Wang Yunfei, Ivanova Anastasia
Department of Biostatistics, The University of North Carolina at Chapel Hill, Chapel Hill, NC, 27599-7420, USA.
Pharm Stat. 2015 Mar-Apr;14(2):102-7. doi: 10.1002/pst.1662. Epub 2014 Nov 19.
The goal of a phase I clinical trial in oncology is to find a dose with acceptable dose-limiting toxicity rate. Often, when a cytostatic drug is investigated or when the maximum tolerated dose is defined using a toxicity score, the main endpoint in a phase I trial is continuous. We propose a new method to use in a dose-finding trial with continuous endpoints. The new method selects the right dose on par with other methods and provides more flexibility in assigning patients to doses in the course of the trial when the rate of accrual is fast relative to the follow-up time.
肿瘤学中一期临床试验的目标是找到一个具有可接受的剂量限制毒性率的剂量。通常，当研究一种细胞抑制药物或使用毒性评分定义最大耐受剂量时，一期试验的主要终点是连续性的。我们提出一种新方法，用于具有连续性终点的剂量探索试验。该新方法与其他方法一样能选择合适的剂量，并且在入组率相对于随访时间较快的试验过程中，在将患者分配至各剂量组时提供了更大的灵活性。
