Transatlantic conference on clinical trial guidelines in peripheral arterial disease - Clinical trial methodology

Guidelines for the clinical development of drugs in peripheral arterial dis ease (PAD) have been issued by the Food and Drug Administration for the Uni ted States and by the regulatory agency of the European Union for Europe. W ith increasing globalization, transatlantic cooperation in drug research an d development is essential for the future and would be substantially facili tated by the existence of transatlantic guidelines. A conference was held i n Basel, Switzerland, in November 1997 to discuss the scientific background of the existing guidelines on the basis of published evidence and the exte nsive knowledge of clinical investigators and experienced regulators. The m eeting 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 fo r the future development of transatlantic guidelines for the evaluation of pharmacotherapy in PAD.