title: [A case of fraud in a neurological pharmaceutical clinical trial].
abstract: This paper describes the laborious and lengthy path to clarification and disclosure in a case of fraud in a neurological pharmaceutical clinical trial in the Netherlands. A Dutch neurologist was suspected of irregularities within the context of the 'European stroke prevention study 2' (ESPS-2), a multicentre study into medicinal prophylaxis in patients who had suffered a stroke. The Netherlands Society of Neurology (NVN) established an independent inquiry committee for further investigation of the case. The identity of 425 of the 438 patients (97%) included in the trial by the neurologist could be retrieved. The majority of these patients were known to the neurologist with cerebral infarct. For a sample of 115 patients, the general practitioners (GPs) were contacted by means of a questionnaire. Ninety percent of the responding GPs were unaware of their patients' participation in the pharmaceutical clinical trial. A total of forty patients were asked by their GP about participation: 36 (90%; 95%-CI: 76-97) indicated that they had not participated in the trial, and 4 could not remember. The committee concluded that the neurologist had committed fraud, in the sense that he had used the names of existing patients without these patients actually being enrolled in the study. The report of the independent committee was not made public; the committee and the NVN board differed in opinion on the interpretation and implications of the agreements regarding this subject. Following prolonged legal action, the regional Disciplinary Board suspended the neurologist from practice for one year and the court of law sentenced him to 180 days imprisonment or a fee of 130,000 Euro. Based on the experience gained from this case, recommendations in case of suspicion of fraud are discussed, such as the timely appointment of an independent inquiry committee and the establishment of unambiguous agreements regarding the disclosure of the results of the investigation. Possible legal implications should be considered in advance by the organisations involved; statutes should provide regulations for procedural rules. In the Netherlands there now exists a National Body for Scientific Integrity and a committee for the Scientific Integrity of Healthcare Research to prevent scientific misconduct and to stimulate reporting and appropriate handling of this problem.
authors.affiliation: Universiteit Maastricht, ZonMw, Postbus 93.245, 2509 AE Den Haag. hoeksema@zonmw.nl
authors.forename: H L
authors.initials: HL
authors.lastname: Hoeksema
authors.forename: J
authors.initials: J
authors.lastname: Troost
authors.forename: D E
authors.initials: DE
authors.lastname: Grobbee
authors.forename: W M
authors.initials: WM
authors.lastname: Wiersinga
authors.forename: F C B
authors.initials: FC
authors.lastname: van Wijmen
authors.forename: E C
authors.initials: EC
authors.lastname: Klasen
mesh_terms: D002986:Clinical Trials as Topic / Q000941:ethics*; D017041:Ethics Committees; D032984:Ethics, Research; D006801:Humans; D009426:Netherlands; D009462:Neurology / Q000941:ethics*; D015871:Scientific Misconduct / Q000941:ethics*