China’s CDE Publishes a Draft of “Guiding Principles For Applying Patient-Reported Outcomes In Clinical Research”

Increasing emphasis on patient-focused drug development

On September 3, 2021, China’s Center for Drug Evaluation (CDE) published a draft of “Guiding Principles for Applying Patient-Reported Outcomes in Clinical Research (huanzhe baogao jieju zai yaowu linchuang yanjiu Zhong yingyong de zhidao yuanze),” soliciting public comments on the draft.  While the period for the public feedback closed on October 3, the draft speaks to the increasing interest in incorporating patient voices and experiences into drug development and clinical research in general in China. The whole draft extensively cites Western academic literature and policy documents from the European Medicines Agency and the U.S. Food and Drug Administration. This shows that the Chinese government is increasingly joining the global patient-focused drug development bandwagon.

The draft primarily defines PROs as quantitatively measurable ones, and hence it extensively discusses how to get quantitative scales right through a rigorous research process – a literature review, expert interviews (Delphi method), and iterative improvements of quantitative scales through pilot and formal research with the study population. The draft discusses the benefits that the use of electronic patient-reported outcomes, or ePROs, may bring compared to the paper-based collection of PROs, such as accuracy, completeness, flexibility, safety, and data privacy. In addition to using telephone calls, it imagines that cell phones, tablets, computers, and even wearable devices can be used as effective ePRO collection methods.

Importantly for Clinigma®, the guidance draft discusses the necessity of localizing trial manuals into the Chinese context, unless there is already an officially approved Chinese version. Our rigorous research methodology, matched with our team of global experts, is perfectly suited for ensuring that distinct patient voices from various locales like China are incorporated into drug development processes.

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