Predictive biomarkers for personalised anti-cancer drug use: Discovery to clinical implementation

Schematic of biomarker development process, illustrating the key stages of discovery, qualification, validation and clinical implementation (discussed in detail in the text). Also illustrates alternative views on the biomarker development process from the position of different stakeholders and how this might interact with the scientific process (PD=pharmacodynamic).

This design randomises patients to biomarker-based and non-biomarker-based treatments first then assigns biomarker-positive patients to treatment A and biomarker-negative patients to treatment B. Non-biomarker-based treatment assigns patients to treatment A only. Modified from Sargent et al.²⁷

This design randomises patients to biomarker-based and non-biomarker-based treatments first then assigns biomarker-positive patients to treatment A and biomarker-negative patients to treatment B. Non-biomarker-based strategy randomises patients to both treatments. Modified from Sargent et al.²⁷

This design divides patients initially according to biomarker status and then randomises each group to both treatments. Modified from Sargent et al.²⁷

The trend of cancer predictive biomarkers published literature: The publications were searched for in Medline, Embase and SCOPUS using all forms and synonyms of the search terms ‘biomarker’, ‘prediction’ and ‘cancer’ and duplicates were removed. There appears to be a considerable increase in the number of cancer predictive biomarkers published papers since the year 2000.