How do multi-stage, multi-arm trials compare to the traditional two-arm parallel group design--a reanalysis of 4 trials.
How do multi-stage, multi-arm trials compare to the traditional two-arm parallel group design--a reanalysis of 4 trials.
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DOI：
10.1186/1745-6215-10-21
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发表时间：
2009-04-17
期刊：
影响因子：
2.5
通讯作者：
Royston P
中科院分区：
文献类型：
--
作者：
Barthel FM;Parmar MK;Royston P
为了加速新疗法的评价，作者先前建议多组、多阶段试验设计。在本文中，我们使用在MRC CTU进行的四项癌症试验来评估两阶段多组设计的性能。使用条件自举法评估设计在虚拟中期分析时的性能。有两个主要目标：在中期分析时正确进行/停止试验的错误率，以及通过采用该设计量化资源方面的收益。此外，我们还就中期分析的最佳时机提出了建议。多组、多阶段试验是加速治疗评估过程的有效方法。该设计在I型和II型错误率方面表现良好。
To speed up the evaluation of new therapies, the multi-arm, multi-stage trial design was suggested previously by the authors. In this paper, we evaluate the performance of the two-stage, multi-arm design using four cancer trials conducted at the MRC CTU. The performance of the design at fictitious interim analyses is assessed using a conditional bootstrap approach. Two main aims are addressed: the error rate of correctly carrying on/stopping the trial at an interim analysis as well as quantifying the gains in terms of resources by employing this design. Furthermore, we make suggestions for the best timing of this interim analysis. Multi-arm, multi-stage trials are an effective way of speeding up the therapy evaluation process. The design performs well in terms of the type I and II error rates.
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影响因子：
2
作者：
Royston, P;Parmar, MKB;Qian, W
通讯作者：
Qian, W
影响因子：
168.9
作者：
Seymour, Matthew T.;Maughan, Timothy S.;Stephens, Richard J.
通讯作者：
Stephens, Richard J.
影响因子：
2.7
作者：
Goldman, Bryan;LeBlanc, Michael;Crowley, John
通讯作者：
Crowley, John
影响因子：
2.7
作者：
LAN, KKG;DEMETS, DL
通讯作者：
DEMETS, DL
影响因子：
--
作者：
Pampallona, S;Tsiatis, A;Kim, K
通讯作者：
Kim, K