[Good clinical practice in clinical trials: training clinicians,incentives to apply good clinical practice and assessment of compliance].
Fourteen years after the concept was created, it seemed important to assess how well investigators actually apply Good Clinical Practice. Various sources of information have revealed a general deficiency in their application: "investigation by the working group, Afssaps (French Agency for the Safety of Health-Care Products) inspections, industrial data". The deficiencies identified stem from different factors: lack of professionalization, lack of training, lack of motivation, the large numbers of poorly conducted studies. The working group drew up proposals intended to improve the training of investigators, to dissuade investigators from pursuing inadequate procedure and to verify the level of compliance. However in this respect, the investigator is not the only one at fault. Improved practice unavoidably requires better assistance on the part of the sponsors, more consistent supervision of monitoring, and greater vigilence by the authorities involved in the control and use of trials.
Belorgey
C
C
Afssaps, Saint-Denis, France.
Demarez
J P
JP
Jaillon
P
P
D002986:Clinical Trials as Topic / Q000592:standards*; D005602:France; D010601:Pharmacology, Clinical / Q000193:education* / Q000592:standards*; D011786:Quality Control