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Biomarkers in oncology drug development
Darren R Hodgson1, Robin D Whittaker, Athula Herath
1Oncology Therapy Area, AstraZeneca, Alderley Park, Macclesfield, Cheshire SK10 4TG, UK.
Abstract:
Biomarker measurements have become an essential component of oncology drug development, particularly so in this era of targeted therapies. Such measurements ensure that clinical studies are testing our biological hypotheses and can help make the difficult decisions required to choose which drugs to stop developing or de-prioritise. For those drugs taken forward, biomarker measurements may also help choose the appropriate dose, schedule and patient population. In this review we discuss the intrinsic properties of biological sample based efficacy measurements and how these relate to their implementation in oncology drug development by way of points to consider and examples.
Insights
Biomarker measurements are crucial for oncology drug development, guiding decisions on drug viability, dosage, and patient selection in targeted therapy. This review explores their properties and implementation in cancer research.
Area of Science:
- Oncology
- Pharmacology
- Biomarkers
Background:
- Biomarker measurements are integral to modern oncology drug development.
- Targeted therapies rely heavily on these measurements to validate biological hypotheses.
- Biomarkers aid in critical decision-making processes for drug advancement or termination.
Purpose of the Study:
- To review the intrinsic properties of biological sample-based efficacy measurements.
- To discuss the implementation of these measurements in oncology drug development.
- To provide considerations and examples for using biomarkers in clinical studies.
Main Methods:
- Literature review of biomarker applications in oncology drug development.
- Analysis of intrinsic properties of biological sample-based efficacy measurements.
- Case study examples illustrating biomarker implementation.
Main Results:
- Biomarker measurements confirm biological hypotheses in clinical trials.
- They inform decisions regarding drug prioritization and discontinuation.
- Biomarkers assist in optimizing dose, schedule, and patient populations for effective therapies.
Conclusions:
- Effective implementation of biomarker measurements is key to successful oncology drug development.
- Understanding biomarker properties enhances their utility in clinical decision-making.
- Biomarkers are essential tools for advancing targeted cancer therapies.
