Good clinical practice in clinical trials: training of clinicians, incitation 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: much less than investigation by the working group, Afssaps (French Agency for the Safety of Health-Care Products) inspections, industrial data much greater than. 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 vigilance by the authorities involved in the control and use of trials.