Center for Medical Statistics, Informatics, and Intelligent Systems, Medical University of Vienna, Vienna, Austria.
Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ, USA.
Trials. 2021 Mar 4;22(1):183. doi: 10.1186/s13063-021-05130-x.
In 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.
A 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.
In 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.
We 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.
近年来，多臂多阶段、无缝自适应和平台试验的流行度有所增加。然而，许多与设计相关的问题以及应评估哪些操作特性来确定特定试验设计的潜在性能的问题仍然存在，并且通常会因这些试验设计的复杂性而变得更加复杂。
进行了系统搜索，以回顾用于平台试验设计的现有软件，其中也包括多臂多阶段试验。该搜索的结果在文献层面和软件层面都有报告，突出了被认为特别有用的软件。
近年来，许多针对平台研究中的单一设计元素的高度专业化软件包已经发布。只有少数开发的软件包提供了广泛的设计灵活性，但其代价是由于商业原因或无法作为即用型解决方案而受到限制，导致访问受限。
我们认为，需要类似 OCTOPUS 的开源模块化软件和协作努力，才能创建利用平台试验潜在提供的所有灵活性并研究其影响的软件。
