Patient-Centered Outcomes Research Institute
Applicant Resources
Applying to PCORI? Please review information in this section if you are submitting a letter of intent, full application, or if you have already applied for funding.
About PCORI
Who Can Apply?
- Does PCORI allow for sites within the U.S. to work closely as partners with sites outside of the U.S.?
- Who is eligible to apply for PCORI funding?
- Are foreign organizations eligible for funding?
- Do you have to be partnered with an academic institution to apply?
- Does PCORI make special provisions for new or early-stage investigators? For example, does PCORI have mechanisms to support junior investigators—i.e., training and/or separate competition pool for funding?
- Does PCORI have mechanisms to support junior investigators— i.e., training and/or separate competition pool for funding?
Research We Fund
- If an applicant receives a National Institutes of Health (NIH) K Award, is he or she still qualified to receive PCORI funding?
- If an applicant proposes the establishment of a rare disease registry, would this meet requirements for PCORI funding and under which PFA would it be funded?
- Does PCORI fund research focused on developing and validating an instrument to measure behavior change?
- What populations of interest does PCORI want to address with its research?
- Is there a specific disease or condition that is a priority for PCORI?
- How does PCORI define “comparative” (placebo, usual care)? In behavioral health interventions and in prevention research, the concern is that studies comparing process variables may not meet PCORI’s definition of comparative.
Cost-Effectiveness Analysis
- What is PCORI’s official policy on cost-effectiveness analysis?
- Why does PCORI have a specific policy on cost-effectiveness analysis?
- What is the difference between cost-effectiveness analysis and cost analysis?
- Will a proposal to measure cost effectiveness as any one of the specific aims and/or to include it as any outcome of the study be deemed nonresponsive, even if it measures other outcomes that are meaningful to patients and other stakeholders?
- Will a proposal that includes a cost-effectiveness analysis as a secondary aim be deemed nonresponsive?
- Will a proposal that includes a cost-of-care analysis be deemed nonresponsive?
Engagement
- What is the difference between patients and other stakeholders?
- When proposing research focusing on prevention, who should applicants engage as patient partners?
- Should patients engaged in a proposed study have the exact condition being studied?
- Does PCORI have a requirement for the number of patients involved to qualify for meaningful involvement?
- Should patients be listed as co-investigators or consultants?
- Do stakeholders, as well as patients, have to be included in the Engagement Plan?
Letter of Intent
- How many pages is required for the Broad PFA LOI submission? Can a PI add additional information?
- Where do I find the correct LOI Template?
- What information does a Principal Investigator (PI) need to submit for the LOI portion of the application process?
- What format is preferred when using the LOI template provided by PCORI?
- How soon after I submit my LOI can I begin my application?
- How are applicants notified after a Letter of Intent (LOI) is submitted?
Using the PCORI Online System
- Are there any requirements prior to registering for PCORI Online?
- Is the PCORI contract system linked to eRA Commons?
- Whom can I contact for technical assistance when using PCORI Online?
- My PCORI Online account is locked. How do I get back in?
- PCORI Online displays that my login ID does not exist when I try to log in. What do I do?
- How do I access my LOI number?
What to Include in the Application
- How is application information submitted using PCORI Online, PCORI’s web-based application system?
- What if I plan on using a research network infrastructure (such as PCORnet) and/or related data resource (such as EMR in health care delivery systems or claims data) in my application?
- What pilot data are required in order to have a successful application? To what extent is it acceptable to propose engagement and/or designs without any prior history? Do we need to show a track record with patient or community partners?
- Are preliminary results or pilot studies required?
- If an application has 45 subcontract sites, should each PI from each site submit a Letter of Support? Are there any limits to the number of letters that should be included?
- Who should write the letters of support and to whom should they be addressed?
Budgeting
- Can patient partners serve as DSMB members?
- We would like to appoint a DSMB for our research project. Will PCORI establish a DSMB for us?
- Does PCORI require a Data and Safety Monitoring Plan (DSMP) for all of its funded research projects?
- If my project award period goes beyond 2019, will my funding be cut or rescinded by PCORI given that currently the PCOR Trust Fund must be reauthorized by Congress in 2019 to continue?
