快速检索
年期检索
摘要： Objective To analyze the value of EU real-world evidence (RWE) in
supporting the expanded indications for drugs and to provide reference
for the decision-making of expanding drug indications supported by RWE
in China. Methods By searching relevant domestic and foreign literature
and case analysis, the practice of the RWE of EU to support the
expansion indications for drugs was investigated. Results and Conclusion
The EU uses RWE to
carry out adaptive path research, which provides a
new idea for drug R&D and approval. Besides, it also provides
evidence in supporting the research of expanded indications for drugs.
With the increasing cognition of RWE, it will play a key role in medical
and regulatory decisions in China.
