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Presse Med. 2007 Sep;36(9 Pt 1):1167-73. Epub 2007 May 22.

[New legislation about clinical research involving "usual care": reminder of recent problems].

[Article in French]

Author information

1
Service de réanimation médicale, Hôpital Henri Mondor, AP-HP, Université Paris-Val-de-Marne, Créteil. francois.lemaire@hmn.ap-hop-paris.fr

Abstract

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.

PMID:
17521859
DOI:
10.1016/j.lpm.2007.02.033
[Indexed for MEDLINE]

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