• Peter Gibbs, Wei Hong, and Jeanne Tie.
• Division of Personalised Oncology, Walter and Eliza Hall Institute, Parkville, Melbourne, Australia. peter.gibbs@mh.org.au.
• Bmc Med. 2023 Sep 7; 21 (1): 343343.

BackgroundThere is an increasing focus over time on the discovery and validation of biomarkers in cancer medicine, which can inform the identification of patients that are most likely to benefit from treatment, which therapy is most likely to be effective, and treatments that may not be safe. BODY: Creating the necessary evidence base for biomarker-informed management is a different challenge to developing a new therapy, and many biomarkers have been adopted into routine clinical practice without phase III randomised studies where the primary endpoint was to evaluate the direct impact of a biomarker-informed approach. This has generated a robust discussion in the research and clinical community regarding the most appropriate trial methodologies for biomarker validation, and the level of evidence required to support the incorporation of individual biomarker-driven approaches as a standard of care. This ongoing debate is key to optimising clinical trial design and ultimately delivering the best possible care to patients in an environment increasingly focused on personalised and patient-focused management.ConclusionOngoing deliberation as to the optimal design of biomarker-driven clinical trials is critical to informing future clinical trial design and will ultimately greatly benefit patients and the clinicians that care for them.© 2023. BioMed Central Ltd., part of Springer Nature.

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