title: [Not Available].
abstract: The active patient participation in clinical trials is key for a competitive clinical research. Given this, the Health Industry Physicians and Actors Association (AMIPS) has set up a working group to make communication recommendations towards patients. The group was made of patients, investigators and industry sponsors representatives. Efficacious communication is rarely obtained because it is not clear what is possible to do ethically and regulatory and because of technical and financial constraints. After having identified the expectations and limitations for every actor category, the group has summarized all types of communication, in a sort of tool box, before and during the whole of a study. The benefits and regulatory prerequisites such as the submission to the Ethical Committee and to the National Data Information and Freedom Commission (CNIL) as well as the practical feasibility are described for each tool.
authors.affiliation: Département de Recherche Clinique, Boehringer Ingelheim France, Reims, France; Association des Médecins et Professionnels des Industries de Santé (AMIPS), Paris, France. Electronic address: pascal.bilbault@boehringer-ingelheim.com.
authors.forename: Pascal
authors.initials: P
authors.lastname: Bilbault
authors.affiliation: BESLAY+Avocats, Paris, France.
authors.forename: Nathalie
authors.initials: N
authors.lastname: Beslay
authors.affiliation: Association Française de Lutte Anti-Rhumatismale (AFLAR), Paris, France.
authors.forename: Laurence
authors.initials: L
authors.lastname: Carton
authors.affiliation: Centre National de Gestion des Essais des Produits de Santé (CeNGEPS), Lyon, France.
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Duffet
authors.affiliation: Association des Médecins et Professionnels des Industries de Santé (AMIPS), Paris, France.
authors.forename: Audrey
authors.initials: A
authors.lastname: Gueniche
authors.affiliation: Centre National de Gestion des Essais des Produits de Santé (CeNGEPS), Lyon, France.
authors.forename: Marie
authors.initials: M
authors.lastname: Lang
authors.affiliation: Association des Médecins et Professionnels des Industries de Santé (AMIPS), Paris, France; PFIZER International Operations, Paris, France.
authors.forename: Dominique
authors.initials: D
authors.lastname: Menuet
authors.affiliation: Association des Médecins et Professionnels des Industries de Santé (AMIPS), Paris, France; Société Aixial RC, Levallois-Perret, France.
authors.forename: Hélène
authors.initials: H
authors.lastname: Prunier
authors.affiliation: Association des Médecins et Professionnels des Industries de Santé (AMIPS), Paris, France; Société APROVA, Boulogne-Billancourt, France.
authors.forename: Michel
authors.initials: M
authors.lastname: Levy
keywords: biomedical research; communication en santé; health communication; methods; méthodes; patients; recherche biomédicale; recommandations; recommendations