Phased Large Awards for Comparative Effectiveness Research (PLACER) FAQs

PLACER Requirements and Specifications

Is a feasibility phase required for PLACER awards?

The two phases of PLACER funding are intended to allow the uninterrupted conduct of a large and challenging clinical trial after testing its acceptability to participants and overall research operations and infrastructure. An independent feasibility study done elsewhere will not adequately satisfy these testing needs.

PCORI expects projects submitted to the PLACER PCORI Funding Announcement (PFA) to be of significant scale, scope and complexity and thus require support of an initial feasibility phase for study refinement, feasibility testing, stakeholder engagement and infrastructure establishment. Continued funding of the second phase to carry out the full-scale trial will be contingent upon the achievement of specific milestones and deliverables in the feasibility phase. PCORI has not set a minimum duration for the feasibility phase. Applicants are advised to propose a well-justified plan and duration for their feasibility phase that will maximize the likelihood that the full-scale trial will achieve its aims in an efficient and timely way. Applicants should propose specific milestones and deliverables to be achieved in the feasibility phase. If an award is made, final milestones will be negotiated in conjunction with PCORI and used in the evaluation of whether the full-scale study may continue with PCORI support. For more information and examples of appropriate activities to include in feasibility phase, please review the PLACER PFA.

Will there be an evaluation and decision after the 18-month feasibility phase? What will that evaluation comprise? What is the process? What are the criteria for determining feasibility? Will it work like it does in the NIH Collaboratory?

The PLACER PFA indicates that all projects will undergo an evaluation based on review of prearranged, study-specific milestones and progress in combination with an assessment of the full-scale trial’s feasibility and likelihood of achieving its aims. This evaluation will be initiated several months after the study begins and be completed no later than 18 months after study start. If the review is favorable, the contract will be modified to continue funding support for the full-scale trial without a need for resubmission or recompetition.

Under one PLACER award, are multiple randomized controlled trials (RCTs) allowed, similar to the program project/center grants used by the National Institutes of Health (NIH) to establish large, multi-project efforts including a diverse array of research studies?

The PLACER PFA is intended to support the conduct of a single large RCT, not multiple RCTs under one awarded contract. The PLACER PFA is not intended to be a program or center grant mechanism.

What types of study designs are acceptable under the PLACER PFA?

Applications must propose research projects with primary outcome(s) based upon a randomized trial design using either individual or cluster randomization as appropriate to the study design. Study designs using solely observational data will not be considered responsive.

What is the difference between an existing intervention and an emerging innovation? What level of efficacy data is needed to be responsive to the PLACER PFA?

PCORI distinguishes existing interventions as having indisputable evidence of efficacy or widespread use; emerging innovations have limited evidence of efficacy or use in clinical care and have significant residual uncertainty compared with existing interventions. Considering the significant effort, time and PCORI funding entailed in PLACER awards, applications should focus on the comparison of existing interventions as defined previously. Evaluations of emerging innovations have the potential to be addressed with other funding opportunities such as the Broad Pragmatic Studies PFA that is offered concurrently with PLACER.

The PLACER PFA requires the use of randomized clinical trial designs and clear evidence of the well-established efficacy and current use of the proposed interventions in multiple settings. If efficacy is not well established, then widespread use must be well documented. The initial feasibility phase of research is neither to develop an intervention nor to test its efficacy or anticipated effect size.

PLACER Principal Investigators and Structure

How many co-principal investigators (PIs) are acceptable? Could there be three, including two co-PIs who are running the clinical trial plus one co-PI who represents the Data Coordinating Center (DCC)? 

It is PCORI policy across all research award mechanisms that no more than two PIs (dual-PIs) can be named on an application. When proposing an application with dual-PIs, you must designate one individual as the contact PI. The contact PI is responsible for submitting the application and will serve as PCORI’s primary point of contact for all communication. PCORI asks that you rely on the Leadership Plan Template (embedded within the Research Plan Template) to describe the significance of each individual’s role on the leadership team (dual PIs and co-PIs) to capture the scope of their responsibilities in decision making, management and advisory consultation.   

For the PLACER PFA, PCORI requires that the PI of the DCC and the PI of the Clinical Coordinating Center (CCC) be named and serve as dual-PIs to promote parity, scientific independence and autonomy of clinical, data management and analytical input into study decisions. If other arrangements are proposed, applicants must seek prior approval from PCORI to ensure the coequal and independent voices of the CCC and DCC in trial design, conduct and oversight. Please use relevant sections of the research plan template to demonstrate DCC parity, scientific independence, and autonomy in study decisions.

Could you provide more information as to the role of the DCC? Does this need to be an existing standalone center that already performs the required functions? 

PCORI requires applicants to include a DCC with an independent scientific leadership role in study decision making about the analytical, statistical and data management aspects of both study phases for this PFA. For potential applicants to this PFA, an LOI may be submitted without a DCC being in place—with the proviso that invited applicants include a DCC as part of their application submission. The DCC is expected to make a substantive contribution to refining the final trial design and protocol, data collection and management, and the statistical analysis plan. During the full-scale study phase, the DCC is expected to manage data reporting; monitor study enrollment and retention; assure data quality and completeness; prepare reports for the Data Safety and Monitoring Board (DSMB); carry out all necessary statistical analyses of study findings; and ensure a high level of data integrity, security and protection. The requirements described above provide the best guidance about acceptable DCC configurations.

