Ther Innov Regul Sci. 2026 Apr 30. doi: 10.1007/s43441-026-00974-4. Online ahead of print.
ABSTRACT
BACKGROUND: The U.S. Food and Drug Administration conducts Good Clinical Practice (GCP) assessments and provides recommendations through Clinical Inspection Summary (CIS) reports to inform marketing application reviews. Despite their integral role in regulatory oversight, the characteristics of GCP assessments and recommendations have not been comprehensively evaluated.
METHODS: This 10-year retrospective descriptive study analyzed CIS reports supporting marketing applications from 2015 to 2024. Data were extracted from FDA internal databases and analyzed. CIS reports were categorized into Tier 1-3, a framework developed by the authors for this study. In Tiers 1 and 2, data were recommended as acceptable to support the marketing application. In Tier 3, specific actions were recommended to address data quality issues.
RESULTS: The analysis included 1,200 CIS reports supporting regulatory review of predominantly New Drug Applications (69.9%) and Biologics License Applications (29.9%), with 68.0% supporting original submissions. The most frequent recommendation tier was Tier 1 (69.5%), followed by Tier 3 (22.5%), and Tier 2 (8.0%). Within Tier 3, most CIS reports contained a single type of recommended action (66.7%), and the most common recommended actions involved requesting additional information (32.8%), conducting additional statistical analyses (28.3%), and incorporating updated data (24.8%).
CONCLUSIONS: GCP oversight largely supported data acceptability for marketing applications, with specific actions recommended to address data quality issues, underscoring its critical role in ensuring reliable clinical data.
PMID:42062756 | DOI:10.1007/s43441-026-00974-4
