Stanley M. Huff, MD, is board certified in Clinical Pathology, and in Clinical Informatics. He has worked in the area of medical vocabularies and medical database architecture for the past 25 years. He is currently a fellow of the American College of Medical Informatics, a co-chair of the LOINC Committee, a co-chair of the Health Level 7 (HL7) Clinical Information Modeling Initiative (CIMI), the chair of the Healthcare Services Platform Consortium (HSPC), and the immediate past chair of HL7. He is a former member of the Office of the National Coordinator for Health Information Technology (ONC) Health Information Technology (HIT) Standards Committee. Dr. Huff received his BS degree in Chemistry from Brigham Young University and his MD degree from the University of Utah.
Modernizing clinical trials is the U.S. FDA priority. As more diseases are being redefined based on genomic subtype, researchers have more novel targets and more opportunities to precisely modulate or even repair the basic biological drivers of illness. Precision guided medicines can demonstrate strong efficacy signals in early clinical trials, including in trials where small groups of patients are selected based on biomarkers or other criteria suggesting they’re likely to benefit. These trials can potentially allow earlier regulatory assessment of benefit and risk. When the FDA can make a positive approval decision, patients can gain earlier access to important new therapeutic options. To take advantage of these innovations, the FDA is also seeking new ways to modernize its approaches to accommodate these novel opportunities.