DIA Annual Meeting: Most FDA Expert Reviewers See Data Quality Lapses in Applications
A significant percentage of new drug and biologics applications are tripped up by “system-wide” data quality problems, an agency survey of FDA expert reviewers found.
More than two-thirds of the FDA expert reviewers who assess new drug applications (NDAs) and biologics license applications (BLAs) said they encountered data quality problems during the assessments, although only 15 percent led to site inspections or complete response letters, according to the survey.
The survey, unveiled at the Drug Information Association’s global annual meeting, found that the data quality issues frequently led to agency requests for more information.
Half of the survey’s 95 respondents reported issues related to data management and/or programming; 45 percent cited problems with data collection, such as poorly designed case report forms; and 35 percent ran into issues with study conduct, such as protocol adherence and problems with drug accountability and compliance.
“Data quality issues vary, but data management, report structure and study conduct are the most frequent issues,” said Vaishali Popat, an associate director for biomedical informatics in the FDA’s Office of New Drugs (OND).
In the survey, 25 percent reported data traceability issues; 20 percent cited missing safety data; 20 percent found incompatible data outliers, such as males with pregnancy or ages over 150; and 35 percent noted that they saw “other issues” with data quality in their reviews.
The “key takeaway,” Popat said, was that 40 percent ran into “system-wide issues,” such as poor electronic systems and database management and a lack of corrective and preventive action programs.
Additionally, 25 percent of reviewers found data had possibly been misrepresented, while 20 percent found site-related issues, such as no adverse events and perfect efficacy reported at sites with high enrollment.