Quality Assurance of Clinical Trials and Good Clinical Practices in France

Abstract

Several years ago, US companies with subsidiaries in France initiated the implementation of Good Clinical Practices (GCPs). In late September 1987, the French Medicines Division of the Health Ministry published the “Bonnes Pratiques Cliniques” (BPCs). These official recommendations, the first to be issued in a European country, define the objectives for all parties involved in a clinical trial. The French BPCs are a series of measures that define the responsibilities of sponsors and investigators “to ensure the quality and authenticity of scientific data.” The development of standardized procedures will facilitate the application of BPCs. These guidelines suggest a regular quality verification performed by the sponsor with maintainance of the corresponding reports. This could be confirmed through audits to verify the conduct of studies and also evaluate the authenticity and reliability of the data before submission for registration. Inspectors from the Ministry of Health will control the conformity of BPCs. The application of these guidelines will certainly be reinforced by the December 1988 publication of the French Law on biomedical research.