Research Methods for Clinical Trials in Personalized Medicine: A Systematic Review

摘要: Background: Personalized medicine, the notion that an individual’s genetic and other characteristics can be used to individualize diagnosis, treatment prevention of disease, is active exciting area research, with tremendous potential improve health society. Methods: Seventy-six studies using personalized medicine analysis techniques published from 2006 2010 in six high-impact journals Journal American Medical Association, National Cancer Institute, Lancet, Nature, Nature Medicine, New England Medicine were reviewed. Selected articles manually selected based on reporting use information stratify subjects analyses association between biomarkers patient clinical outcomes. Results: We found considerable variability limited consensus approaches. Approaches could largely classified as data-driven, seeking discovery through statistical data, or knowledge-driven, relying heavily prior biological information. Some took a hybrid approach. Eliminating two retracted after publication, 56 remaining 74 (76%) cancerrelated. Conclusions: Much work needed standardize methods for finding biomarkers, validating results, efficiently optimizing better individual strategies. Several promising new analytic approaches are available should considered future medicine.