The feasibility of using real world data as external control arms in oncology trials
Publication date
2025-03
Authors
Lin, Lishi
Lucassen, Merel J.J.
van der Noort, Vincent
Egberts, A.C.G.
Beijnen, Jos
Huitema, Alwin D.R.
Editors
Advisors
Supervisors
Document Type
Article
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Abstract
Before real world data (RWD)-derived external control arms (ECAs) can be applied in clinical trials within the field of oncology, it must be determined whether these ECAs can function as appropriate and reliable control arms. This review provides an overview of studies in which RWD-derived ECAs were constructed and compared to a randomized clinical trial (RCT) arm. RWD-derived ECAs had similar survival outcomes as the RCT arm of comparison in six of the eight included studies. Therefore, when performing RCTs is not feasible, RWD-derived ECAs can act as control arms in single-arm clinical trials, provided that suitable RWD sources are used and suitable methodological decisions are made.
Keywords
external control arm, oncology, real world data, Pharmacology, Drug Discovery
Citation
Lin, L, Lucassen, M J J, van der Noort, V, Egberts, T C G, Beijnen, J H & Huitema, A D R 2025, 'The feasibility of using real world data as external control arms in oncology trials', Drug Discovery Today, vol. 30, no. 3, 104324. https://doi.org/10.1016/j.drudis.2025.104324