Investigator Non-Compliance and Fraud

The number of complaints filed with the FDA for investigator non-compliance and fraud rose rapidly in the late 1990s due in part to increased reporting from study monitors, ethical review boards and research sponsors and due to improvements in convenience and anonymity in filing complaints. During the past decade, however, the total number of complaints filed as a percentage of active investigational new drugs (INDs) has been falling from a peak of 6.6% in 2003 to 4.1% in 2011. At this time, the FDA receives an average of 257 complaints for PI non-compliance and fraud each year with protocol violations, data falsification and poor drug accountability the top reasons cited.

Figure 1. The rate of complaints for investigator non-compliance and fraud is falling.

—Tufts Center for the Study of Drug Development, https://csdd.tufts.edu.