Title:Clinical Drug Development in Thromboembolic Diseases: Regulatory and Methodological Approach
VOLUME: 9 ISSUE: 2
Author(s):Gonzalo Calvo-Rojas and Antonio Gomez-Outes
Affiliation:Department of Clinical Pharmacology, Hospital Clinic, University of Barcelona, C/ Villarroel, 170, Barcelona, 08036, Spain.
Keywords:Antithrombotics, clinical trials, guidelines, methodology, thromboembolism
Abstract:Coinciding in time with the expiration of the patent of enoxaparin and clopidogrel, a number of new antithrombotics
(anticoagulants and antiplatelets with new mechanisms of action) have been developed or are still under development
for both venous and arterial thromboembolic complications. The effect of antithrombotic drugs is a continuum
where a fine tune assessment of the ischemic events that are intended to be prevented and bleeding complications derived
naturally from the own mechanism of action of the administered agent is essential. This paper discusses relevant aspects
of pivotal studies aimed to support the marketing authorisation application of new antithrombotics for the prophylaxis or
treatment of venous thromboembolism on one hand, and arterial thromboembolism on the other hand (acute coronary
syndromes and stroke and systemic embolic events in patients with atrial fibrillation). General methodological issues and
tools to assess efficacy and safety parameters and problems encountered in the way they are measured and classified are
discussed.
