Saad Everardo Delforge, Buyse Marc
International Drug Development Institute, 1340 Louvain-la-Neuve, Belgium.
Dendrix Research, Sao Paulo 04534-000, Brazil.
Cancers (Basel). 2020 Nov 19;12(11):3442. doi: 10.3390/cancers12113442.
The design of the best possible clinical trials of adjuvant interventions in colorectal cancer will entail the use of both time-tested and novel methods that allow efficient, reliable and patient-relevant therapeutic development. The ultimate goal of this endeavor is to safely and expeditiously bring to clinical practice novel interventions that impact patient lives. In this paper, we discuss statistical aspects and provide suggestions to optimize trial design, data collection, study implementation, and the use of predictive biomarkers and endpoints in phase 3 trials of systemic adjuvant therapy. We also discuss the issues of collaboration and patient centricity, expecting that several novel agents with activity in the (neo)adjuvant therapy of colon and rectal cancers will become available in the near future.
设计针对结直肠癌辅助干预措施的最佳临床试验，需要采用经过时间考验的方法和新颖的方法，以实现高效、可靠且与患者相关的治疗研发。这一努力的最终目标是安全、迅速地将能够影响患者生活的新型干预措施应用于临床实践。在本文中，我们讨论统计学方面的内容，并就优化全身辅助治疗3期试验的试验设计、数据收集、研究实施以及预测性生物标志物和终点的使用提供建议。我们还讨论了合作和以患者为中心的问题，预计在不久的将来会有几种对结肠癌和直肠癌（新）辅助治疗有活性的新型药物问世。
