Systematic review of available software for multi-arm multi-stage and platform clinical trial design

被引:12
|
作者
Meyer, Elias Laurin [1 ]
Mesenbrink, Peter [2 ]
Mielke, Tobias [3 ]
Parke, Tom [4 ]
Evans, Daniel [5 ]
Koenig, Franz [1 ]
机构
[1] Med Univ Vienna, Ctr Med Stat Informat & Intelligent Syst, Vienna, Austria
[2] Novartis Pharmaceut, One Hlth Plaza, E Hanover, NJ USA
[3] Janssen Cilag GmbH, Neuss, Germany
[4] Berry Consultants, Abingdon, Oxon, England
[5] Pfizer R&D UK Ltd, Sandwich, Kent, England
基金
欧盟地平线“2020”;
关键词
CONFIRMATORY ADAPTIVE DESIGNS;
D O I
10.1186/s13063-021-05130-x
中图分类号
R-3 [医学研究方法]; R3 [基础医学];
学科分类号
1001 ;
摘要
BackgroundIn recent years, the popularity of multi-arm multi-stage, seamless adaptive, and platform trials has increased. However, many design-related questions and questions regarding which operating characteristics should be evaluated to determine the potential performance of a specific trial design remain and are often further complicated by the complexity of such trial designs.MethodsA systematic search was conducted to review existing software for the design of platform trials, whereby multi-arm multi-stage trials were also included. The results of this search are reported both on the literature level and the software level, highlighting the software judged to be particularly useful.ResultsIn recent years, many highly specialized software packages targeting single design elements on platform studies have been released. Only a few of the developed software packages provide extensive design flexibility, at the cost of limited access due to being commercial or not being usable as out-of-the-box solutions.ConclusionsWe believe that both an open-source modular software similar to OCTOPUS and a collaborative effort will be necessary to create software that takes advantage of and investigates the impact of all the flexibility that platform trials potentially provide.
引用
收藏
页数:14
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