Genetics. FDA races in wrong direction.
Despite recent genetic evidence and the promise of individualized medicine, there is a continuing interest in using self-identified categories of race and ethnicity as variables in scientific and medical research. The U.S. Food and Drug Administration recently proposed a standardized approach for the collection of race and ethnicity data in clinical trials. We believe that this move fails to acknowledge new scientific data and recommend that relevant data from individuals be collected and used rather than broad group statistics. We also encourage that increased funding be committed to this important issue.
Haga
Susanne B
SB
Center for the Advancement of Genomics, Rockville, MD 20850, USA.
Venter
J Craig
JC
D002986:Clinical Trials as Topic; D005006:Ethnicity / Q000235:genetics; D005787:Gene Frequency; D014644:Genetic Variation; D017408:Guidelines as Topic; D006801:Humans; D010597:Pharmacogenetics; D044469:Racial Groups / Q000235:genetics; D014481:United States; D014486:United States Food and Drug Administration