Data Integrity Lapses in Clinical Studies Prompt Approval Delays

The data integrity issues most likely to lead to a delay in FDA marketing approval for new drugs include poor quality control for data entry, systemic errors at clinical study sites — such as enrolling ineligible patients — and database changes made after an initial database lock and study unblinding.

These are some of the key takeaways from a deep dive into the FDA’s own data on clinical trial inspections, said Beverly Lorell, senior medical and policy advisor for law firm King and Spalding’s FDA and Life Sciences Practice Group.

Lorell points to two important documents — the first is the FDA’s annually updated Bioresearch Monitoring (BIMO) Program Metrics, which provides details about each year’s inspections of sponsors, investigators and independent review boards; the second is a one-time study conducted by officials in the FDA’s Office of Scientific Investigations (OSI), which delved into a single year of agency actions around those BIMO inspections.