The role of data audits in detecting scientific misconduct. Results of the FDA program.

Overview

To evaluate the extent of the problem of scientific misconduct in investigational drug trials, we reviewed data from 1955 routine audits conducted by the US Food and Drug Administration (FDA) from June 1977 to April 1988. Serious deficiencies were detected in 12% of audits prior to October 1985, but in only 7% since that date. At the same time, there was no evidence of a decline over time in the rate of detection of many categories of deficiencies, and some investigators were able to continue to participate in drug trials after flagrant violations of recognized norms of research. The data auditing program should be continued, but additional measures are needed to regulate misconduct. These must be tailored to the variety of causes of misconduct, ranging from negligence to fraud. Possible additional approaches could include certifying the competence of potential investigators; peer-reviewed, competitive application for the opportunity to conduct FDA-authorized clinical trials; limiting an investigator's level of participation in clinical trials; penalizing manufacturers who fail to detect their investigators' misconduct; and permitting the FDA to suspend investigators prior to a hearing. Measures taken should maximize public utility at the least economic cost to society and should be evaluated thoroughly.