Medable Inc, Palo Alto, CA, USA.
Gwaltney Consulting, Westerly, RI, USA.
Ther Innov Regul Sci. 2022 Jul;56(4):531-535. doi: 10.1007/s43441-022-00412-1. Epub 2022 May 9.
Bring-your-own-device (BYOD) methods for collecting patient-reported outcome (PRO) data in clinical trials can decrease patient burden and improve data quality. However, adoption of BYOD in clinical trials is limited by the absence of publicly available case studies where BYOD PRO data supported regulatory medical product approvals. Anecdotally, we are aware of multiple examples where efficacy and safety label claims were based on BYOD PRO data; however-except for one-these examples have not been made public. The absence of these case studies can lead sponsors to be hesitant to use BYOD for capturing primary and secondary PRO-based endpoints in their trials. This commentary outlines the context of the issue faced and concludes with a call for sponsor transparency with regard to BYOD use through publicizing where approved labeling claims were based on BYOD data. We suggest how this data could be systematically captured going forward. Sharing this information will benefit the clinical trials enterprise by increasing confidence in the utilization of BYOD and provide opportunities to enhance patient-centricity.
在临床试验中采用自带设备（BYOD）方法来收集患者报告的结局（PRO）数据，可以减轻患者负担并提高数据质量。然而，由于缺乏公开的案例研究，BYOD PRO 数据支持监管医疗产品批准，因此临床试验中对 BYOD 的采用受到限制。据我们所知，有多个例子表明疗效和安全性标签声明是基于 BYOD PRO 数据的；然而，除了一个例子之外，这些例子都没有公开。由于缺乏这些案例研究，赞助商可能不愿意在试验中使用 BYOD 来收集基于主要和次要 PRO 的终点。本评论概述了所面临问题的背景，并呼吁赞助商通过公开基于 BYOD 数据的批准标签声明来提高使用 BYOD 的透明度。我们建议如何系统地捕捉这些数据。分享这些信息将通过提高对 BYOD 的使用信心并为增强以患者为中心的机会，使临床试验行业受益。
