Key result
Current phase II heart failure clinical trials often fail to correctly identify novel therapies that will succeed in phase III, highlighting the need to rethink phase II trial design.
This review highlights the limitations of current phase II heart failure clinical trials and proposes new approaches to improve the successful identification of novel therapies for phase III trials.
Phase II designs may mislead therapy advancement in heart failure; leaves open which endpoints and populations best predict phase III success.
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 have 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. In the following review, we will discuss the some of the problems inherent with current phase II heart failure clinical trials, as well as discuss possible ways to rethink phase II development of new therapies for heart failure.
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Lavine et al. (2012) conducted a review in Heart failure. Phase II clinical trial design was evaluated. Current phase II heart failure clinical trials often fail to correctly identify novel therapies that will succeed in phase III, highlighting the need to rethink phase II trial design.
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