Can a stakeholder serve as a dual-PI for awards under the PLACER PFA? 

Given the size, complexity and anticipated risks of the research sought by PCORI under PLACER, PCORI requires that the PI of the DCC and the PI of the Clinical Coordinating Center (CCC be named and serve as dual-PIs to promote parity, scientific independence and autonomy of clinical, data management and analytical input into study decisions. If other arrangements are proposed, applicants must seek prior approval from PCORI to ensure the coequal and independent voices of the CCC and DCC in trial design, conduct and oversight.   

Stakeholders can make significant contributions in PLACER trials by serving as coinvestigators or in other leadership roles within the governance or management structure of the study.

I am an early career researcher. Am I eligible to apply? 

In general, PCORI expects applicants to assemble a research team that is well-qualified and suited to complete the work proposed. Applications must demonstrate that the study team’s experience, leadership approach, governance and organizational structure are appropriate for the project and will aid in achieving the project goals. The PLACER PFA is one of PCORI’s largest funding opportunities and intended to support large and complex multisite trials that are anticipated to be demanding and present some degree of risk to achieve their study aims. PCORI’s funding decisions support research where the PI and leadership team have an aggregate level of expertise and experience that is commensurate with the scope and complexity of the proposed research. We encourage you to review the PLACER funding announcement, submission instructions and eligibility information posted to PCORI’s website and discuss the advisability of your research proposal with your sponsored research office and others at your institution.

What qualifies as "experienced" leadership in stakeholder engagement? Can you give examples of individuals whose experience made them well-suited versus not well-suited for this role? 

Experienced leadership in stakeholder engagement could be demonstrated by previously leading or managing engagement within a PCORI research award or leadership within a PCORI engagement award. Individuals or organizations with experience identifying stakeholder partners, preparing stakeholders and research study staff to engage, structuring meetings and alternative methods for soliciting input, driving the uptake of stakeholder feedback, and monitoring engagement would be strong additions to PLACER study team leadership. Individuals or entities that have a history working within a specific community and are considered trusted brokers and conveners of key stakeholders offer certain advantages, as could individuals or entities that have more general knowledge coupled with extensive experience in managing stakeholder engagement. Additional qualifications include skills in negotiation across a diverse set of working relationships, translation of the ideas and values of stakeholder groups, and project management.

PCORnet^®

Is the use of PCORnet® required for the PLACER PFA? 

The use of PCORnet^®, the National Patient-Centered Clinical Research Network, is not required. Applicants proposing to use an existing research network infrastructure (e.g., PCORnet), research consortia, or related data resources (e.g., electronic medical records data from healthcare delivery systems or administrative claims data from public or commercial insurers) should address this with sufficient specificity in the Research Plan, as appropriate. Applicants should also refer to the PCORI Methodology Standards for Data Networks as Research-Facilitating Structures.

If I am interested in using PCORnet as part of my study, how do I get started? 

Visit https://pcornet.org/contact-us/ to contact PCORnet through its Front Door and a member of the team will contact you to discuss your ideas. 

PCORI’S National Priorities for Health and Topic Themes

Should my study align with PCORI’s National Priorities for Health?  

This funding opportunity seeks applications addressing three of PCORI’s National Priorities for Health. To be considered responsive, applications must propose research meeting the distinctive requirements of this PFA addressing at least one of the following National Priorities for Health:  

• Increase Evidence for Existing Interventions and Emerging Innovations in Health
  • Goal: Strengthen and expand ongoing comparative clinical effectiveness research focused on both existing interventions and emerging innovations to improve healthcare practice, health outcomes and health equity.
• Accelerate Progress Toward an Integrated Learning Health System
  • Goal: Foster actionable, timely, place-based and transformative improvements in patient-centered experiences, care provision, and ultimately improved health outcomes through collaborative, multisectoral research to support a health system that understands and serves the needs and preferences of individuals.
• Achieve Health Equity
  • Goal: Expand stakeholder engagement, research and dissemination approaches that lead to continued progress toward achieving health equity in the United States.

Applicants will be asked to select one of the three National Priorities above as primary, and if relevant, a secondary and/or tertiary National Priority in their LOIs and, if invited, full application.  

For questions about the suitability of specific research topics, please direct inquires to [email protected]

How do I determine to which National Priority for Health my research best aligns?  

The primary aim or research question will typically guide the designation of the application’s primary National Priority for Health.    

Applications are allowed to optimize and synergize multiple priorities in their proposed research.  If multiple priorities are addressed in an application, applicants should designate their relative priority for PCORI to use in guiding LOI and application review.   

What is the difference between PCORI’s National Priorities for Health and the 12 Topic Themes identified within the PLACER PFA? 

