China: CDE seek feedback on draft real-world evidence guidance


China: CDE seek feedback on draft real-world evidence guidance

(Source: RAPS 2019-06-06)

China’s Center for Drug Evaluation (CDE) has published draft guidance on using real-world evidence to support drug development. The guideline features practical advice for companies that want to use data from outside randomized controlled trials to demonstrate the safety and efficacy of drugs.

There are precedents for the use of real-world evidence in Chinese drug development programs. Last year, NMPA cleared bevacizumab, sold under the trade name Avastin, for use in combination with platinum-based chemotherapy on the basis of evidence from three real-world studies. Yet, there is limited advice on the application of real-world evidence to Chinese drug development programs.

CDE has published several documents, including an English language text, to address that gap. In its key considerations for using real-world evidence, CDE outlines the current use of such data — both inside China and overseas — and discusses how to evaluate and use this source of information.

The document features sections describing the basics of pragmatic clinical trials, single-arm studies using historical controls and observational research. CDE identifies weaknesses with all the forms of real-world study but does not rule out their use in the generation of evidence to support regulatory decisions.

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