Compliance challenges in clinical research organizations: A USFDA inspection retrospective

Abstract

Context: Clinical research plays a vital role in advancing medical knowledge and improving patient care. As regulatory bodies strive to ensure the integrity and safety of clinical trials, the US Food and Drug Administration (USFDA) conducts inspections to evaluate compliance with established regulations. Aims: To examine the USFDA's inspections and non-compliance actions taken against clinical research organizations (CROs) over a 13 years period. Methods: The study utilizes a comprehensive dataset compiled from publicly available records, including inspection reports, warning letters, and other regulatory documents issued by the USFDA. Through systematic data collection and analysis, this study seeks to shed light on the frequency and nature of non-compliance findings, identify common areas of concern, and evaluate the effectiveness of regulatory actions. Results: The study reveals patterns and trends in the USFDA's inspections, highlighting key compliance challenges faced by CROs. These challenges include issues related to study protocols, informed consent, data integrity, adverse event reporting, and adherence to good clinical practice (GCP) guidelines. Furthermore, this analysis explores the USFDA's warning letters to assess their impact on CROs' compliance efforts. Conclusions: The findings of this retrospective analysis can inform CROs, and other stakeholders about the areas of greatest concern in clinical research compliance. The study contributes to the ongoing efforts to enhance the quality and integrity of clinical trials, ultimately benefiting patient safety and the credibility of the research enterprise.