Dr. Gradishar on Enriching Targeted Therapy Trials

William J. Gradishar, MD
Published: Tuesday, Feb 19, 2013

William J. Gradishar, MD, Director, Maggie Daley Center for Women's Cancer Care, Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, describes the need to enrich the patient population in a clinical trial that is investigating a novel targeted therapy.

Gradishar believes that trials investigating novel targeted therapies have the potential to have much higher success rates than traditional clinical trials. Enriching trials based on known driver mutations and pathways, which the treatment is meant to target, drives success and lowers the number of trials that fail.

As an example, Gradishar notes that examining a targeted therapy in 50 tumors with 30 different activated pathways may lower the perceived effectiveness of the targeted agent. However, if a trial is enriched based on a pathway or mutation, the agent will be far more likely to achieve its goal.

William J. Gradishar, MD, Director, Maggie Daley Center for Women's Cancer Care, Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, describes the need to enrich the patient population in a clinical trial that is investigating a novel targeted therapy.

Gradishar believes that trials investigating novel targeted therapies have the potential to have much higher success rates than traditional clinical trials. Enriching trials based on known driver mutations and pathways, which the treatment is meant to target, drives success and lowers the number of trials that fail.

As an example, Gradishar notes that examining a targeted therapy in 50 tumors with 30 different activated pathways may lower the perceived effectiveness of the targeted agent. However, if a trial is enriched based on a pathway or mutation, the agent will be far more likely to achieve its goal.


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