Challenges and Barriers to Adverse Event Reporting in Clinical Trials: A Children’s Oncology Group Report

Miller TP, Marx MZ, Henchen C, DeGroote NP, Jones S, Weiland J, Fisher B, Esbenshade AJ, Aplenc R, Dvorak CC, Fisher BT. Challenges and Barriers to Adverse Event Reporting in Clinical Trials: A Children’s Oncology Group Report. J Patient Saf. 2022 Apr 1;18(3):e672-e679. doi: 10.1097/PTS.0000000000000911. PubMed PMID: 34570002; PubMed Central PMCID: PMC8940729.

Adverse event (AE) reporting is crucial for determining safety of trials. AEs are captured manually by clinical research associates (CRAs) and research nurses (RNs), and prior studies show underreporting. It is necessary to understand AE reporting training, processes, and institution-level differences to improve AE capture. A 26-item questionnaire regarding AE reporting training, identification, tracking, and challenges was distributed to all Children’s Oncology Group (COG) CRAs and RNs from February 15 to March 11, 2019 regardless of if they report AEs based on limitations of COG rosters. Results were tabulated. Institutions were grouped by self-reported full-time equivalents and compared using Chi-square tests.