Key result
Operational issues, including the enrollment of inappropriate patients with high unmodifiable event rates and reduced on-site monitoring, may contribute to the failure of phase 3 heart failure trials.
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Operational issues, such as shifting enrollment to regions with suboptimal background care and specialized recruitment centers, may contribute to the high failure rate of phase 3 heart failure trials due to unmodifiable early events.
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Cotter et al. (2018) conducted an editorial in Heart failure. Operational issues, including the enrollment of inappropriate patients with high unmodifiable event rates and reduced on-site monitoring, may contribute to the failure of phase 3 heart failure trials.
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