Genomic Medicine: Levels of Evidence for Proving Clinical Utility
Thomas J. White, Ph.D. Regents' Lecturer, UC Berkeley 2012-2013
The application of massively parallel genomic DNA sequencing methods is transforming the practice of medicine – particularly in oncology where companion diagnostic tests are intended to aid physicians in selecting appropriate therapies for individual patients. In a rapidly changing healthcare environment, the level of evidence sufficient for making clinical decisions may differ substantially depending on the perspectives of patients, oncologists, payors and regulatory agencies. While prospective randomized clinical trials represent the highest level of evidence for clinical utility of a new test or drug, they may no longer be feasible for recruiting patients with a complex spectrum of genetic biomarkers and several potential drug treatments. The field is moving toward the acceptance by stakeholders of different evidentiary standards for clinical utility of tests for different medical conditions.
Dr. White received his PhD in Biochemistry from UC Berkeley and did postdoctoral research at the University of Wisconsin, Madison. He was VP of Research at Cetus Corporation, Senior VP of R&D at Roche Molecular Systems, and Chief Scientific Officer at Celera, where he was responsible for the development of multiple applications, tests and products based on PCR (polymerase chain reaction) technology in basic research, diagnostics, forensics and molecular evolution.
This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education through the joint sponsorship of the University of California, San Francisco School of Medicine (UCSF) and the UCSF/UC Hastings Consortium on Law, Science & Health Policy. UCSF is accredited by the ACGME to provide continuing medical education for physicians. Presenting faculty has disclosed no conflict of interest for this event.