Aspectos metodológicos y éticos de la farmacogenómica en los ensayos clínicos aleatorizados

one of the greatest advances of the modern medicine has been the report of the complete sequence of the human genome. this has brought as a consequence an evolution in the design of the clinical research, in special of the randomized clinical trials (rcts). the pharmacogenomics, a powerful tool for the prediction of pharmacological effects based on the genotype of the studied subjects, promises to be very useful next years for the development of the pharmaceutical industry. with the present integration of the pharmacogenomical methods to the investigation and development of new medicines it may start a new era in the medical prescription producing more individualized therapies, reduction of adverse events in the patients and in addition a faster development of new medicines in a more cost-effective way. nevertheless new methodological, ethical and social challenges appear that will have to be solved simultaneously, to allow a legal use of the vast information generated by the genetic information.