Janssen Research and Development, Titusville, NJ, USA.
Pfizer Inc, Groton, CT, USA.
Contemp Clin Trials. 2020 Apr;91:105962. doi: 10.1016/j.cct.2020.105962. Epub 2020 Feb 20.
Mobile sensors offer enormous potential for the collection of informative clinical endpoints in clinical trials to support regulatory decision making and product labelling. There are currently no specific guidelines on the information needed to enable regulators to review and accept proposed endpoints derived from mobile sensors for use in drug development trials.
The purpose of this working group report is to recommend the structure and content of an evidence dossier intended to support whether a clinical endpoint derived from mobile sensor data is fit-for-purpose for use in regulatory submissions for drug approvals.
The structure and content of a dossier to provide evidence supporting the use of a sensor-derived clinical endpoint is described. Sections include clinical endpoint definition and positioning, the concept of interest, the context of use, clinical validation and interpretation, study implementation, and analytical validity with sensor performance verification in support of the selected sensor.
In the absence of definitive regulatory guidance, this report provides a considered approach to compiling a comprehensive body of evidence to justify acceptance of mobile sensors for support of new drug applications.
移动传感器在临床试验中收集有意义的临床终点数据方面具有巨大潜力，可支持监管决策和产品标签。目前，关于监管机构审查和接受源自移动传感器的建议终点数据，以用于药物开发试验的信息，还没有具体的指南。
本工作组报告的目的是建议一个证据档案的结构和内容，旨在支持源自移动传感器数据的临床终点是否适合在药物批准的监管提交中使用。
描述了提供支持使用传感器衍生临床终点的证据的档案结构和内容。各部分包括临床终点定义和定位、关注概念、使用背景、临床验证和解释、研究实施，以及传感器性能验证的分析有效性，以支持选定的传感器。
在缺乏明确监管指南的情况下，本报告提供了一种综合全面的方法来编制证据，以证明接受移动传感器支持新药申请是合理的。
