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Evidence-Based Oncology The American Society of Clinical Oncology Annual Meeting, 2015

New Oncology Clinical Trial Designs: What Works and What Doesn't?

Surabhi Dangi-Garimella, PhD
Basket and umbrella studies as well as adaptive enrichment design strategies represent novel approaches to testing targeted therapeutics in oncology, and a session at ASCO's annual meeting discussed the nuts and bolts of these design strategies.

Several criteria influence the drug selection process, she said. The molecules could be FDA-approved for a predictive indication, or have a biomarker; investigational drugs can be included if they have predictive molecular value.

Dahlberg concluded: “Basket design can accelerate the delivery of the right treatment to a patient, but it requires that strong biomarkers be associated with the drug. Additionally, heterogeneity in response across disease types is a primary consideration, and clonal variation has to be adapted during trial design.”

Reference

1. NCI-Molecular Analysis for Therapy Choice Program (NCI-MATCH). National Cancer Institute website. http://www.cancer.gov/about-cancer/treatment/clinical-trials/nci-supported/nci-match. Accessed June 12, 2015.
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