Fraud and Misconduct in Clinical Research: Company Dilemmas and Solutions

It is through intent that fraud differs from error and poor quality. There are different types of fraud: falsification of data, invention of data, or absence or falsification of informed consent. Most often, it is the investigator who commits fraud, or at least fraud is most often committed under his responsibility. The detection of fraud can be easy when there is direct proof, moderately difficult when there is presumed proof, and more difficult with indirect proof. Each company has its own procedures to handle fraud, but nevertheless several points may be highlighted: responsibility should be taken by senior management, compilation of the dossier should be done by the quality assurance department, and an external audit should be systematically carried out. The company should set standards for various degrees of fraud, so that decisions are not made on a study-by-study basis. To set these standards, a committee could be set up following the English (representatives of companies and physicians) or Danish (people with a reputation for honesty and moral behavior) examples to deliberate independently on dossiers submitted. In organizations, fraud is inevitable, but the absence of rules for its management does not favor its reduction. Perhaps by protecting the companies it will be possible to prevent them from being passive accomplices to fraud.