“Personalized Oncology: New Paradigms in Clinical Trial Methodology”
Abstract: Cancers are diseases of DNA disfunction. Consequently new diagnostic classification systems based on somatic genomic alterations are rapidly replacing traditional systems based on primary site and histology. A large proportion of the cancer drugs that have been approved by regulatory authorities in the past decade have an intended use for a restricted subset of patients defined by alteration of a gene related to the molecular target of the drug. Much current drug development in oncology involves co-development of a companion in-vitro diagnostic test for selecting the subset of patients who are likely to benefit from the drug. The companion diagnostics are often based on DNA sequencing of patients’ tumors. Progress in the development of effective drugs has increased in oncology. The progress has been based on use of non-traditional clinical trial designs such as enrichment designs in which a relatively narrow subset of patients is selected for randomization instead of the usual broad eligibility trials. Adaptive enrichment designs and run-in designs have been developed for settings where a single candidate predictive biomarker is not known a-priori. There is also considerable interest in basket clinical trials are phase II development studies which accrue patients with a common genomic alteration but a range of histologic types of tumors. I will review some of the new phase II and III designs for biomarker driven clinical trials that have been developed and used in oncology.
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