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

TL;DR

This study shows that delays in starting cancer clinical trials are linked to lower success in recruiting patients, especially in early-phase studies.

Contribution

The study provides empirical evidence linking delayed study startup to reduced accrual success in cancer trials.

Findings

Studies with shorter activation times (140.5 days) are more likely to meet 70% accrual goals.

Early-phase studies have significantly longer activation times than late-phase studies (p = 0.001).

Reducing activation time can improve accrual success across all trial phases.

Abstract

Drug development in cancer medicine relies on high-quality clinical trials, and the success of these trials depends on the design, optimization, and execution. Delays often arise from the study startup process, which can take 6 months or more. Complex challenges, including regulatory hurdles, contract negotiations, and inefficiencies in site activation, contribute to these delays. Streamlining these processes is critical to accelerating patients' access to potentially life-saving therapies.

Data from the University of Kansas Cancer Center (KUCC) were used to analyze studies initiated between 2018 and 2022. The accrual percentage was computed based on the number of enrolled participants and the desired accrual goal. Accrual success was determined by comparing the enrollment rate to predefined threshold values (50 %, 70 %, or 90 %).

Studies that achieve or surpass the 70 % accrual 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, indicating shorter median activation times are associated with successful studies. The Wilcoxon rank-sum test (W = 13,607, p = 0.001) indicated that early-phase studies had significantly longer activation times than late-phase studies. We also conducted the study with 50 % and 90 % accrual thresholds; our findings remained consistent.

Longer activation times are associated with lower project success, and early-phase studies tend to be more successful 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.

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