Clinical research on medicinal products

In terms of pharmaceuticals, Europe is said to be divided into two zones: North and South. The North would appear to have a far better reputation and expertise in terms of discovery, development, registration, and manufacture of pharmaceuticals. As in other areas, France finds herself midway between the two as an observer; this is a privileged, intermediate position. Whilst no country is exempt from the risk of fraud in medical research, today it is predominantly the English-speaking and Nordic countries who have established procedures for dealing with this problem. There have been widely publicised cases with appropriate sanctions imposed in Australia, Canada, Nordic countries, the UK, and the USA (open door policy). Even countries such as Japan, traditionally considered to be safe from such abuses for cultural reasons, have recently suffered several scandals involving clinical research.

Management of this problem is difficult in both the individual member states and at the European level, in view of the principle of subsidiarity and despite common pharmaceutical regulations. Each country's code of public health guarantees a high degree of confidentiality of medical files in view of medical secrecy laws.

Any good clinical practice inspection requested by the European Medicines Evaluation Agency must necessarily go through the national agencies (France in this case), with mutual recognition of inspections carried out locally by the national authorities. Today the US Food and Drug Administration inspectors must carry out their own site visits together with a national inspector.

Despite the early and substantial involvement in the internationalisation of drug development, with the exception of Nordic Countries and the UK, none of the European countries has yet undertaken a thorough review of the problem of scientific misconduct during clinical trials of medicinal products.

Most countries maintain a sort of "black list" of persons guilty of fraud during clinical trials on medicinal products, and their identities are known to the responsible persons, mainly health authorities but also the sponsors. The members of Deutche Gesellschaft für Pharmazeutische Medizin (the German Association of Pharmaceutical Medicine),12 consider themselves responsible for the integrity of clinical data and have a black list called "Golden Memory" with the names of involved physicians, dates, person detecting/notifying the case, description of the case, and the outcome of fraudulent activity. Some of the physicians have been forced to return any money involved to the sponsor; some have been sentenced by the courts and forced to leave hospitals, and some have received prison sentences. Personal communication between the authorities (inspectors of Länders*, scientists of the Bundesinstitut fur Arzneimittel und Medizinprodukte or BfArM) has also proved to be effective. France is progressing very rapidly in admitting to cases of fraud. Afssaps has discovered cases of fraud after inspection. Even French newspapers have publicly denounced fraud for the first time.1

The industry and CROs

Good Clinical Practice and Quality Assurance Systems with their "Standard Operating Procedures" (SOPs) improve the quality of clinical trials, allowing adequate monitoring. Audits are carried out by the sponsor and his/her representative is frequently the detector or "whistleblower" of the fraud or misconduct. Most pharmaceutical companies or contract research organisations have a specific standard operating procedure on fraud but suspicions of dishonesty are most frequently covered up for fear of adverse publicity or political problems.

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