RPSFT法在临床试验转组研究中的应用

Correcting for Non-compliance in Randomized Trials Using Rank Preserving Structural Failure Time Models

目的介绍等级结构保留失效时间模型(rank preserving structural failure time models,RPSFT)在临床试验转组研究中的应用。方法以一项存在转组情况的阿帕替尼片的随机双盲、平行对照、多中心Ⅲ期临床研究为例,应用RFSFT法对转组数据进行校正,评估校正前后两组中位生存时间及组间风险比估计值变化情况。结果经过RPSFT法校正后,对照组的中位生存时间校正前高于校正后、组间风险比校正前也高于校正后,校正后两种治疗的长期效果差异更接近真实情况。结论 RPSFT法是英国国家健康与临床评价研究所(NICE)认可的方法,在转组临床试验研究中具有较大应用价值。

Objective To introduce rank preserving structural failure time models in the application of randomized trials with crossover. Methods Based on an randomized,duble blind,parallel group,multi- center,phase III Apatinib clinical trials with crossover,RPSFT models are developed,then we accessed the changes of the median survival time of control group and hazard ratio between groups. Results Both the median survival time of control group and hazard ratio between groups are higher than before corrected,which makes the difference of efficacy more closer to true effect. Conclusion NICE appraisal acknowledge RPSFT as being more methodologically robust,which is of high value in the application of randomized trials with crossover.