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Review
. 2024 Mar;37(1):101536.
doi: 10.1016/j.beha.2024.101536. Epub 2024 Jan 27.

Using real-world evidence in haematology

Francesco Passamonti  1 , Giovanni Corrao  2 , Gastone Castellani  3 , Barbara Mora  4 , Giulia Maggioni  5 , Matteo Giovanni Della Porta  5 , Robert Peter Gale  6
Affiliations
Review

Using real-world evidence in haematology

Francesco Passamonti et al. Best Pract Res Clin Haematol. 2024 Mar.

Abstract

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.

Keywords: Artificial intelligence; Haematological cancers; Leukemia; Lymphoma; Real world data; Real world evidence.

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Conflict of interest statement

Declaration of competing interest RPG is a consultant to BeiGene Ltd., Fusion Pharma LLC, La Jolla NanoMedical Inc., Mingsight Parmaceuticals Inc. and CStone Pharmaceuticals; advisor to Antegene Biotech LLC, Medical Director, FFF Enterprises Inc.; partner, AZAC Inc.; Board of Directors, Russian Foundation for Cancer Research Support; and Scientific Advisory Board: StemRad Ltd: F Passamonti received honoraria for lectures and advisory boards from Novartis, GSK, Bristol-Myers Squibb/Celgene, Sierra Oncology, AbbVie, Janssen, Roche, AOP Orphan, Karyopharma, Kyowa Kirin and MEI, Sumitomo.

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