title: Defining the regulatory role of ambulatory blood pressure monitoring. ABPM Steering Committee.
abstract: Our division is in a privileged position to study the usefulness of ABPM in the clinical development of antihypertensive agents. Most trials involving ABPM are commercially sponsored, and in due course, much of that data is presented to the Division. As such studies become more prominent in drug development, the Agency must make decisions on how such data are analyzed and interpreted. These should be seen as this project's short-term goals. In the longer term, the accumulation of ABPM data from clinical trials will be a valuable resource that researchers can use to address questions about what aspects of hypertension are most associated with prognosis and which treatments affect those aspects.
authors.affiliation: Food and Drug Administration, Center for Drug Evaluation and Research, Rockville, Maryland 20857, USA.
authors.forename: R J
authors.initials: RJ
authors.lastname: Lipicky
authors.forename: N
authors.initials: N
authors.lastname: Stockbridge
mesh_terms: D000959:Antihypertensive Agents / Q000627:therapeutic use; D001794:Blood Pressure / Q000187:drug effects; D018660:Blood Pressure Monitoring, Ambulatory / Q000592:standards*; D006801:Humans; D006973:Hypertension / Q000175:diagnosis / Q000188:drug therapy
chemical_list: D000959:Antihypertensive Agents