Large streamlined trials in cardiovascular disease

In the search for new and better therapies, reliable evidence of efficacy and safety—usually provided from large-scale randomized trials—is essential to support licensing, inform guidelines, and change clinical practice. However, the size, duration, complexity, and costs of conducting contemporary clinical trials have risen steadily. This coupled with an apparently diminishing likelihood of a positive trial has raised concerns about return on investment to the point of restricting drug development in cardiovascular diseases (CVD).1 efficient ways to conduct randomized trials need to be developed with engagement by the various stakeholders.