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.
Industry Assessment of Risk-Based Quality Management Emphasizes Value of Adoption
April 4th 2024A study conducted by the Tufts CSDD in collaboration with CluePoints and PwC revealed that slightly more than half of sponsors and contract research organizations have adopted risk-based quality management approaches.
The State of the Opioid Epidemic
March 26th 2024In part 1 of this video interview, Greg Sturmer, co-founder and CEO of Elysium Therapeutics discusses the current state of opioid usage including how pain treatment is often mismanaged and how the industry can adopt greater safety standards in developing pain therapies.
