title: FDA introductory comments: clinical studies design and evaluation issues.
authors.affiliation: Food and Drug Administration, Rockville, MD 20857, USA.
authors.forename: Janet
authors.initials: J
authors.lastname: Woodcock
mesh_terms: D001499:Bayes Theorem; D002986:Clinical Trials as Topic / Q000379:methods*; D017277:Drug Approval; D004341:Drug Evaluation / Q000379:methods*; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration