Eligibility criteria for phase I clinical trials: tight vs loose?
Eligibility criteria for phase I clinical trials: tight vs loose?
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DOI：
10.1007/s00280-019-03801-w
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发表时间：
2019-05-01
影响因子：
3
通讯作者：
Lu, David
中科院分区：
文献类型：
--
作者：
Malik, Laeeq;Lu, David
目的本研究的目的是分析一系列 I 期癌症临床试验，根据患者的资格标准检查和比较试验方案。方法我们评估了 1991 年至 2016 年间在癌症治疗和研究中心（圣安东尼奥）药物开发研究所进行的所有剂量递增 I 期试验方案，以及可获取或已发表的结果。根据几个资格参数，研究方案被分为非限制性 (NRP) 或限制性 (RP)。采用 Fisher 精确检验和卡方检验来比较 NRP 和 RP 的特征。 结果 在筛选的 284 个方案中，本综述纳入了 231 个实体瘤剂量递增 I 期试验方案（具有可获取的结果）。 NRP 145 例（涉及 3190 例患者），RP 86 例（涉及 1892 例患者）。 NRP 和 RP 排除标准的中位数分别为 14 和 23。使试验方案受到限制的最常见原因是 ECOG
Purpose The purpose of the current study is to analyze a series of phase I cancer clinical trials, examine and compare trial protocols based on patients' eligibility criteria.Methods We evaluated all dose escalation phase I trial protocols with accessible or published results performed at Institute for Drug Development, Cancer Therapy and Research Center (San Antonio) between 1991 and 2016. Study protocols were categorized as non-restrictive (NRP) or restrictive (RP) based on several eligibility parameters. Fisher's Exact and Chi-square tests were used to compare characteristics of NRP and RP.Results Of 284 protocols screened, 231 dose escalation phase I trial protocols (with accessible results) of solid tumors were included in this review. There were 145 NRP (involving 3190 patients) and 86 RP (involving 1892 patients). The median number of exclusion criteria for NRP and RP were 14 and 23, respectively. The most common reasons that made trial protocol to be restrictive were ECOG