PCORI’s work in 2014 will be defined by a significant increase in the funds we commit to our comparative clinical effectiveness research (CER) agenda, answering questions that are important to patients, their caregivers, and clinicians. Today, with our latest round of funding announcements, we take the first formal steps in making that increased investment real.
Our steady development as a national research institute—including engagement with diverse stakeholders, establishing standards for patient-centered research, and our evolving process for evaluating proposals—has positioned us to commit up to $1 billion in research funding over the next two years. Today, we are excited to announce three categories of funding opportunities that will support up to $206 million in research. Together, these eight announcements continue and refine our existing research programs and also solicit a new category of proposals that will help us expand our portfolio of studies that address the practical questions faced daily by patients and those who care for them.
New Pragmatic Clinical Studies and Large Simple Trials Initiative
The centerpiece of today’s PCORI Funding Announcements (PFAs) is our newest funding initiative, Pragmatic Clinical Studies and Large Simple Trials. This funding category was created in response to stakeholder feedback and our understanding that many important health research questions require a greater investment and longer timeline than our previously established broad funding announcements allow. As compared to randomized controlled trials, studies in the new category include broader and more diverse populations, are conducted in routine clinical care settings, are often simpler and larger, and are intended to provide information that can be directly adopted by healthcare providers.
The new initiative will accept only proposals that directly compare two or more alternatives known to be effective for a particular clinical condition. Applicants are also required to demonstrate partnerships with key patient and clinician organizations relevant to their research topic. The topics and questions we will fund are drawn from the previous recommendations of highly respected health care organizations—the Institute of Medicine’s 100 Initial Priority Topics for Comparative Effectiveness Research and the Agency for Health Care Research and Quality’s Future Research Needs Project initiative—and topics prioritized by PCORI’s own multi-stakeholder advisory panels.
We anticipate two funding cycles per year for this funding category, with each providing support for six to nine projects and awarding up to $10 million in total direct costs per study. Most funded projects will be completed within five years. Letters of Intent (LOIs) for the initial cycle are due March 7. They will be reviewed for their fit with our programmatic goals, and applicants who are invited to submit full applications will have until August 8 to respond.
We’re confident that the proposals funded under this initiative will deliver useful, high-impact findings that substantively improve our understanding of the most effective prevention, diagnosis, or treatment options for patients given their individual characteristics.
New Targeted Topics—and Our Latest Cycle of Broad PFAs
Today’s announcements will also expand our portfolio of targeted research projects, which are focused on studying specific topics identified and prioritized via input from patients and other stakeholders. Both of the subjects of our latest targeted announcements—comparative effectiveness of transitional care services and obesity treatment in primary care settings for underserved populations—present major challenges to our healthcare system.
There is little question that the healthcare community has significant room for improvement in managing the transition of patients between care settings. Patients often give poor ratings of their transitional care experiences. They and their family caregivers report that serious needs are often not met by the transition process and transitions in care bring high rates of preventable medical errors and poor outcomes.
Specifically, we’re seeking to fund research to determine which clusters of transitional care services work best for patient populations at risk in various healthcare delivery and payment contexts. We will fund one 3-year comprehensive study by an organization or a consortium of organizations that has the expertise, resources, and organizational governance needed to answer all the questions of interest. We’ve allocated up to $15 million for the total costs of this initiative.
We’re also keen to help the nation employ research to more effectively combat its growing obesity problem. More than 35 percent of adults and 17 percent of children in the United States are obese, with racial and ethnic minorities having the highest obesity rates.
We’ve allocated up to $20 million for up to two pragmatic, randomized, multi-site clinical trials to determine the real-world comparative effectiveness of obesity treatment options provided in primary care settings to underserved adults, such as members of racial/ethnic minorities, low-income individuals, and people who live in rural areas. We encourage applicants to leverage available staff, facilities, and community resources to increase the chances of healthcare providers and systems adopting promising findings.
LOIs for both the obesity and transitional care opportunities are due by March 7. Applicants will be notified on March 21 whether they have been invited to submit full applications.
Along with our new targeted opportunities, we’re also accepting applications for the Spring 2014 Cycle of broad PFAs issued under our five National Priorities for Research. In total, we’re making more than $80 million in funding available through these announcements; this includes $5 million, through our Accelerating Patient-Centered Outcomes Research and Methodological Research priority, for studies focused on the National Institutes of Health’s Patient Reported Outcomes Measurement Information System (PROMIS®). Required LOIs for these broad PFAs are due March 7 by 5:00 p.m. (ET), but any applicant who submits an LOI on time may submit a full application.
Refining Our Process
Demonstrating our commitment to being a learning research organization, all the PFAs we issued today reflect refinements in our submission process based on input we’ve received from the research and broader healthcare communities. Overall, our funding announcements now better articulate our expectations for patient-centeredness and scientific validity.
For example, we’ve added a Patient and Family Engagement Rubric, along with other resources, to provide researchers with a better sense of the patient and other stakeholder involvement that we seek in the research we support. We’ve also more strictly and clearly defined requirements related to the PCORI Methodology Standards; we hope a better-defined set of technical standards will increase the number of proposals we’ll be able to fund. Find out more about these and other improvements in this new blog post by members of our Science and Contracts Management teams.
Fulfilling Our Primary Duty
Funding high-quality comparative effectiveness research that focuses on patients’ needs and questions remains at the center of PCORI’s work. Taken together, today’s announcements will significantly increase our research investment while opening the door for new types of studies that will further serve the needs of patients and those who care for them. I encourage you to visit our Funding Center for more information.
Selby is PCORI’s Executive Director
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