Clinical research fraud

The system for dealing with doctors suspected of research crime in the United Kingdom revolves around the GMC, which stated in 1992 that their disciplinary committee would take a very serious view of proven clinical research fraud. Since 1990, 26 doctors accused of research fraud have been reported to the GMC, all but 1 being found guilty. The penalties imposed ranged from erasure from the Medical Register, to admonishment and limitation of future research. The GMC can only investigate suspected fraud or misconduct after a formal... 

Three elements are necessary to improve the situation. There must be official bodies in each country with real powers to investigate and prosecute clinical research fraud. There must be a widespread and unequivocal acceptance that failure to act on suspicions of fraud is itself serious misconduct. And finally there must be an... 

Most clinical researchers, like most members of the public, are honest. However, to pretend that clinical research fraud and misconduct do not exist is to allow bad medicine, bad science and, above all, abuse of patients. 

As soon as fraud is suspected, a series of steps needs to be followed which have been thought out and written down as an SOP before any clinical research commenced. Where possible, additional evidence should be obtained, usually by the use of a competent QA auditor. In the meantime, only the minimum key individuals should be made aware of the problem until sufficient evidence has been obtained to establish the truth. The appropriate authorities such as the national drug industry organisation and the regulatory authorities should be informed if fraud has taken place. Sometimes, other sponsors will have reported additional evidence that fraud is taking place at a particular site. The site will need to be closed if study subjects are still being recruited and a full explanation provided to the authorities. Any clinical data collected will need to be reviewed and a decision made as to whether any of the data can be included in an analysis. To a pharmaceutical physician, fraud is never an easy situation. It usually involves a professional colleague and there is always the worry that the established facts have been misinterpreted. However, a fraudulent individual cannot be tolerated in modern clinical research. 

The introduction of GCP has accelerated the need for quality control and quality assurance, particularly in the field of clinical research. Quality control is carried out by the staff who are responsible for the particular activity, working to SOPs that cover all the tasks under scrutiny. SOPs not only need to be written but must also be updated regularly. Quality assurance is the process which seeks to confirm that SOPs have been observed this is accomplished by the process of auditing. Internal audit departments should be under a separate management from the medical department. Regular audits can not only assure external bodies, such as regulatory authorities, that proper procedures have been followed, but also serve to deter those rare attempts at fraud on the part of clinical investigators, which occasionally become evident. ... 

Fraud and Misconduct in Clinical Research, Royal College of Physicians of London, 1991. 

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. 

There has been much published on the incidence, detection and prosecution of publication fraud, rather less on fraud and misconduct in clinical research, but we should be equally concerned about research fraud. The Consensus Conference on Misconduct in Biomedical Research convened by the Faculty of Pharmaceutical Medicine and the Royal College of Physicians of Edinburgh in 1999 defined research misconduct as behavior by a researcher, intentional or not, that falls short of good ethical and scientific standards . Frank Wells, co-founder of MedicoLegal Investigations Ltd., the only specialist research fraud investigation company in Europe, prefers the generation of false data with the intention to deceive . 

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 . 

Ankier S. 2004. Misconduct and fraud in clinical research. In Medical Law and Research. Ankier Associates. 

Every person involved in clinical research, be he/ she a monitor, an auditor, a statistician, a medical adviser, a medical director, a head of department, a co-investigator, a company or health service chief executive, or a university vice-chancellor, should be committed to such a policy and to its publicity, not least to act as a deterrent, in a determination to stamp out fraud in clinical research if it is humanly possible. Every international company, every regulatory authority, and every individual pharmaceutical physician should strive to ensure that there is an effective mechanism in place, in every country, by which anyone who commits fraud can be summarily dealt with. Only the utmost vigor in applying this policy will be successful, but it is in the ultimate interests of patient safety that this happens. 

Wells F (1994) Fraud and misconduct in clinical research. In Griffin J, O Grady J, Wells F (eds). The Textbook of Pharmaceutical Medicine Queens University Belfast. 

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... 

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