Round One: PCORI Gets Into the Business of Funding Patient-Centered CER

PCORI marked a major milestone this week in our drive to build a portfolio of research that will provide patients and those who care for them with the information they need to make better-informed health and healthcare decisions.

Our Board of Governors approved our first round of primary patient-centered comparative clinical effectiveness research, 25 projects, totaling $40.7 million, for proposals that address the first four areas of our National Priorities for Research and Research Agenda. All were approved pending a business and programmatic review by PCORI staff and completion of a formal award contract.

In approving these projects, our selection committee, made up of PCORI Board, Methodology Committee and staff members, sent a strong message in deciding to fund only those projects that were clearly centered on patients’ interests, hold the promise of improving practice, and include patients and other stakeholders relevant to the study question as integral parts of the research team.

This approach is true to both the charge we were given by Congress and the input we’ve received from the broad healthcare community -- that patients and other key stakeholders should be active and meaningful partners in research, not simply subjects. It is a critical step in meeting our commitment to “research done differently.”

How did we do it? Each of the nearly 500 proposals we received earlier this year went through a competitive, two-stage review process that incorporated scientists, patients, caregivers and other stakeholders in the evaluation of proposals.

Applications were evaluated on scientific and technical merit, engagement of patients and other stakeholders, methodological rigor, and fit within our research priorities and research agenda.

Our selection committee was blinded to anything but reviewers’ scores. So we’re especially pleased at the result – a set of innovative and high-quality projects, based at institutions in 17 states, all with designated sets of patients and other stakeholders as partners, addressing a balance of major conditions, populations, geography, and well distributed across our first four national research priority areas.

The projects approved include studies of how to improve care for people with such health problems as bacterial and viral infections, cardiovascular disease and stroke, certain cancers, chronic kidney disease, depression and other serious mental illness, and pediatric diabetes, as well cross-cutting proposals investigating chronic pain and how to improve care for people with multiple conditions. Other projects seek ways to improve patient-clinician communication, reduce selected health disparities, and improve the way healthcare systems operate.

Each is distinguished by its focus on:

• Patient-Centeredness -- Is the proposed research focused on questions and outcomes of specific interest to patients and their caregivers?
• Innovation & Potential for Improvement – Might the proposed research lead to meaningful improvement in patient health and is the approach novel or innovative in ways that make it likely to change practice?
• Team & Environment – Do the researchers have appropriate experience and have they included in their team the relevant patients and other key healthcare community members, who are the focus of the study and would use its information?

All proposals approved by the Board still must clear a business and programmatic review by PCORI staff and complete a formal award contract.

As a long-time researcher myself, I know our applicants worked diligently to submit proposals that they hoped would be funded, and that many are disappointed at not being selected in this initial round. We know our patient-centered approach to proposals is new to many within the research community. Changing the way research is conducted is a challenging process that takes time. So we hope those not funded this time will revise and resubmit their proposals based on reviewers’ comments.

But we certainly appreciate that the number of proposals approved in this initial round was modest, especially given what we’d initially expected to support with the available funding. We hope this was a first-time phenomenon. However, as a learning organization, with new and evolving processes, we take this first-round experience as an opportunity to assess our approach and, with ongoing community input, determine how we might do a better job with our application guidelines and review process in the future. We already have several thoughts about that.

For example, We’re looking at adjusting our review protocol so that there will be only one round of review in the future – still rigorous, still patient-centered, but streamlined. We plan to revise our application guidelines in response to community input to make them more useful. And we’re committed to working with the research community – including seasoned professionals, new investigators, and the stakeholders with whom they will partner – to help everyone better understand our programmatic goals and our unique funding criteria. So look for specific ideas in the areas of outreach, education and training in coming months.

As is our style, we’ll share what we learn over time with the research, patient, caregiver and other stakeholder communities, so they can learn right along with us and help us to continually improve.

We eagerly await the start of our first round of projects. Their success will be measured by whether they produce meaningful, trusted information that patients, caregivers, clinicians and others can easily and effectively use to improve healthcare decision making and, ultimately, patient outcomes. I want to personally thank everyone who has been involved in the process so far, especially our multidisciplinary teams of reviewers and the research teams that submitted proposals.

You can join them. If you have not registered yet to be a PCORI reviewer, you can learn more and sign up through our website. You also can learn about upcoming deadlines for submitting research proposals by visiting the Application Center for our primary research funding announcements.

We have big plans for future funding, expecting to commit to nearly $355 million in research contracts in 2013. That will include Cycles II and III of funding announcements under our first four priority areas, an expected two of three planned cycles under our fifth priority, and at least initial funding for the topic-specific funding announcements we expect to start issuing in early 2013.

Thank you again for your support and participation in our work as we strive to produce better information for patients and those who care for them.