Incorporation of Biomarker Assessment in Novel Clinical Trial Designs: Personalizing Brain Tumor Treatments
Advances in molecular genetics have aided the identification of potential biomarkers with significant clinical promise in neurooncology. These advances and the evolution of targeted therapeutics necessitate the development and incorporation of innovative clinical trial designs that can effectively validate and assess the clinical utility of biomarkers. In this article, we review the use and potential of several such designs in neurooncology trials in order to support the development of personalized treatment approaches for brain tumor patients.
KeywordsBiomarkers Glioma Neurooncology trials Biomarker enrichment design Marker by treatment interaction design Adaptive design
E. Galanis: none; W. Wu: none; J. Sarkaria: unrestricted grants from Merck, Millenium, Basilea, Bristol-Meyers Squibb, Array Biopharma, and Lilly, and royalties from Wyeth; S. M. Chang: research support from Novartis and Schering; H. Colman: no direct conflicts, but prior relationships include consultant/scientific advisor (Castle Biosciences) and scientific advisory boards (Schering-Plough, Bayer/Onyx); D. Sargent: none; D. A. Reardon: served on advisory boards for Genentech/Roche, received speakers’ fees for Genentech/Roche and Schering/Merck, and also has received consultancy compensation from Merck KGaA. Supported in part by CA-108961.
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