PCORI To Seek Input On Areas Of Interest For Tier 1 Research Grants
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The Patient-Centered Outcomes Research Institute’s Program Development Committee is eyeing Aug. 1 as the date it will begin the process for soliciting proposals for its “Tier 1” research grants. During the second day of the July 18-19 PCORI board of governors meeting in Washington, D.C., committee member Christine Goertz identified the research areas on which the institute will be seeking information. On Aug. 1, a 30-day comment window is expected to open to get feedback on these areas of interest. The comments will help refine the ultimate proposal requests.
Areas Of Interest For Tier 1 Grants
“We’re really interested to get projects that are focused on developing, testing and/or evaluating methods or approaches,” Goertz said. “We’re not looking at this necessarily as primary research. We are not interested in efficacy studies or comparative effectiveness studies at this point, but really projects that are able to help us to begin to evaluate some of the methods that we might use in the future for that type of research.” Five broad subject areas were identified: informing the national research priorities list; bringing together different stakeholders; translating research into practice; identifying gaps in relation to disadvantaged populations; and identifying predictors of patient outcomes. Bringing together different stakeholders has remained a constant theme since the first PCORI board of governors meeting in November 2010 (Also see "PCORI Is A “Transformative Opportunity” – Chairman Washington" - Pink Sheet, 23 May, 2011.). The board is hoping non-traditional stakeholders will make their voices heard throughout all of PCORI’s activities. It most recently began seeking public input on the definition of “patient-centered outcomes research” (Also see "PCORI Seeks Public Input On Definition Of "Patient-Centered Outcomes Research"" - Pink Sheet, 19 Jul, 2011.). Goertz, vice chancellor for research and health policy at Palmer College of Chiropractic and Palmer Center of Chiropractic Research, noted in her presentation that it is “pretty easy to have stakeholder involvement in name only. It can be much more complex that we really are looking at a broad multi-disciplinary research team that is both asking the relevant questions and then using the appropriate methods and scientific rigor to carry out the plan at hand.” NIH Tapped To Assist With Tier 1 Reviews Goertz also laid out a process for reviewing the first round of grants. The National Institutes of Health will assist in the process. The first stage of the process will involve prospective grantees submitting a letter of intent to PCORI once the funding announcement is posted. According to a timeline revealed as part of Goertz’s presentation, the funding announcement is expected to be posted in September 2011, with those letters of intent due in November 2011. While other research organizations, such as NIH, make the letter of intent an optional part of the process, Goertz said it will be a mandatory part of the coming process. PCORI staff would review the letter and share it with NIH staff. “This letter of intent would be required and really serves a couple of purposes,” Goertz explained. “It allows us to … just make sure that it does meet the areas of interest that we proposed in the PCORI funding announcement and also gives us an idea of what sort of applications we might expect so we can start to pull together lists of potential reviewers.” Goertz said the committee is anticipating “some issues with conflict of interest here in that many of the people we would like to ask to be reviewers will actually be submitting applications, so getting a head’s up about who our investigators are will be real important.” She added that by mandating the letter of intent, the board will get an idea of how many applications might be sent, which will allow the board to “fairly quickly set up the review process correctly.” Applications are expected to be due in December 2011. Goertz noted that submissions for this grant process will be paper-based. The second stage involves NIH conducting a review to ensure PCORI’s technical requirements for the applications are met, including aspects such as page length, fonts and other aspects. “We’re asking NIH to help us review the applications to make sure they meet our technical requirements,” Goertz said. “This also provides an opportunity for scientists at NIH – scientific review officers or SROs – to really look at the scientific content and really to begin to help us start thinking about what types of scientific and stakeholder expertise might be required. That process will feed into the process that PCORI has already started with the letter of intent.” Concurrent with stage two is the third stage, during which PCORI staff will be reviewing the applications to see if the programmatic areas of interest are met. “We’ve already done a little bit of that with our letters of intent, but [the stage three review] will be done at a more intensive level after the actual applications are received,” Goertz said. The actual review process will be considered the fourth stage of this process, and it is expected to occur in January and February of 2012. NIH will be handling the review. “We envision there will be a number of review committees that are set up, depending on the types of applications we get,” Goertz said, emphasizing that the PCORI board of governors will have final say on the scientists and stakeholders that will serve on the review committees. Reviewers will conduct a thorough review of the applications. The submissions will be scored and then forwarded to PCORI staff.
Tier 1 Grant Proposed Timeline
In March 2012, the fifth stage – PCORI’s review of the applications – will occur. The board “will conduct a meeting to review the summary statements and all other information pertinent [to] the applications and then make a final funding decision based on a number of criteria – the perceived significance, the quality of the science and then finally the programmatic needs of PCORI,” Goertz explained. Stage six involves PCORI doing a final review “for fiscal compliance with the PCORI grant policies and procedures, making sure that the appropriate [institutional review board] approvals and processes are in place, that budget requirements have been met, that they are addressing intellectual property and data use issues” that will be covered by the grants policies and procedures. Grants are expected to be awarded in April 2012. Goertz said there will be an additional review of the grantees’ work after the first year of funding “to ensure that aims are being met and that the work is progressing as was intended.” Concerns On Meeting Outreach Objectives Concern was expressed regarding how the grant process would effectively reach out to the non-traditional stakeholders PCORI is trying to make a part of its processes, which has been among the objectives of these and other research opportunities set by the board (Also see "Patient Engagement A Key Part Of PCORI’s “Tier 1” Grants" - Pink Sheet, 23 May, 2011.). “The deck is going to be stacked for those who know how to do research,” board member Grayson Norquist, chairman of the Department of Psychiatry and Human Behavior at the University of Mississippi Medical Center, said. He suggested that the funding announcement could be used as a tool to bring in some of the non-traditional stakeholders. “I think we need to think about how we could ensure or give some added weight to certain groups … because I am really concerned that two [or] two-and-a-half months is a quick time” for people not normally engaged in this kind of research. Goertz said the committee is working on ways to reach out to as wide a group as possible for the grant funding announcement process. Board member Allen Douma, CEO of Empower LLC and AARP board member, also noted that there could be challenges bringing in patients to the review process. “We need to ask ourselves, ‘Are we going to have a patient on every review committee?’ If so, that’s a lot of patients, but we’ve got to start gathering them now,” Douma said. Board member Freda Lewis-Hall, chief medical officer at Pfizer, agreed that it is important to have a unique set of reviewers, but they also need to be experienced. “The question is whether or not we’ve given any thought to what those unique reviewers look like and where they might come from other than the usual scientific environment that we’re used to for review.” Goertz noted that AHRQ “has been training diverse types of stakeholders to be reviewers, so that would be one source.” She solicited the board for any ideas to bring in more non-traditional reviewers. “Right now, to a certain extent, we are doing it a little bit in a vacuum because we don’t know what types of applications we are going to get,” Goertz continued. “We need to be as proactive as we can right now about identifying potential groups that can help us in identifying reviewers and then be ready to really hit the ground running. Once we get the applications themselves, we [will] know exactly what types of expertise we will need.” Another issue that was raised was in regard to board member participation during the peer review stage. Methodology Committee member Sharon-Lise Normand, professor of health care policy at Harvard Medical School, said board members “should only be listeners at any peer review committee meeting. I don’t think they should talk to the SRO. I think that’s undue influence.” |