[Huriet law: application in a regional cancer centre (Centre Léon-Bérard, Lyon)].
Clinical research is one of the main activities in cancer centres and is submitted in France to a specific law (named "loi Huriet") which includes good clinical practices. We are now conducting a general program of quality evaluation and improvement in the regional cancer centre of Lyon (centre Léon-Bérard). Part of this program is an audit of the application of the Huriet law. Since no instrument exist for measuring this application, we have created a specific one, that attribute notation according to the different aspects of the law. Results show a good level of conformity but sometime non sufficient. There is no difference between the two studied years. Quality changes according to promoters (private or academic) and monitoring. Written procedures and specific training for the different actors are required to improve quality of clinical research with focus on the patient interest.
Chvetzoff
G
G
Département de cancérologie médicale, Centre Léon-Bérard, 28, rue Laennec, 69373 Lyon Cedex 08.
Ray-Coquard
I
I
Dumortier
A
A
Engel
C
C
Mevelec
M F
MF
Latour
J F
JF
Philip
T
T
Chauvin
F
F
D002173:Cancer Care Facilities / Q000592:standards*; D002985:Clinical Protocols; D005378:Financial Support; D005602:France; D006805:Human Experimentation; D006801:Humans; D007258:Informed Consent; D008485:Medical Audit; D015397:Program Evaluation; D011786:Quality Control; D012106:Research