Pragmatic Clinical Studies to Evaluate Patient Centered Outcomes

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This content provides additional insight specific to the Pragmatic Clinical Studies PCORI Funding Announcement.

• Will the PCS PFA be issued again during Cycle 3 2021?
• Will PCORI allow potential funding support of patient care costs for future cycles of the Pragmatic Clinical Studies Funding Opportunity or for its other funding opportunities?
• How does a request for PCORI coverage of patient care costs affect review of Letters of Intent for the Cycle 1 2021 PCS PFA?
• Are there any limits to the amount of patient care costs that can be proposed for coverage under the Cycle 1 2021 PCS PFA?
• What study intervention costs can be proposed for PCORI funding support?
• I submitted a prior PCS application. Would my Cycle 1 2021 submission be considered a resubmission?
• Are there any priority topics for the Cycle 1 2021 PCS PFA?
• Do I need to submit biosketches with my LOI?
• Should I include references in my LOI?
• Do I need to include the names of all project personnel in the LOI?
• Where can I find the required LOI Template?
• What should I do to complete a Letter of Intent (LOI)?
• Where can I find the archived town hall webinars for this PCORI Funding Announcement (PFA)?
• May I contact someone at PCORI about the suitability of my proposed project?
• How do I calculate whether I am under the direct cost limit?
• How do I calculate indirect costs?
• If we establish partnerships with insurance companies, must we also partner directly with patient populations?
• Is the term “large-scale” intended to exclude rare diseases that may only have 10,000 to 20,000 patients, or does “large” relate to a significant portion of this total disease population?
• Software (mobile applications or “apps”) is being used in clinical practice. Although such software is proliferating, there is little evidence of effectiveness. Is PCORI interested in comparative effectiveness of behavior-modification apps?
• For a study comparing health system–level interventions where the primary analyses are patient-centered outcomes, can funding be used to conduct secondary analyses of economic impacts?
• What do you mean by powering the study for subgroups of interest?
• If the interventions being tested include staff or interventions not already available at the site, such as pharmacists, dietitians, health coaches, or community health workers, would the contract cover these personnel costs?
• Would financial incentives to patients to increase medication adherence be an appropriate comparison intervention?
• 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?
• If the proposed study involves populations who cannot self-report, such as children with autism, will PCORI accept outcome measures that parents and/or legal guardians have identified as important?
• Can PCORI assist with coverage with evidence development with Centers for Medicare & Medicaid Services (CMS) for large simple trials?
• If I have a design that compares the effectiveness of two alternatives, would it be acceptable to include usual care as a third arm?
• Does the proposed intervention need to be well established in the clinic before the trial, or can it be implemented at the beginning of the contract and then tested against the more traditional intervention?
• Can one comparative-treatment option be a new option for patients? For example, enhanced care based on the literature but not currently in routine practice?
• Are Veterans Affairs (VA) patients populations appropriate to study?