The PLACER PFA seeks applications that address three of PCORI’s five National Priorities for Health. To be considered responsive, applications must describe research that compares at least two alternative approaches to achieve one or more of the National Priorities for Health. Applicants will be asked to select a primary National Priority, and, if relevant, a secondary and/or tertiary National Priority in their LOI, and if invited, in their full application.

PCORI has a total of 12 Topic Themes of interest that will inform PCORI’s funding opportunities over the next several cycles. Consideration of these themes is welcome but not required.  Within LOIs and applications, applicants will be asked to designate the primary, and as applicable, secondary and/or tertiary Topic Theme(s) with which their proposed research most closely aligns. Applicants may also select “other” if their research does not align with any listed theme.  Additional information about the Topic Themes and example projects is available on the PCORI website.

As mentioned above, submissions are not limited to these Topic Themes; however, all PLACER applications must select one of the three PCORI National Priorities for Health identified in the PFA.

General PCORI Application Questions

I have questions about the suitability of my research project for this PFA. May I speak with a PCORI staff person? 

Yes. In an effort to better triage your request, please submit a one to two paragraph description of your research question to [email protected]. Please highlight the research question, aims, condition and population, intervention/comparators, and outcomes. Do not submit a draft LOI because these cannot be pre-reviewed by PCORI. Please feel free to list inquiries for us to address.

Where can I find the slides from the Applicant Town Hall for the PLACER PFA? 

The presentation slides and a recording of the webinar are located here.

What if some projected research costs for my PLACER submission are not covered by PCORI or they exceed the PLACER funding cap? 

Research institutions may seek funding from other sources for intervention or other research costs that cannot be covered under a PCORI PLACER award. Such additional funding, however, must be secured by the investigator independently of PCORI before a final PCORI award decision is made. PCORI does not assist individual investigators in identifying and developing potential additional funding sources related to a competitive open PCORI funding opportunity. 

If an applicant expects to require funding in addition to the PCORI award to complete the proposed research within PCORI’s funding cap and associated requirements, such support does not need to be in place at the time of Letter of Intent (LOI) or application submission. However, the need for additional funding must be identified in the application and be in place before PCORI finalizes the award. A potential applicant’s pursuit of additional outside funding is the sole responsibility of the applicant. If a proposed research project requiring additional funding has successfully proceeded through PCORI’s selection processes, before finalization of the award, PCORI will discuss with the applicant the specifics and status of their efforts to obtain additional funding. 

What is the permitted page length for an LOI? 

An LOI for this funding solicitation should be no longer than four pages. 

Are patients from other countries allowed to participate in studies funded through this announcement? 

PCORI seeks research findings that are applicable and meaningful to the US population, its care choices, and the systems and conditions under which US healthcare is delivered. If an applicant wishes to include foreign patients as part of their trial, the relevance and representativeness of their inclusion, experience and outcomes should be well-justified and defensible. 

May investigators build upon a current or prior PCORI-funded study or its findings? 

The PFA requires applications in comparative clinical effectiveness research that are based upon a documented evidence gap and which provide established evidence of intervention(s) efficacy or widespread use. Applications may be submitted if they build upon ongoing or prior PCORI-funded studies which meet these requirements.

What is the deferral policy for PLACER?

PCORI will pilot the application submission deferral process for the PLACER PFA. Deferrals are available to applicants who submitted an LOI to the PLACER PFA and are invited to submit a full application. Applicants will be limited to two sequential deferrals, which may cross funding cycle years (e.g., an applicant who is invited to submit a full application for Cycle 2 2023 may defer submission to Cycle 3 2023 and then may potentially again request a deferral to Cycle 1 2024).

To request a deferral, the 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.

Within each cycle of the PLACER PFA, applicants are permitted to submit multiple LOIs, provided they are scientifically distinct.  If an applicant has deferred an application submission to a given cycle, they may NOT submit another LOI with significant scientific overlap to the deferred application within that cycle.

Under this pilot program, applicants will not need to reupload their LOI or recomplete 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.

What is PCORI’s Policy for Data Management and Data Sharing and how does it apply to this PFA?

Fundamentally, the Policy articulates PCORI’s expectation that awardees make the data from their PCORI-funded research projects available to third-party requestors. Importantly, it provides funding to our awardees for their time and effort in preparing the data to be shared. The Policy includes details about what data certain awardees will be expected to deposit into a designated data repository and when that data would be available for third-party requests. It describes the data request process, the criteria used to assess the scientific merit of the requests and the independent committee that will review data requests. · Please refer to the Policy web page, data sharing FAQs and the PFA for more information on PCORI’s Policy for Data Management and Data Sharing.

For awards made under the PLACER funding mechanism, awardees will only be required to deposit the Full Data Package if the study proceeds to the full-scale study phase. Studies transitioning successfully to the full-scale study phase will have the data-sharing milestones added to the full-scale study phase milestone schedule as part of the negotiation of the contract modification. The Full-Scale Study Phase Data Safety and Monitoring Plan should ensure compatibility with PCORI’s Policy for Data Management and Data Sharing with respect to institutional policies and informed consent language.

Posted: September 1, 2023