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  • ¡°Dualized RWD collection for Kymriah is inefficient¡±
  • by Lee, Tak-Sun | translator Alice Kang | May 11, 2022 05:55am
Assistant Research Fellow Ji-Hye Byun at HIRA requests ¡®unification of information management organizations)
¡°Separate data collection by the MFDS and HIRA comes as a burden to HCPs¡±
With the registration of the ultra-expensive one-shot treatment Kymriah, the opinion was raised that a plan should be prepared to ensure the efficiency of the system by standardizing the dualized real clinical data (RWD) collection required by different institutions.

That the separate collection of data by the Ministry of Food and Drug Safety and the Health Insurance Review and Assessment Service is a burden on the medical staff.

Ji-Hye Byun, Assistant Research Fellow of the Evidence-based Research Division at HIRA claimed so in the 22nd issue of ¡®HIRA¡¯ that was recently published.

Kymirah is the world¡¯s first chimeric antigen receptor T-cell (CAR-T) therapy that was developed by Novartis Korea. The drug
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