意向治疗分析(intention to treat analysis, ITT)、接受治疗分析(as-treated
analysis,AT)、完成治疗分析(per protocal PP)有何不同? http://www.dxy.cn/bbs/topic/29636437 As treated As-treated analysis has the general idea of comparing the subjects with the treatment regimen that they received. It does not consider which treatment they were assigned for the treatment. Intention to treat analysis Randomized clinical trials analyzed by the intention-to-treat (ITT) approach provide fair comparisons among the treatment groups because it avoids the bias associated with the non-random loss of the participants. The basic ITT principle is that participants in the trials should be analysed in the groups to which they were randomized, regardless of whether they received or adhered to the allocated intervention. However, medical investigators often have difficulties in accepting ITT analysis because of clinical trial issues like missing data or adherence to protocol. Per protocol This analysis can only be restricted to the participants who fulfil the protocol in the terms of the eligibility, interventions, and outcome assessment. This analysis is known as an "on-treatment" or "per protocol" analysis. Also, the per-protocol restricts the comparison of the treatments to the ideal patients, that is, those who adhered perfectly to the clinical trial instructions as stipulated in the protocol. This population is classically called the per-protocol population and the analysis is called the per-protocol-analysis. A per-protocol analysis envisages determining the biological effect of the new drug. However, by restricting the analysis to a selected patient population, it does not show the practical value of the new drug. |
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