On May 29th, 2019, China CDE published the Key Considerations in Using Real-World Evidence to Support Drug Development (Draft Version) for public review. And it’s the first time the concept of Real World Evidence (RWE) was clearly stated by China CDE.
This Key Considerations (Draft) contains five main parts including 1) Introduction, 2) The Definition and Scope of Real-World Evidence on a Conceptual Level, 3) Scenarios Where Real-World Evidence Supports Drug Development and Regulatory Decisions, 4) the Basics of Real-World Research Design, and 5) Evaluation of Real-World Evidence. In the definition part, the real world data (RWD) is defined as ‘data collected from patients’ medications and health status, and/or derived from various daily medical processes’.
And in the Scenarios Where Real-world Evidence Supports Drug Development and Regulatory Decisions part, there are 6 scenarios described:
1) Treatment for rare diseases;
2) Revision of indications or drug combination labeling;
3) Post-marketing evaluation;
4) Clinical development of traditional Chinese medicine hospital preparations;
5) Guiding clinical trial design;
6) Identify the target population.
The extended Bevacizumab treatment regimen in combination with platinum-based chemotherapies is given as an example of China national drug regulatory agencies utilizing RWE in the review practices. Furthermore, the possible strategy of using RWE for the traditional Chinese medicine development which is prepared and used in China local hospitals are discussed in more detail.
Both Chinese and English version of this Draft Key Considerations are available on China CDE website, and the timeline for public opinion feedback is 3 months.
The full English draft version can be downloaded via the link below:
