Abstract B007: Evaluation of deviations reported during monitoring visits in phase 1 oncology clinical trials across the NEXT Oncology site network

Abstract Introduction: Clinical trials in oncology have been increasing rapidly, with 638 registered trials in 2000 jumping to 6571 in 2021 (Izarn). Along with the tenfold increase in clinical trials, there has been an increasing complexity in clinical trial protocols. These complex and multinational studies require monitoring to ensure protocol compliance. Monitoring visits frequently reveal deviations from the protocol, and these deviations are determined to be minor or major. Here, we analyze deviations across our phase 1 oncology network for accuracy and classification. Methods: We evaluated three phase 1 studies at random to determine the average number of assessments per study across screening and cycle 1 for context. Deviations were tracked weekly over 15 months from March 2024 to May 2025 over four sites in the NEXT Oncology network by the compliance team and compiled to find a percentage of the total false and confirmed deviations. Deviations were collected from follow-up letters generated by monitoring visits. These findings were evaluated for accuracy and categorized by type. Categories included major and minor deviations. Deviations were further separated in the months of April and May of 2025 into the number of form errors, pharmacokinetic (PK) flowsheet errors, scheduling errors, and out-of-window or missed assessments. Findings: Across three of our phase 1 studies, the average number of assessments in the screening and cycle 1 period was found to be 395.67 per study. In the 15 months analyzed, 35.01% (1872 of 5347) reported deviations were determined to be false, with 64.99% (3475 of 5347) confirmed. Only 0.98% (34 of 3475) of confirmed deviations were IRB reportable. Of the detailed categories tracked in April and May of 2025, 16.40% (101 of 616) confirmed deviations were from out-of-window PK assessments, 2.60% (16 of 616) were out-of-window vital signs (VS), 3.57% (22 of 616) were out-of-window ECGs, 6.82% (42 of 616) of deviations were missed PK/VS/ECG, form errors accounted for 0.65% (4 of 616) of reported deviations, 1.62% (10 of 616) were PK flowsheet errors, and 0.81% (5 of 616) were scheduling errors. Over the analyzed period, 1235 patients were treated, giving us an approximate average of 2.81 true deviations per patient. Conclusion: Phase 1 studies in oncology are becoming increasingly complex, which leads to a higher risk of protocol deviations. Across our phase 1 sites, it was found that deviations per patient were low in comparison to the number of assessments being collected. By analyzing each deviation, we can continue to work towards even better protocol compliance. We determined that the accuracy of deviations found during monitoring could be improved. Streamlined protocols and monitoring plans may be able to improve resource usage and data integrity in phase 1 trials. Citation Format: Macie Lin, Megan O’Leary, Glenda Chambers, Gabriella Romo, Lisa Cullen, Anthony Tolcher, David Sommerhalder. Evaluation of deviations reported during monitoring visits in phase 1 oncology clinical trials across the NEXT Oncology site network [abstract]. In: Proceedings of the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics; 2025 Oct 22-26; Boston, MA. Philadelphia (PA): AACR; Mol Cancer Ther 2025;24(10 Suppl):Abstract nr B007.