Scientific Misconduct in Investigations Drug Trials

Abstract

As part of its effort to ensure the safety and efficacy of the pharmaceutical products that it certifies, the Food and Drug Administration systematically audits investigators and takes action against those who have engaged in scientific misconduct. The investigators who are audited are those conducting clinical trials of investigational new drugs, usually under the sponsorship of pharmaceutical companies. We examined data from the FDA monitoring process to determine the extent and nature of identifie misconduct in this kind of clinical research.In this study, scientific misconduct is operationally defined as (1) the execution of a study in a way that . . .