Late last year, PCORI introduced a new funding initiative that makes substantial investments in larger and longer comparative clinical effectiveness research (CER) projects in the form of “pragmatic studies.” These are studies designed to address important questions faced by typical patients and clinicians, so they include broader and more diverse populations than those found in traditional randomized controlled trials, where narrowly defined groups of participants are studied in highly controlled settings.
The goal is an ambitious one -- to establish a portfolio of game-changing pragmatic CER studies that will provide valuable information to patients and those who care for them, including caregivers, clinicians and system-level providers, payers and purchasers, and policymakers, as they make decisions about health and health care.
Today, we’re pleased to announce the release of a solicitation for the second cycle of funding under this initiative that will support additional large, high-impact research projects.
Our first pragmatic studies funding announcement, published last February, generated a strong response from the research community. After screening competitive Letters of Intent (LOIs), we invited 40 research teams to submit full proposals by August 8. While they prepare their submissions, we are moving ahead with launching the second funding cycle of the program.
Additional Topics of Interest
Continuous ambulatory peritoneal dialysis compared with hemodialysis (daily or intermittent home, or conventional in-center) in patients with end-stage renal disease and in important patient subgroups
Biologic agents in the management of patients with Crohn’s disease
Multi-component interventions to reduce initiation of tobacco use and promote cessation of tobacco use among high-risk populations with known disparities
Active involvement by patients and caregivers in the management of chronic mental illness
New Cycle, More Topics
The funding announcement for the second cycle adds to our previous list of 15 high-priority, high-burden topics of particular interest in this funding opportunity. The four new topics include treatment approaches for patients with end-stage renal disease and Crohn’s disease, as well as interventions to reduce tobacco use and improving management of mental illness (box).
The four new topics were developed by our Advisory Panels on Addressing Disparities; Assessment of Prevention, Diagnosis, and Treatment Options; and Improving Healthcare Systems, which met in late April to consider research topics submitted by public. The topics given top priority by the panels were further vetted by our staff to ensure that a pragmatic study is the best design to answer the research questions posed.
As in the first cycle, applicants can also choose to submit proposals for CER studies on topics identified by the Institute of Medicine (IOM), and the Agency for Healthcare Research and Quality (AHRQ), or put forth another that presents critical unanswered questions on addressing a problem that places a heavy burden on patients and families or the healthcare system. However, we will place a higher priority on topics from our published list.
What’s Next for Interested Investigators
The first step for researchers interested in applying for an award under today’s funding announcement is to submit an LOI, which is due on June 27. Before you finalize your submission, we strongly encourage you to join us by webinar for an Applicant Town Hall Session on June 4, where we will provide further details and answer questions. Our work can only be as strong as the applications we receive, so we want to help researchers develop exceptional proposals.
As a reminder, to be successful, applicants must partner with relevant national or regional patient, clinician, and other stakeholder organizations throughout the design and conduct of the study. We will be looking for strong endorsements and participation by such organizations. The involvement and enthusiasm of such groups increase the likelihood that a study’s finding will be relevant to end users and will be disseminated and implemented to change patient and clinical practices.
We hope you will consider proposing a project that can produce consequential results that will help to improve health and healthcare practices across the country.