ABSTRACT
Prior to the 1990s, there were only a limited number of choices of antithrombotic agents available to the clinician. However, rapid advances in the next two decades resulted in the introduction of a plethora of agents into clinical practice, including a variety of antiplatelet, anticoagulant, and fibrinolytic agents with differing targets, modes of administration, and pharmacokinetic properties. In parallel, a number of challenges have arisen in the clinical development of such novel agents. In this chapter, I discuss the three broad themes of complexity (involving human biology, therapies, and patients), the high bar that exists for new agents owing to the prior successes, and practical drug development issues that must be addressed in the designs of modern clinical trials of novel thrombolytic and antithrombotic agents. The final section of this chapter explores some potential solutions to these challenges.
