Broad Pragmatic Studies

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• My research includes an evidence-based intervention that has demonstrated efficacy in a general population but lacks evidence for effectiveness in populations at risk for disparities. Can I tailor/test these types of interventions under my PCORI award?
• My BPS LOI was accepted and I was invited to submit my application under Category 1 (proposed budget less than or equal to $5 million); however, our proposed budget increased in preparing our application. Can I submit my full application under Category 2?
• Why did the Broad PFA and Pragmatic Clinical Studies (PCS) PFA merge into the Broad Pragmatic Studies (BPS) PFA?
• Will the BPS PFA be reissued in future funding cycles?
• What are the differences between “Category 1” and “Category 2” in the BPS PFA?
• Are there additional requirements for Category 2 LOIs/Applications?
• What is the difference between PCORI’s National Priority Areas for Research, PCORI’s priorities named in PCORI’s 2019 authorizing legislation, and the Special Areas of Emphasis identified within the BPS PFA?
• What is the deferral policy for the BPS PFA?
• My LOI from the Cycle 3 2021 Broad PFA was accepted and I deferred to Cycle 1 2022. Will I still be eligible for a deferral into the Cycle 1 2022 BPS PFA?
• 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 Cycle 1 2022 BPS PFA?
• Are there any limits to the amount of patient care costs that can be proposed for coverage under the Cycle 1 2022 BPS PFA?
• What study intervention costs can be proposed for PCORI funding support?
• I submitted a prior Broad or PCS application. Would my Cycle 1 2022 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?
• May I contact someone at PCORI about the suitability of my proposed project?
• 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?
• 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?
• 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?
• Can my proposal call for a large simple trial “planning contract” rather than a full trial?