Evaluating the impact of delayed study startup on accrual in cancer studies.

ABSTRACT

Background: Drug development in cancer medicine depends on high-quality clinical trials, but these require large investments of time to design, operationalize, and complete; for oncology drugs, this can take 8-10 years. Long timelines are expensive and delay innovative therapies from reaching patients. Delays often arise from study startup, a process that can take 6 months or more. We assessed how study-specific factors affected the study startup duration and the resulting overall success of the study. Method: Data from The University of Kansas Cancer Center (KUCC) were used to analyze studies initiated from 2018 to 2022. Accrual percentage was computed based on the number of enrolled participants and the desired enrollment goal. Accrual success was determined by comparing the percentage of enrollments to predetermined threshold values (50%, 70%, or 90%). Results: Studies that achieve or surpass the 70% activation threshold typically exhibit a median activation time of 140.5 days. In contrast, studies that fall short of the accrual goal tend to have a median activation time of 187 days, demonstrating the shorter median activation times associated with successful studies. Wilcoxon rank-sum test conducted for the study phase (W=13607, p-value=0.001) indicates that late-phase projects took longer to activate compared to early-stage projects. We also conducted the study with 50% and 90% accrual thresholds; our findings remained consistent. Conclusions: Longer activation times are linked to reduced project success, and early-phase studies tend to have higher success than late-phase studies. Therefore, by reducing impediments to the approval process, we can facilitate quicker approvals, increasing the success of studies regardless of phase.