Broad Pragmatic Studies - 2023

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• What are the National Priorities for Health?
• What is the difference between the 2012 National Priorities for Research versus the 2021 National Priorities for Health?
• How do I determine to which National Priority for Health my research best aligns?
• What is the difference between PCORI’s National Priority Areas for Health, and the twelve topic themes identified within the BPS PFA?
• My proposed research does not align with one of the twelve topic themes. Can I still apply to the 2023 BPS PFA?
• How do the National Priorities for Health and Topic Themes impact my review?
• What are the differences between Categories 1, 2, and 3 in the BPS PFA?
• Are there additional requirements LOIs/Applications requesting over $5 million in direct costs?
• What are the requirements for Category 3 PCORnet® Studies?
• Can applicants to Category 1 and 2 use PCORnet®?
• If I am applying for Category 3, how should I contact the PCORnet® Front Door? How should I approach obtaining Letters of Support from PCORnet® Clinical Research Network sites?
• Must all Category 3 submissions include use of the PCORnet® Common Data Model?
• What does it mean for a study to be “multi-site"?
• What is the deferral policy for the 2023 BPS PFA?
• My Letter of Intent from the Cycle 3 2022 BPS PFA was accepted. I deferred submission of my application to Cycle 1 2023, and then to Cycle 2 2023. How will my National Priority for Health be designated?
• Will PCORI allow potential funding support of patient care costs for the BPS PFA?
• How does a request for PCORI coverage of patient care costs affect review of Letters of Intent for the 2023 BPS PFA?
• Are there any limits to the amount of patient care costs that can be proposed for coverage under the 2023 BPS PFA?
• What study intervention costs can be proposed for PCORI funding support?
• I submitted a prior BPS, Broad or Pragmatic Clinical Studies application. Would my Cycle 2 2023 submission to the BPS PFA be considered a resubmission?
• How many LOIs am I permitted to submit to the BPS PFA in each cycle?
• I have been invited to submit a full application based on my accepted LOI. Am I allowed to make any changes from the approved LOI to be reflected in my full application?
• I was invited to submit my application under Category 1 (proposed budget less than or equal to $5 million direct costs); however, our proposed budget increased in preparing our application. Can I submit my full application under Category 2?
• May I contact someone at PCORI about the suitability of my proposed project?
• 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?
• 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?
• I’m applying under the Achieve Health Equity priority area. Can I tailor and test an evidence-based intervention effective in the general population but which lacks evidence for effectiveness in populations at risk for disparities under my PCORI award?
• 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?
• What Is PCORI’s Policy for Data Management and Data Sharing and How Does It Apply to this PFA?