Objective: The regulatory framework of clinical research in France was recently modified substantially, in part to transpose into French law directive 2001/20/EC of the European Parliament and Council, which concerns only drug trials. The revision also covered research on "human beings" (Public Health L. 2004-806, 2006-450), on biological samples (revision of bioethics, L. 2004-800) and on data (the so-called CNIL act, L. 2004-801). The value of this set of texts (statutes, decrees, and regulations) is that it diversifies and clarifies the different forms of clinical research.
Methods: This article describes the painful progression of important public health studies, most often with "academic" sponsors.
Results: The 5 studies described here managed to overcome a variety of obstacles posed by the pre-2004 regulations.
Comments: To understand the new provisions, it is useful to recall the difficulties, imprecision and inaptness of the earlier regulations.