Using real-world evidence in haematology

Most new drug approvals are based on data from large randomized clinical trials (RCTs). However, there are sometimes contradictory conclusions from seemingly similar trials and generalizability of conclusions from these trials is limited. These considerations explain, in part, the gap between conclu...

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Veröffentlicht in:Best practice & research. Clinical haematology 2024-03, Vol.37 (1), p.101536-101536, Article 101536
Hauptverfasser: Passamonti, Francesco, Corrao, Giovanni, Castellani, Gastone, Mora, Barbara, Maggioni, Giulia, Della Porta, Matteo Giovanni, Gale, Robert Peter
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Sprache:eng
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Zusammenfassung:Most new drug approvals are based on data from large randomized clinical trials (RCTs). However, there are sometimes contradictory conclusions from seemingly similar trials and generalizability of conclusions from these trials is limited. These considerations explain, in part, the gap between conclusions from data of RCTs and those from registries termed real world data (RWD). Recently, real-world evidence (RWE) from RWD processed by artificial intelligence has received increasing attention. We describe the potential of using RWD in haematology concluding RWE from RWD may complement data from RCTs to support regulatory decisions.
ISSN:1521-6926
1532-1924
DOI:10.1016/j.beha.2024.101536