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首页> 外文期刊>Journal of the Royal Statistical Society. Series C, Applied statistics >Statistics for weighing benefits and harms in a proposed genetic substudy of a randomized cancer prevention trial
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Statistics for weighing benefits and harms in a proposed genetic substudy of a randomized cancer prevention trial

机译：在一项随机癌症预防试验的拟议遗传研究中权衡利弊的统计数据

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摘要

When evaluating potential interventions forcancer prevention, it is necessary to compare benefits and harms. With new study designs, new statistical approaches may be needed to facilitate this comparison. A case in point arose in a proposed genetic substudy of a randomized trial of tamoxifen versus placebo in asymptomatic women who were at high risk for breast cancer. Although the randomized trial showed that tamoxifen substantially reduced the risk of breast cancer, the harms from tamoxifen were serious and some were life threatening. In hopes of finding a subset of women with inherited risk genes who derive greater benefits from tamoxifen, we proposed a nested case-control study to test some trial subjects for various genes and new statistical methods to extrapolate benefits and harms to the general population. An important design question is whether or not the study should target common low penetrance genes. Our calculations show that useful results are only likely with rare high penetrance genes.
机译：在评估预防癌症的潜在干预措施时，有必要比较其利弊。对于新的研究设计，可能需要新的统计方法来促进这种比较。他莫昔芬与安慰剂的一项随机试验的拟议遗传学研究的一个实例就是这样，该试验对患有乳腺癌高风险的无症状女性进行了研究。尽管这项随机试验表明他莫昔芬大大降低了患乳腺癌的风险，但他莫昔芬的危害却是严重的，其中一些威胁生命。为了寻找能够从他莫昔芬中获得更大收益的具有遗传风险基因的女性子集，我们提出了一项嵌套的病例对照研究，以测试一些试验对象的各种基因，并提出了新的统计方法，以推断对普通人群的益处和危害。一个重要的设计问题是该研究是否应针对常见的低渗透性基因。我们的计算表明，有用的结果只有在稀有的高渗透性基因中才有可能。

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