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Rethinking Phase II clinical trial design in heart failure

Kory J Lavine , Douglas L Mann

The incidence and economic burden of heart failure continue to rise worldwide, despite implementation of a number of effective heart failure therapies. Although there have been a number Phase I–II studies of potential novel heart failure therapies over the past decade, none of these new compounds has been successful in Phase III clinical trials. While there are likely a number of reasons for this failure, one of the problems that has become increasingly apparent is the inability of Phase II trials to correctly identify novel therapies that will be successful in Phase III clinical trials. The following review will discuss some of the problems inherent with current Phase II heart failure clinical trials, as well as possible ways to rethink Phase II development of new therapies for heart failure.