Sepsis Pipeline Could Be Resuscitated With Narrower Trials, Researchers Propose

Sepsis trials designed with narrower enrollment criteria could allow treatment effects to emerge, countering the “signal to noise” problem that has plagued late-stage trials in sepsis, researchers suggest.

Sepsis has long been the Bermuda Triangle of pharma R&D, responsible for a litany of clinical failures for three decades. But researchers from UCLA and Massachusetts General Hospital East are proposing that narrowing the focus of clinical trials could allow treatment effects to become clearer -- and foster a still-nascent pipeline of new approaches to what could be a very large market for the often-fatal systemic response to infection, a common condition in critical care medicine.

Despite positive signs in preclinical and early clinical studies, demonstrating improved survival has been an insurmountable hurdle for sepsis candidates....

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