Must There Be A Pharmacological Agent Proposed as a Comparator?

As of Cycle 2 2018, applicants are no longer required to propose at least one pharmacological intervention. Instead, the proposed interventions may include pharmacological treatments, nonpharmacological approaches, a combination, or complementary therapies. Interventions proposed for study must comprise the basis of symptom management decisions encountered by patients, caregivers, and clinicians. Furthermore, applicants must demonstrate sufficient evidence of efficacy or documented widespread use in the proposed population. Without documentation of widespread use, PCORI will consider studies that compare interventions without sufficient evidence of efficacy or effectiveness to be nonresponsive to this PFA.