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Externally Controlled Studies Using Real-World Data in Patients With Hematological Cancers: A Systematic Review.
Sjoerd J F Hermans1, Niek G van der Maas1, Yvette van Norden1
1Department of Hematology, Erasmus MC Cancer Institute, Erasmus University Medical Center, Rotterdam, the Netherlands.
Real-world data (RWD) external control arms in hematological cancer studies show limitations in applying trial criteria, defining endpoints, and reporting adverse events, challenging study conclusions.
Area of Science:
- Oncology
- Clinical Trials
- Real-World Data
Background:
- The use of real-world data (RWD) for external control arms in prospective studies is growing.
- Balancing the advantages of RWD, such as immediate availability, with evidentiary standards is crucial.
Conclusions:
- Limitations in applying trial criteria, defining endpoints, and reporting adverse events were observed in RWD external control arms.
- These methodological inconsistencies may challenge the validity of conclusions drawn from RWD studies in hematological cancers.
- Further standardization is needed to ensure the reliability of RWD in clinical research.
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