To randomize or not to randomize - how “quasi-experimental” trials in naturalistic settings will change medical practice.F.W. Frueh, B.C. Agatep, B. Dechairo, C. Ewel, C.L. Sanders, E.J. Stanek, R.S. Epstein. Genetic and pharmacogenetic research is becoming integrated into medical practice at variable pace depending on therapeutic, provider, and patient segmentation. Consumers and providers are becoming aware of the importance of weighing genetic factors when making medical decisions, and the recent market entry of several “consumer genetics” companies promises an unprecedented increase in the amount of genetic information to draw associations between genetic variations and phenotypes. However, this information is collected in uncontrolled, non-randomized, retrospective fashion, leading to significant and often justified criticism of the validity of these associations. This is particularly problematic in situations where this information may be used to make critical clinical decisions. While the prospective randomized controlled trial (RCT) remains the gold standard to demonstrate that a particular intervention exhibits a desired effect, alternative epidemiological and comparative effectiveness study designs may be more suitable to investigate the validity and clinical utility of genetic markers. Presented: 59th Annual Meeting of The American Society of Human Genetics, Honolulu, HI. Link: http://www.ashg.org/2009meeting/pdf/platforms_4up.pdf (Abstract #309) |