Department of Investigational Cancer Therapeutics (Phase I Clinical Trials Program), The University of Texas MD Anderson Cancer Center, Houston, Texas, USA;
Oncologist. 2013;18(12):1315-20. doi: 10.1634/theoncologist.2013-0202. Epub 2013 Oct 23.
We conducted this retrospective study to identify reasons that patients referred to a phase I clinical trial failed to enroll or delayed enrollment onto the trial.
Outcome analyses were conducted independently on data collected from electronic medical records of two sets of consecutive patients referred to a phase I clinical trial facility at MD Anderson Cancer Center. Data from the first set of 300 patients were used to determine relevant variables affecting enrollment; data from the second set of 957 patients were then analyzed for these variables.
Results from the two sets of patients were similar. Approximately 55% of patients were enrolled in a phase I trial. Patients referred from within MD Anderson were more likely to be enrolled than patients seen originally outside the institution (p = .006); black patients were more likely than white patients to enroll (69% vs. 43%; p = .04). The median interval from the initial visit to initiation of treatments was 19 days. Major reasons for failure to enroll included failure to return to the clinic (36%), opting for treatment in another clinic (17%), hospice referral (11%), early death (10%), and lack of financial clearance (5%). Treatment was delayed for three weeks or more in 250 patients; in 85 patients (34%), the delay was caused by financial and insurance issues.
Failure to return to the clinic, pursuit of other therapy, and rapid deterioration were the major reasons for failure to enroll; lengthy financial clearance was the most common reason for delayed enrollment onto a phase I trial.
本研究旨在确定患者被推荐参加 I 期临床试验但未能入组或延迟入组的原因。
对来自 MD 安德森癌症中心 I 期临床试验机构的连续两组患者的电子病历中收集的数据进行了回顾性分析。用第一组 300 例患者的数据确定了影响入组的相关变量；然后对第二组 957 例患者的数据进行了这些变量的分析。
两组患者的结果相似。约 55%的患者入组 I 期临床试验。MD 安德森内部转诊患者比医院外部首诊患者更有可能入组（p=0.006）；黑人患者比白人患者更有可能入组（69%比 43%；p=0.04）。从初诊到开始治疗的中位数时间间隔为 19 天。未能入组的主要原因包括未能返回诊所（36%）、选择在另一家诊所接受治疗（17%）、临终关怀转诊（11%）、早期死亡（10%）和缺乏财务批准（5%）。250 例患者的治疗延迟了 3 周或更长时间；在 85 例患者（34%）中，延迟是由于财务和保险问题所致。
未能返回诊所、寻求其他治疗和快速恶化是未能入组的主要原因；漫长的财务审批是导致延迟入组 I 期临床试验的最常见原因。
