The old adage that prevention is better than cure applies to fraud in clinical research. The cost, inconvenience, and delays incurred by having to redo clinical studies because of lack of confidence in data obtained from a pivotal research project are enormous. Although this chapter will review some of the methods that have been used to detect fraud once it has been committed, the aim of a company should be to prevent fraud being perpetrated against it, not to detect when fraud has been committed. In fact the detection of a fraud perpetrated against a company should be seen as a failure of the company systems, and just as much a criticism of the company as of the person committing the crime.
In a company's attempt to prevent fraud, its attitude and that of its employees is of prime importance. A full and frank discussion covering the company's approach to fraud and its methods used to detect it can act as a major deterrent to an investigator tempted to take short cuts with the study. To achieve this, trial monitors, clinical research associates, medical advisers, and all other people having contact with investigators must have adequate training to make sure that the right message is communicated. A company that gives the impression that a research project is "trivial" cannot expect it to be taken seriously by an investigator.
The application of the guidelines on good clinical practice and good clinical research practice1-3 with the checks and balances they introduce, and the structured approach to the writing of protocol, design of case record forms, and archiving of documentation, have done much to convince investigators that clinical research is a serious issue for the pharmaceutical industry. This change in attitude, and the benefits that come with it, should be one of the main reasons for applying good clinical research practice to all phases of clinical research, not just studies being done for regulatory purposes.
A way to further emphasise the company's insistence on reliable and accurate data is to have a formal contract between the investigator and the company.This is often called "The investigator agreement".This contract, as well as covering finance, timing, etc., should include the following items:
• a statement that the research is to be carried out according to the good clinical practice guidelines (GCP) (If necessary a brief guide to these could be attached to make sure that there was no uncertainty about what this meant);
• a statement that the company reserves the right to audit or do source data verification in order to check the accuracy of the data;
• a statement that it is company policy to pursue all cases of suspected clinical fraud according to a standard operating procedure; if the standard operating procedure is attached, the potential investigator is left in no doubt as to the consequences of fraud.
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