Prevention Of Clinical Trial Fraud In Europe

The problem of fraud and scientific misconduct in clinical studies,although in decline since the introduction of Good Clinical Practice standards, is still a pressing one, according to Joachim Schwarz of Quintiles GmbH in an article entitled "Detection, Handling and Prevention of Fraud in Clinical Studies in Europe," published in Drugs made in Germany (40, no 1 1997). In his paper, Dr Schwarz focuses on fraud by investigators, and stresses that the need for "a coherent harmonized European policy" to combat this problem "is obvious."

According to the US Food and Drug Administration, which published a guide to the detection of fraud in 1993, "fraud may be defined as the deliberate reporting of false or misleading data, or the witholding of reportable data." Fraud may be differentiated into three types, the FDA adds, those being: - altering data, eg changing animal weights or breaking the study blind/randomization; - omitting data which may be important to the outcome of the study, eg not reporting adverse events; and - fabricating data, eg duplicating results generated from one patient to represent another.

Dr Schwarz points out that these questionable practices may occur for a variety of reasons, for example, pressure from the sponsor or commercial interests. He adds that fraudulent activity is facilitated by the "lack of countermeasures from sponsors and responsible authorities, despite their knowledge of such activities."