU).

Structure

The research activity is shared with the Paris Centre Descartes Clinical Research Unit (CRU), structure of the AP-HP Clinical Research Direction.

About 130 people are working within the global structure and 30 are specifically working for the CIC, allowing it to help the investigators at different phases of their projects : since January 1st 2009, the CIC has in Necker-Enfants malades hospital 4 hospitalisation beds, which enable it to welcome patients in the best security and quality conditions possible.

The CIC also has a teaching and training mission. Therefore, the CIC staff takes part in a lot of training activities for clinical research, whether in lectures (medicine and pharmacology schools of the Paris Descartes University), or whether by welcoming students in the structure.

Clinical research supported by Imagine

The majority of genetic diseases are complex conditions that call for both the development of new diagnostic tools and the discovery of new treatment options. To care for children with these diseases, Imagine aims to establish close links between applied and clinical research to accelerate new discoveries.

The Institute's clinical research into genetic diseases concerns the various integrated care pathways included in the IHU's research and healthcare program.

At Imagine, our aim for clinical research is two-fold :

  • Increase the number of innovative therapeutic studies and transform knowledge into effective treatments as rapidly as possible, through drug therapies, biotherapies, cell therapies and gene therapies.
  • Increase the number of patients taking part in these trials.

In order to develop close links between applied research and clinical practice, Imagine decided to provide additional resources and formed a dedicated team. A Clinical Research Manager was recruited in September 2012 to assess needs and set about organizing interaction with the hospital's clinical research structures, the Clinical Research Unit, the Clinical Investigation Center and the Finance and Research Department’s Research and Innovation team. The other addition to the team recruited in September 2012 is a regulatory affairs pharmacist, hired in response to the growing demand for gene and cell therapy trials.

Imagine will back the clinical departments and existing research teams by introducing additional measures at the Necker Hospital campus :

  • Reinforced human resources for the CIC (Clinical Investigation Center), late in 2013 or early in 2014,
  • A team of mobile clinical research nurses, starting in September 2013. The team will be trained to care for patients included in clinical trials in the hospital
  • First clinical research coordinator recruited at the end of 2013 to anchor a sustainable clinical research organization in certain departments and/or reference centers.

Imagine may also develop its own clinical trials during 2014, building on a more closely coordinated promotion structure.

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