title: The FDA clinical trial process: effectuating change in the regulatory framework governing clinical trials to account for the historical shift from "traditional" to "new" phase I trials.
authors.affiliation: Case Western Reserve University School of Law, USA.
authors.forename: Jamie L
authors.initials: JL
authors.lastname: Aldes
mesh_terms: D002986:Clinical Trials as Topic / Q000266:history / Q000331:legislation & jurisprudence; D017321:Clinical Trials, Phase I as Topic / Q000331:legislation & jurisprudence* / Q000592:standards; D006075:Governing Board; D033161:Government Regulation / Q000266:history; D049673:History, 20th Century; D049674:History, 21st Century; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration / Q000266:history