WHO WE ARE
The CLUB PHASE I is a French association created in 1993 whose members are individuals involved in the early clinical development stage of medical research and come from a variety of professional areas (Pharmaceutical Industry, Clinical Research Organisations, and Hospital-University).
Denis Gossen, Jean-Louis Pinquer, Philippe Grosjean, Alain Patat, Virginia Parks, Eric Legangneux, Isabelle Paty, Henri Caplain, Yves Donazzolo
Our mission :
To facilitate and develop exchanges on scientific, methodological, regulatory, or ethical topics amongst people engaged professionally in clinical pharmacology studies and to promote early clinical development in France.
ORGANISATION OF MEETINGSThe 6-monthly meetings, usually in Paris, allow the members to get together to discuss a chosen topic. The choice of the topic is usually determined by whether it is current, relevant, and of interest within the profession. These topics include scientific themes (stopping rules, determination of the starting dose…), regulatory (discussion of law proposals, insurance...) or ethical (protection of the participants, volunteer fees…) and are regularly discussed.
The annual congress allows all individuals involved in early clinical development to gather together to participate in plenary sessions or workshops composed of a quality and highly appreciated programme. Close links with other European associations (AGAH in Germany, AHPPI, in the United Kingdom) allow us to extend our discussions during joint meetings (Strasbourg 2005, Hamburg 2007, Lyon, 2009, Berlin 2011).
Our sphere of influence:
Working groups are active all year round and have resulted in well received publications such as:
- The definition of ‘stopping rules’ for healthy subject-first-entry-into man studies, (Sibille et al BJCP, 2010).
- A register of the incidence of serious adverse events in healthy volunteer studies (Patat et al, CPT, 2011).
The association represents activities related to early clinical development to the national Board of Health and other authorities wishing to benefit from our experience.
The association participates in bringing to the attention of politicians and economists, the importance of French expertise in clinical pharmacology and its ability to be a driver for competitiveness.