- How do I request DSMB funds for my project?
- What do I do if there is not enough room to include all of the necessary individuals in the Key Personnel section of the Budget Detail form?
Role of the Administrative Official
- Can the application be sent back to the PI if the AO identifies a problem?
- To what terms and conditions must the AO agree before approving the application?
- How is the AO notified that the submission is ready to be sent to PCORI? Does the AO log in under the PI’s ID and submit, or does he or she create a separate account?
- How do I add an AO to my application?
- Can a Principal Investigator (PI) serve as the AO?
- What are the responsibilities of the Administrative Official (AO)?
Merit Review Process
- Whom should I contact if I have questions or concerns regarding information provided in my summary statement?
- How was the scoring quartile for my application calculated?
- What information is included in my summary statement?
- When will I receive my summary statement?
- Where can I find PCORI's Merit Review criteria?
- How was the average overall score for my application calculated?
Post-Award Process
- How are award announcements made?
- When are recipients of PCORI funding able to start incurring costs for their project?
- Are there any guidelines about when a project can start?
- Can an award be transferred from one organization to another?
- Is an awardee receiving PCORI funding subject to federal audit requirements in relation to that particular PCORI award?
- How are award announcements made?
Improving Methods for Conducting Patient-Centered Outcomes Research
- Where can I find methods gaps identified by PCORI?
- How should applicants indicate how and where the Research Plan adheres to each of the Methodology Standards?
- How should applicants complete the Engagement Plan in the Research Plan if the proposals does not have robust engagement?
- What is the Methods program general policy with regard to engagement in proposals?
- Does the Methods program require applicants to complete the Engagement Template?
- What is the Methods program general policy about funding disease-specific proposals for instrument development or validation?
Pragmatic Clinical Studies to Evaluate Patient Centered Outcomes
- 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)?
- Do you have a list of patient organizations that I can use to identify the best fit for my project?
Patient-Powered Research Network (PPRN) Research Demonstration Project
Treatment of Multiple Sclerosis PFA
- May I contact someone at PCORI about the suitability of my proposed project?
- What types of costs will PCORI cover?
- What are PCORI’s guidelines for treatment cost/coverage?
- How should the proposal address patient and stakeholder engagement?
- Should I include references in my LOI?
- How will LOIs be evaluated?
Clinical Strategies for Managing and Reducing Long-Term Opioid Use for Chronic Pain
- What should I do to complete an LOI, and where can I find it?
- We have received a number of questions about the Study Advisory Committee (SAC) requirement in the targeted and pragmatic PFAs for Cycle 3 2015, and how this requirement should be managed. See below for more information.
- What do you mean by “powering the study for subgroups of interest”?
- Although Letters of Support are not required at the LOI stage, do applicants need to confirm all study sites, especially if one is choosing between a few but needs to be more time regarding visibility and buy-in?
- Medical side effects of treatment are listed as a potential key outcome. Does this mean side effects of the comparators being evaluated or does it mean side effects of opioid therapy?
- What types of observation studies PCORI would be interested in for this PFA?
Management Strategies for Treatment-Resistant Depression
- We have received a number of questions about the Study Advisory Committee (SAC) requirement in the targeted and pragmatic PFAs for Cycle 3 2015, and how this requirement should be managed. See below for more information.
- Can an organization submit more than one LOI for this PFA?
- Is PCORI interested in only the specific subgroups listed within this PFA?
- Is it a requirement that the treatment arms compare augmentation to switching?
- How is “adequate course of antidepressant treatment” defined?
- 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?
New Oral Anticoagulants (NOACs) in the Extended Treatment of Venous Thromboembolic Disease
- We have received a number of questions about the Study Advisory Committee (SAC) requirement in the targeted and pragmatic PFAs for Cycle 3 2015, and how this requirement should be managed. See below for more information.
- Can an organization submit more than one LOI for this NOACs PFA?
- 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”?
- Will an interaction test be less powerful than subgroup-specific tests? If you can demonstrate that an intervention can work in a variety of subgroups, is it required to demonstrate how those effects differ between subgroups?
- Would financial incentives to patients to increase medication adherence be an appropriate comparison intervention?