Bone Abstracts

There has been much published about the incidence, detection and prosecution of publication fraud, less about fraud and misconduct in clinical research. We should be equally concerned about research fraud. It is clear that all misconduct is not fraud, and sloppiness would not be so labelled, but the protection of patients must be uppermost of all concerns.

Whichever definition is used, the fact that patients have been exploited remains. This exploitation occurs when Ethics Committee authorisation is not sought or is forged, denying patients the protection of review of the safety and ethics of the study. It occurs when safety data are not recorded or when patients are treated with inappropriate drugs.

Distinction must be drawn between clinical research that is of poor quality and that which is fraudulent. Data with minor errors should be identified by trial monitors from the sponsor company or their subcontractors, and the investigator given the chance to correct it. Such errors are common, represent lack of attention to detail, pressure of work and time, inadequate or over-complicated case record forms, or plain carelessness.

The pharmaceutical industry has been extremely active in its efforts to prevent and detect research fraud and misconduct, and most companies are now comfortable taking action when appropriate. The European Directive on clinical trials, with the International Conference on Harmonisation (ICH) have both aided a growing understanding and awareness of the issue, and most pharmaceutical companies now have standard procedures for handling cases of suspected fraud.

Research fraud is a reality, but physicians and academia have sometimes chosen to turn a blind eye. But the climate now is changing, driven largely by the pharmaceutical industry. Medical research is still vulnerable in the absence of effective mechanisms to combat and detect fraud.