Whether fraud occurs within the industry itself or at a clinical investigation centre, the types of fraud are the same in France as in other (European) countries. The difficulty of discovery varies, depending upon the possible existence of a whistleblower, the original involvement of the Afssaps, the type of data (modification of a date, clinical parameter or diagnostic procedure, inclusion criteria), and the presence of elements for comparison (for example, sequential events in a single centre, experience of other centres in multicentre studies, etc.). Some frauds involve only a single occurrence (acute fraud), and can be compared at any time with another occurrence preceding the trial. Other cases are more difficult to detect, since they comprise a series of frauds (chronic fraud), each of which may be individually plausible. This type of fraud requires a considerable effort to discover, as does dissimulation or the suppression of data. Discovery of a fraud requires comparison of all available data by comparing documents or a statistical approach.5-6
Source documents are an essential reference. Nevertheless, the information necessary for the detection of fraud is not always available in the trial source documents, and it is frequently necessary to have access to the patient's full medical file or the patient him/herself. In some cases this may lead to conflicts between the obligation for medical secrecy and the requirements of the manufacturer or the public authorities. To avoid this type of conflict, the notion of shared secrecy must be accepted by all parties, and officially integrated into the investigator contract and patient informed consent form. This is now possible in France but unfortunately not always elsewhere in Europe.
Other aspects of the typology - the falsification of data, the concealment of data, and the creation of data are considered elsewhere in this book. Nevertheless, falsifications relating to informed consent must be considered separately.These may involve scientific misconduct (for example, absence of informed consent signed by healthy subjects or patients), or real fraud (for example, creation of false consent forms). Informed consent is a basic premise for the protection of patients and is extensively described in official good clinical practice texts. According to French law on biomedical research, the absence of signed consent forms after the study subjects have been given full information about a study, could lead to legal penalties.
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