Comparative Effectiveness of Novel Pharmacologic and Evidence-based Nonpharmacologic Treatments for Migraine Prevention - Cycle 2 2023

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• For research comparing the effectiveness of devices, must the device currently be commercially available and widely used, or is Food and Drug Administration (FDA) clearance sufficient for inclusion?
• How many LOIs am I permitted to submit to this PFA?
• Will this funding opportunity consider the comparison of novel pharmacological interventions/interventions that do not yet have established efficacy (are not evidence-based) in certain groups, such as pediatric, adolescent and/or geriatric populations?
• Is the Migraine funding opportunity only interested in CGRP comparisons?
• Will this funding opportunity accept proposals aiming to develop phone apps, instruments, etc., for the prevention of migraines?
• May I propose a pharmacological intervention that is not FDA approved, such as off-label drug use in pediatric population?
• Does PCORI consider cannabis a "novel" pharmacologic intervention?
• Are supplements and nutraceuticals "novel" pharmacological interventions?
• Are comparators aimed at preventing associated symptoms of migraines (such as recurrent gastrointestinal disturbance, benign paroxysmal vertigo, and benign paroxysmal torticollis) considered appropriate and responsive to this funding opportunity?
• What patient care (or intervention) costs may be proposed for PCORI funding support?
• When do I need to notify PCORI of the intention to request patient care costs for my proposed study?
• Are costs associated with the distribution (as opposed to the administration) of drugs and pharmacy cards considered patient care costs?
• Are costs associated with telehealth delivery of non-pharmacologic interventions (e.g., CBT) considered a patient care cost?
• Are the costs for devices (e.g., wearables) and internet hotspots needed for telehealth delivery of behavioral therapies considered a patient care cost?
• Is there a maximum budget for requested patient care costs?
• What is an example of evidence that would support the Patient Care Costs criteria of sustained uptake of study results?