Assurance calculations for planning clinical trials with time-to-event outcomes.
Assurance calculations for planning clinical trials with time-to-event outcomes.
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DOI：
10.1002/sim.5916
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发表时间：
2014-01-15
影响因子：
2
通讯作者：
Oakley, Jeremy E.
中科院分区：
文献类型：
--
作者：
Ren, Shijie;Oakley, Jeremy E.
我们考虑在临床试验计划中使用保证方法。在替代功率计算的保证方法中，我们通过得出有关治疗效果的先验概率分布来计算临床试验获得成功结果的概率。这通常是一种混合贝叶斯-频率法，因为通常假定将使用频率法假设检验来分析试验数据，从而先验分布仅用于计算在频率法检验中观察到期望结果的概率。我们认为，评估临床试验成功的可能性是试验计划过程中有用的一部分。我们开发了保证方法，以适应生存结果衡量，假设参数和非参数模型。我们还为每个生存模型开发了预先的启发式程序，以便更容易和更可靠地执行保证计算。我们已经为实现我们的方法提供了免费软件。
We consider the use of the assurance method in clinical trial planning. In the assurance method, which is an alternative to a power calculation, we calculate the probability of a clinical trial resulting in a successful outcome, via eliciting a prior probability distribution about the relevant treatment effect. This is typically a hybrid Bayesian-frequentist procedure, in that it is usually assumed that the trial data will be analysed using a frequentist hypothesis test, so that the prior distribution is only used to calculate the probability of observing the desired outcome in the frequentist test. We argue that assessing the probability of a successful clinical trial is a useful part of the trial planning process. We develop assurance methods to accommodate survival outcome measures, assuming both parametric and nonparametric models. We also develop prior elicitation procedures for each survival model so that the assurance calculations can be performed more easily and reliably. We have made free software available for implementing our methods.
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影响因子：
7.2
作者：
Hiance, Anne;Chevret, Sylvie;Levy, Vincent
通讯作者：
Levy, Vincent
影响因子：
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作者：
Chuang-Stein, Christy;Yang, Ruoyong
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FREEDMAN, LS
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作者：
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通讯作者：
SINGPURWALLA, ND
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作者：
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通讯作者：
SUN, DC