[Not Available].

Therapie

Association des Médecins et Professionnels des Industries de Santé (AMIPS), Paris, France; Société APROVA, Boulogne-Billancourt, France.

Published: July 2016

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.

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Source
http://dx.doi.org/10.2515/therapie/2014219DOI Listing

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