Chapter 24: Novel Strategies in Oncology Clinical Trials: The Use of Biological and Imaging Biomarkers

Novel strategies in oncology clinical trials: The use of biological and imaging biomarkers The gold standard for evaluating an oncology drug candidate's effectiveness is survival. However, the emergence of biotherapeutics for use in oncology has shifted attention to intermediate indicators of progress in patient-treatment evaluations. By evaluating immunological responses to biotherapeutics, insight may be gained into potential therapeutic improvements to optimize dosage, delivery, and combinations with other therapeutics. Evaluation of the immune response requires quantifying the biological changes, or creating “biomarkers,” that can be related to clinical outcomes. As we discuss, both biological biomarkers and imaging biomarkers are emerging to fill this role. The development and application of these biomarkers for use in evaluating oncology biotherapeutics and other drugs has the potential to simplify the arduous drug development pathway. Potential applications of biomarkers include a role in the decision whether to continue development of particular products and in the selection ...

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