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News|Articles|September 1, 2013

Applied Clinical Trials

  • Applied Clinical Trials-09-01-2013
  • Volume 22
  • Issue 9

Investigator Non-Compliance and Fraud

Tufts CSDD

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.

Articles in this issue

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Electronic Data Capture in Clinical Trials

almost 13 years ago

Japan Relaxes Clinical Trial Regulations; China Still Strict

almost 13 years ago

The Shift to a Centralized Lab Approach

almost 13 years ago

Business and People September 2013

almost 13 years ago

ACT Insert Cover

almost 13 years ago

Translational Medicine and Biomarkers

almost 13 years ago

FDA, Research Organizations Seek to Bolster Drug Submissions

almost 13 years ago

Suicidal Ideation and Behavior: We Can Make a Difference

almost 13 years ago

ACT Cover

almost 13 years ago

Streamline and Improve Study Start-Up

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