Review of application data reveals that resubmitted applications are 30 percent more likely to be awarded funding upon resubmission. As a result, PCORI is piloting a new initiative—Fast-Track Resubmission—to expedite the application resubmission process.

This pilot will enable certain applicants to the Broad Pragmatic Studies and Methods PFAs the opportunity to revise and resubmit their application without needing to submit a new Letter of Intent, thereby enabling resubmission one cycle earlier than our traditional funding process timelines. Eligible applicants are selected at PCORI’s discretion and must meet the following criteria:

• Application scored better than 50 at the In-Person Merit Review panel meeting
• Application addresses a Special Area of Emphasis or a priority area in our research portfolio

The goal of this pilot is to identify strategies to streamline PCORI funding application pathways and ultimately increase efficiency in funding high-quality awards. For more information, please review the Fast-Track Resubmission FAQs in our Help Center.  

Historically, PCORI has not covered the costs for study interventions, including the procedures, treatments, interventions, or other standard clinical care (patient care) being proposed for comparison in the research project (patient care costs). In  2021, PCORI piloted a process in selected funding opportunities to consider funding support for applications that provided well-supported and justified requests to cover direct patient care costs. Due to early indications of the success of this pilot, the ability to request coverage of patient care costs will be available to all applicants applying to the Broad Pragmatic Studies PFA in 2022.  Additional PFAs issued during 2022 may also be included within this pilot, so please review future PCORI PFAs for additional information.

Investigators seeking coverage of patient care costs should note such requests when submitting Letters of Intent (LOI) to this PFA as indicated in the LOI template. Invited applications should describe the patient care costs, their estimated amount(s), and the evidence and justification for the necessity of their funding by addressing the criteria described within the appropriate section of the application and in the Submission Instructions.

PCORI will apply the following criteria in determining whether to consider funding support for patient care costs:

• Does the study address a strategically important comparative effectiveness question? For example, does it address a comparative effectiveness question identified by a systematic review or related to a national PCORI priority area, such as intellectual and developmental disabilities or maternal morbidity and mortality? Would study results have a potentially significant impact on clinical decision making or policy formation due to a major therapeutic advance, such as a new medical product, procedure, or care delivery innovation?
• Is there evidence that the absence of coverage of patient care costs will pose a significant barrier to adequate recruitment of participants or to the access or inclusion of key participant groups?
• Is there a high likelihood of sustained uptake of study results in the absence of future cost subsidies? Is there evidence of concrete commitments of one or more key stakeholders to support the conduct of the research project (e.g., via contribution of funding, shared resources, or in-kind support?) Have key stakeholders convincingly demonstrated their intention to support future implementation of study results through strong letters of support or other commitments to implementation of study findings through staffing, reimbursement of services, modified policies, or other actions?
• If an application is chosen for award, PCORI will evaluate these criteria in determining what patient care costs may be acceptable for potential funding consideration as part of contract and budget negotiations.

The coverage of patient care costs pilot is intended to allow applicants greater time to secure evidence of commitment from key stakeholders to support the uptake of the study results, as expressed via letters of support, supplementary funding, or contribution of other resources. Successful applications will need to justify proposed patient care costs according to criteria outlined in the PFA.  If an application is approved for award, the proposed coverage of patient care costs will be subject to review and negotiation as part of PCORI contract negotiation and execution activities. For additional information see Broad Pragmatic Studies FAQs in our Help Center.

Continuing pilot initiative from 2021 is the ability for applicants with accepted Letters of Intent to defer application submission to the next PCORI funding cycle. This pilot program is available to applicants invited to submit an application for the Broad Pragmatic Studies and Methods PFAs. Applicants may make this request up to two times, and those requests may cross cycle years (e.g., an applicant invited to submit an application for Cycle 2 may defer submission to Cycle 3, and then may potentially again request a deferral to Cycle 1 2023). Applicants may defer to the same priority area (for a BPS application) or PFA (for a Methods application).

To request a deferral, the Principal Investigator (PI) must email [email protected] prior to the application deadline, copying the institutional Administrative Official (AO). For a request to be granted, the deferral request must be submitted before the application deadline and the AO must be included in the request email. As noted above, applicants will be limited to two deferrals. Applicants will be notified of the status of their request within one business day of its receipt.

Under this pilot program, applicants will not need to re-upload their LOI or re-complete application fields for the next cycle to which they deferred within PCORI Online. Deferral requests received after the application deadline will be rejected and applicants will be encouraged to submit a new LOI for the next posted cycle.

Applicants proposing projects that fall under an SAE for a particular cycle should note that if they elect to defer their application submission to a later cycle, the SAEs might change (as stated above). However, for the Broad Pragmatic Studies PFA, any changes to SAEs would not affect application responsiveness determinations.