China's Patient-Reported Outcomes Regulation in Clinical Trials

This document is a news article discussing the draft guidance released by China's Center for Drug Evaluation regarding the use of patient-reported outcomes (PROs) in clinical studies. It outlines how PROs can evaluate drug efficacy and reflect safety and quality of life. The article describes the role of various technologies such as patient diaries, smartphones, and wearable monitors in capturing these outcomes. The draft guidance proposes two categories of PROs: traditional written records and digital recordings through devices. It emphasizes the importance of well-founded PROs to serve as primary or secondary endpoints in clinical studies. The document also addresses data reliability, security, and the implications of adopting PROs, especially in enhancing patient participation in trials amidst growing demand. It highlights that while the PRO concept is gaining traction, it requires careful monitoring to ensure data quality and usability. Public comments on the draft are being collected until 3 October.