了解泌尿癌临床试验的终止:见解和挑战
Abdulrahman Alhajahjeh1,2,3, Majedah Hmeidan4, Mus'ab Elatrsh4
1Center for Anesthesia Research Excellence (CARE), Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA.
JCO global oncology
|January 11, 2024
概括
泌尿癌临床试验的终止率为25%,主要是由于患者积累率低. 大学资助,单中心研究和小样本规模 (<50) 预测提前终止.
科学领域:
- 在瘤学瘤学.
- 临床研究 临床研究
- 泌尿系统恶性瘤
背景情况:
- 临床试验对于推进癌症管理至关重要.
- 试验的提前终止浪费资源,并影响患者的护理.
- 了解导致试验中止的因素至关重要.
研究的目的:
- 确定泌尿癌临床试验的终止率.
- 确定与这些试验提前终止相关的因素.
主要方法:
- 来自ClinicalTrials.gov (2000-2020) 的完成和终止的泌尿癌试验 (脏,前列腺,膀) 的横截面分析.
- 评估终止试验的原因.
- 多变量分析以确定终止的重大预测因素.
主要成果:
- 9,145个瘤学试验中有11.30%是泌尿癌试验 (n=1,033).
- 25.38%的泌尿学试验 (n=265) 被终止,在52.9%的病例中引用了低患者积累率.
- 大学资助 (OR 2.20),单中心研究 (OR 2.11),和小样本大小<50 (OR 5.26) 显著预测终止 (P<.001).
结论:
- 泌尿癌临床试验的终止率为25%,最常见的原因是患者招募不足.
- 大学资助,单中心和小规模试验 (<50名参与者) 的早期终止风险更高.
- 识别这些风险因素可以引导更好的资源配置,以实现具有充足患者招募潜力的多中心试验.
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