Current situation for clinical trials on medicinal products

Number of Afssaps inspections14

From May 1995 to November 2000, the non-clinical/clinical department of Afssaps has performed 199 inspections, referring to clinical trials on medicinal products.

Afssaps findings

The authorities can bring criminal charges against the responsible person within the company, since fraud and forgery are generally punished by imprisonment and/or fines. Disciplinary procedures may also be initiated against any physicians or pharmacists involved. Among the 160 inspections performed between May 1995 and December 1999, 12 allegations of scientific misconduct or fraud were transmitted to the "Public Prosecutor" of the region where the centre in question was located; 10 involved clinical investigators from the private sector and the two others involved manufacturers. The reasons were:

• Refusal of inspection: 1 case

• Falsification of data, use of false data with or without a "risk to others": 10 cases

• Illegal practice of pharmacy (Livre V of CSP*): 1 case

• Non-compliance with Livre II bis of CSP: 1 case

So far no case has been referred to the Ordre des Médecins.

*CSP: Code de la Santé Publique (Code of Public Health)

Figure 12.2 Number and distribution of clinical inspections (categories and sites) for clinical studies on medicinal products for human use Agence Française de Sécurité Sanitaire des Produits de Santé - Afssaps.

Pharmacies for internal use

Figure 12.2 Number and distribution of clinical inspections (categories and sites) for clinical studies on medicinal products for human use Agence Française de Sécurité Sanitaire des Produits de Santé - Afssaps.

If we compare the Afssaps experience to the international experience, especially that of the US Food and Drug Administration, the types of findings and scientific misconduct are similar.

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