Recently, the CFDA approved the listing of the class 1 innovative drug pralsetinib capsule declared by blueprint medicine corporation through the priority review and approval procedure and conditions attached. The product is also a pilot variety of Hainan clinical real world data application. The relevant real world research results are complementary to the clinical results, which provides assistance for the evaluation of efficacy and safety of Hainan clinical real world data application in the Chinese advanced non-small cell lung cancer population.

Real world research broadens the data sources for evaluating the safety and effectiveness of products, and plays an auxiliary and supporting role. Real world evidence can be used as a powerful supplement to randomized controlled trials to support drug R & D and regulatory decisions.