Sensible approaches for reducing clinical trial costs.

Background: Over the past decade, annual funding for biomedical research has more than doubled while new molecular entity approvals have declined by one third.

Objective: To assess the value of practices commonly employed in the conduct of large-scale clinical trials, and to identify areas where costs could be reduced without compromising scientific validity.

Methods: In the qualitative phase of the study, an expert panel recommended potential modifications of mega-trial designs and operations in order to maximize their value (cost versus scientific benefit tradeoff).