How Does PCORI Assess and Select Topics for Potential Research Funding?

In selecting topics for PCORI Funding Announcements (PFAs), our goal is to identify research questions that matter to patients, caregivers, clinicians, and other healthcare stakeholders but have not been answered reliably by previous studies. Research topics are suggested through multiple sources, including healthcare stakeholders and PCORI’s Board of Governors, staff, and Advisory Panel members. Some of these topics are submitted through our website

A topic may be deemed ineligible or discarded if research in that area is already under way, the topic doesn’t align with our research strategy, or it doesn’t meet established criteria.

Where Topics Are in Our Prioritization Process
List 1: Nominated Topics List 2: Approved for Topic Brief Development
List 3: Approved for Advisory Panel Review List 4: Reviewed by Advisory Panels
List 5: Approved for Refinement List 6: Approved for a Targeted Funding Announcement
List 7: Listed as a PCORI Priority in a Pragmatic Clinical Studies Funding Announcement

We employ the following process to evaluate and approve research topics and prepare PFAs. We work with stakeholders throughout this process to refine the questions so that they can be effective as the basis for comparative clinical effectiveness research (CER). As such, questions on lists 1–5 should be viewed as preliminary.

Topic Generation All Horizontal

Step 1: Determine Eligibility of Topics

Topics are screened for basic eligibility by PCORI staff using Tier 1 review criteria. Next, eligible topics are screened and prioritized by other PCORI staff and topic experts using Tier 2 review criteria. CER questions are developed for the topics, as needed.

Step 2: Review of Topics

PCORI’s Science Oversight Committee (SOC) reviews the selections to determine whether the questions fit our research strategy and are ready for consideration by our multi-stakeholder advisory panels.

Step 3: Preparation and Review of Topic Briefs

Topic briefs are prepared summarizing previous research, pointing out gaps in evidence, and recommending appropriate CER questions. The SOC reviews the briefs and approves the questions.

Step 4: Prioritization

The appropriate PCORI Advisory Panels prioritize the CER questions according to Tier 3 review criteria.

Step 5: CER Question Refinement

The SOC reviews the prioritized CER questions and decides whether they should proceed to workgroups for further development. Questions that are not selected remain on list 4.

PCORI staff assemble workgroups made up of topic experts and healthcare stakeholders, including patients, caregivers, clinicians, and researchers, that recommend refinements of the CER questions.

Step 6: Assign CER Questions and Seek Board Approval for Targeted Announcements

Staff and the SOC use Tier 4 review criteria to review the questions recommended by the workgroup. The committee then assigns the questions for development as a targeted PFA (LIST 6) and/or for the suggested topic list in pragmatic clinical studies PFAs (LIST 7). Questions that are not assigned top priority at this step may be reconsidered by the SOC and advisory panels in future rounds of review.

Questions recommended for targeted PFAs are reviewed by the Board, which votes on approval. PCORI staff then develop approved questions into funding announcements.

Tier 1-4 Review Criteria

Tier 1

Reviewed by PCORI staff:

  • Is this a comparative effectiveness research question?
    • Are two or more options (one of which can be usual care) being compared? - eligible
    • Or is it instead a comment, a descriptive question, or a question of disease causation or biological mechanism – ineligible
  • Is this question duplicative with another question already in the research topic database? - ineligible
  • Is the question patient-centered: i.e., is the comparison relevant to patients, their caregivers, clinicians or other key stakeholders and are the outcomes relevant to patients? - eligible
Tier 2

Reviewed by PCORI staff and topic experts:

  • Impact of the condition on the health of individuals and populations
  • Important evidence gap is believed to exist (e.g. by virtue of a recent, credible evidence synthesis)
  • Is PCORI-funded research likely to close this evidence gap?
  • Likelihood of implementation of relevant findings into practice. (e.g., do one or more major stakeholder groups endorse the question).
Tier 3

Reviewed by Science Oversight Committee and Advisory Panel:

  • Patient-Centeredness: is the comparison relevant to patients, their caregivers, clinicians or other key stakeholders and are the outcomes relevant to patients?
  • Impact of the Condition on the Health of Individuals and Populations: Is the condition or disease associated with a significant burden in the US population, in terms of disease prevalence, costs to society, loss of productivity or individual suffering?
  • Assessment of Current Options: Does the topic reflect an important evidence gap related to current options that is not being addressed by ongoing research.
  • Likelihood of Implementation in Practice: Would new information generated by research be likely to have an impact in practice? (E.g. do one or more major stakeholder groups endorse the question?)
  • Durability of Information: Would new information on this topic remain current for several years, or would it be rendered obsolete quickly by new technologies or subsequent studies?
Tier 4

Reviewed by Science Oversight Committee and Advisory Panel:

  • A specific question (comparison) has been identified about prevention, diagnostic, treatment options or system-level interventions that are currently covered in at least some settings.
  • The importance of the topic as determined by high scores from the advisory panel, strong interest from one or preferably more than one key stakeholder groups, and strong assessment of potential to change practice, warrants set aside funding and closer involvement in the study by PCORI.
  • May require higher level of funding than the usual pragmatic clinical study – either for larger sample size, longer follow-up or more complex interventions/data collection needed to pursue the specific question.

Posted: July 31, 2014; Updated: May 4, 2015

What's Happening at PCORI?

The Patient-Centered Outcomes Research Institute sends weekly emails about opportunities to apply for funding, newly funded research studies and engagement projects, results of our funded research, webinars, and other new information posted on our site.

Subscribe to PCORI Emails


Hand pointing to email icon