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(Circulation. 1999;100:e75-e81.)
© 1999 American Heart Association, Inc.

Circulation Electronic Pages

Transatlantic Conference on Clinical Trial Guidelines in Peripheral Arterial Disease

Clinical Trial Methodology

Karl-Heinz Labs, MD; John A. Dormandy, MD; Kurt A. Jaeger, MD; Claus-Steffen Stuerzebecher, MD; William R. Hiatt, MD; on Behalf of the Basel PAD Clinical Trial Methodology Group

From the Department of Angiology, University of Basel Medical School, Basel, Switzerland (K.-H.L., K.A.J.); the Department of Vascular Sciences, St George's Hospital, London, UK (J.A.D.); Schering AG, Berlin, Germany (C.-S.S.); and the University of Colorado Health Sciences Center, Section of Vascular Medicine and the Colorado Prevention Center, Denver, Colo (W.R.H.). Members of the Basel PAD Clinical Trial Methodology Group are listed in the Appendix.

Correspondence to William R. Hiatt, MD, Colorado Prevention Center, 789 Sherman St, Suite 200, Denver, CO 80203. E-mail will.hiatt{at}uchsc.edu

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.

Key Words: peripheral vascular disease • trials • drugs • guidelines