Fraud in clinical trials

Buyse M, George SL, Evans S,etal. The role of biostatistics in the prevention, detection and treatment of fraud in clinical trials. StatMed 1999 18 3435-51. 

Law, J (1999), Lighting fraud in clinical trials. Scrip Magazine, September 1999,... 

Research is also strongly influenced by the admittedly legitimate interests of the pharmaceutical industry examples of this include contract clauses reserving copyright, the initial selection of researchers and topics, and the recent consolidation of the position of companies specializing in clinical trials (to the detriment of academic centres). Frequently there is a conflict of interests between social welfare and private welfare that does not necessarily amount to fraud or malpractice, but which should be made public - through... 

Misconduct or fraud is a rare occurrence in clinical research, but when misconduct or fraud is confirmed the consequences can be disastrous (Lock et al., 2001 Eichenwald and Kolata, 2004). Fraudulent practices in clinical trials can lead to trial subjects being exposed to safety risks, to submitted or published clinical data being j eopardized and, if the product has been licensed based on false data, this may result in compromised patient safety. Therefore, any suspected case of misconduct or fraud should be taken seriously and be assessed -this is when QA auditors should be involved. 

The FDA plays a major part in the prevention and detection of research fraud and misconduct. The FDA carries out two different types of reviews. Study-orientated audits are conducted on clinical trial data itself, in order to ensure patient eligibility, and investigator-orientated inspections can be carried out either routinely or because a sponsor has concerns. If the inspectors have reason to believe that a site has not complied with regulatory requirements or has engaged in fraudulent activity - for which the definition in the Federal Code is very similar to that of the Wellcome Trust - they have the power to disqualify the investigator from taking part in further research, or severely restrict his activities. Such findings are widely publicized both within and outside the United States on the so-called Black List . 

Two further cases will never be fully documented, because they involved doctors who died prematurely, one where the coroner recorded that the death was due to suicide, the other where the coroner reached an open verdict. In both cases the fraud discovered was multiple, and on a very extensive scale, where the doctor involved had gone to very great lengths to disguise the nature of his fraudulent activities and had thus hoodwinked clinical trial monitors and auditors, who had not detected anything amiss. Original patient records... 

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