title: Transatlantic Conference on Clinical Trial Guidelines in Peripheral Arterial Disease: clinical trial methodology. Basel PAD Clinical Trial Methodology Group.
abstract: Guidelines for the clinical development of drugs in peripheral arterial disease (PAD) have been issued by the Food and Drug Administration for the United States and by the regulatory agency of the European Union for Europe. With increasing globalization, transatlantic cooperation in drug research and development is essential for the future and would be substantially facilitated by the existence of transatlantic guidelines. A conference was held in Basel, Switzerland, in November 1997 to discuss the scientific background of the existing guidelines on the basis of published evidence and the extensive knowledge of clinical investigators and experienced regulators. The meeting was attended by 52 invited experts from the United States and Europe, as well as by representatives from the 2 regulatory authorities. The main conclusions from the meeting are presented and may serve as a reference for the future development of transatlantic guidelines for the evaluation of pharmacotherapy in PAD.
authors.affiliation: Department of Angiology, University of Basel Medical School, Basel, Switzerland.
authors.forename: K H
authors.initials: KH
authors.lastname: Labs
authors.forename: J A
authors.initials: JA
authors.lastname: Dormandy
authors.forename: K A
authors.initials: KA
authors.lastname: Jaeger
authors.forename: C S
authors.initials: CS
authors.lastname: Stuerzebecher
authors.forename: W R
authors.initials: WR
authors.lastname: Hiatt
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods / Q000592:standards*; D017408:Guidelines as Topic; D006801:Humans; D007383:Intermittent Claudication / Q000188:drug therapy; D007511:Ischemia / Q000188:drug therapy; D018579:Patient Selection; D016491:Peripheral Vascular Diseases / Q000188:drug therapy*