PIRC (« Pôle Intégré de Recherche Clinique ») coordinates all research activities involving human beings: research on healthy volunteers or patients, research with new vaccine, research using biological samples with or without genetic data, epidemiological studies … Each category of research enters a specific regulatory, legal and ethical framework leading to distinct operational consequences.

In 2009, the PIRC elaborates a research qualification flow chart based on the current legislation. Used by the Clinical Research Committee (CoRC), this new tool allows to harmonize the analysis of the clinical research projects by the CoRC , which evaluates 53 clinical projects (versus 38 in 2008) with a dramatic improvement in the time of response (15 days on average).

In 2009, the PIRC has also implemented two major activities linked to ethical aspects:

1. Institutional Review Board's accreditation (IRB) granted to the CoRC by the Federal Authorities of Health (FDA) of the United States. Its opinion is necessary for American federal funding and for certain publications;

2. Creation of a course (Research on human beings and applied ethics-RPEA) recognized as university degree (DU, Paris Descartes university). Articulated around practical cases and thematic conferences, this course provides an overview of clinical research rules with the objective for the students to integrate the complex and the diverse steps required to succeed in the long process of clinical research. RPEA is an innovative approach as there is at present no other training integrating all the categories of research.

Besides the activities mentioned above, the PIRC is also involved in Drug and Vaccine Development at the Institut Pasteur for both preclinical and clinical phases.

In 2009, the PIRC actively participated into seven projects, among which two major clinical studies involving Institut Pasteur as sponsor:

1. A Gene therapy phase I clinical trial in children suffering of Sanfilippo type B rare disease ( collaboration with Unité des Retrovirus et transfert génétique; Jean Michel Heard) ;

2. A Clinical phase I trial in healthy volunteers of the recombinant HIV clade B Measles vaccine vector (collaboration with Unité de Génomique virale et vaccination; Frédéric Tangy).

To achieve its goals the PIRC has collabored with numerous industrial partners (GSK and Sanofi), foundations (ei. AFM) but also with various competent health authorities, (AFSSAPS (French), AFMPS (Belgium), MHRA (England), EMEA (HAD), FDA (US)).

Keywords: clinical research, sponsor, regulatory requirements, vaccine development, CoRC, Clinical Research Committee