首先,来看一下某个项目的主要目标和分析终点。
Primary Objective:
Demonstrate the efficacy of XXX versus placebo on induction of clinical remission in adults.
Efficacy Endpoints:
The efficacy endpoints will be formally examined with statistical hypothesis tests conducted
on the efficacy results obtained from adult patients randomized and dosed in Cohort 1.
Cohort 2 is open-label and does not contain a control group, therefore all of the efficacy endpoints will be summarized and described without statistical hypothesis testing.
这里的Efficacy Results,我列举几个:Complete Mayo score、Partial Mayo score、9-point Mayo score、Pediatric Ulcerative Colitis Activity Index (PUCAI)、Clinical Remission......
主要分析出的表格样式如下:
如Efficacy Endpoints所说,假设检验只对Cohort 1人群开展,Cohort 2人群只对分析变量进行统计描述。这里的分析指标是临床缓解率(Clinical Remission),这里的输出统计量有Odds ratio及可信区间、两组差异及可信区间、P值。从这张Table上的Notes看,需要的统计量已经在CMH数据集计算出来,出表的时候只有引用后,调整好模板就好。我们接下来看看,CMH数据集是如何生成的。
没有展示前面人群、分组的设置代码,这个分析的代码基本涵盖了这个试验所需要的所有分组的主要统计分析结果,下面我们SPEC上面的筛选条件(POPN=1, PARAMCD=‘RMW10D1’ and DTYPE=‘NRI’
)筛选出相关数据集的结果。