By Clinical Research Staff 

September 24, 2024 | PCORI announced earlier this month that they are inviting proposals through eight new funding opportunities. These include three PCORI Funding Announcements for patient-centered comparative clinical effectiveness research (CER). Letters of intent are due October 1, 2024, and applications will be accepted until January 14, 2025.  

One of these offers includes $100 million to support CER studies promoting healthy children and youth in the U.S. Supporting youth and children’s health is one of PCORI’s Research Project Agenda Topic Themes. The grants aim to fund studies that focus on interventions that improve patient-centered outcomes among youth. PCORI is particularly interested in proposals on the following: preventing and treating pediatric obesity, addressing social determinants of health and social needs to improve health outcomes, and preventing substance abuse through identified risk factors. 

According to Tracy Y. Wang, M.D., chief officer of comparative clinical effectiveness research, children and youth make up more than 30% of the population and are the most racially and ethnically diverse age group in the U.S. They face multiple challenges to their mental and physical health. With increasing rates of depression, anxiety, obesity, and deaths due to drug misuse and injuries, it is imperative to promote health programs and treatment in this population. These interventions should focus on the care continuum, including patient and family advocacy groups, professional societies, community-based pediatric practices, payers and purchasers, and state and federal health organizations.  

PCORI is also focusing on improving the clinical trial experience for all involved. A $200 million grant is being offered through the Phased Large Awards for Comparative Clinical Effectiveness Research (PLACER) for large-scaled two-phased, randomized trials in CER that address critical decisions that patients, caregivers, clinicians, and stakeholders across the health and healthcare community undergo, which is currently lacking evidence.  

“The proposed trials should address critical decisional dilemmas that require new evidence about the comparative effectiveness of available interventions,” says Wang. “Proposed studies should compare interventions that already have robust evidence of efficacy and/or are in widespread current use.” 

The third funding opportunity being offered is available up to $160 million through the Broad Pragmatic Studies (BPS) grant for smaller-scale CER studies that include special areas on: social isolation in older adults, health communication strategies for COVID-19 vaccine uptake, and sleep health in inpatient settings. There is a particular emphasis on underrepresented groups and diverse populations for these focus areas. 

Additional smaller funding opportunities are also being offered for optimizing engagement of patients and other healthcare decision-makers in patient-centered CER design and conduct, as well as on methods development studies to enhance methodological approaches across the patient-centered CER field. These include a $36 million Science of Engagement grant that will focus on developing and maintaining active engagement with patients, caregivers, clinicians, and the general health and healthcare community throughout the research process. Wang defines engagement as “the meaningful involvement and partnership of stakeholders throughout the research process—from planning and conducting the study to ultimately disseminating study results.”  

There is also a $12 million grant that will address high-priority methodological gaps in patient-centered CER that will address improving methods of the use of AI and ML in clinical research, study design, supporting data research networks, and ethical and human subject protections issues in patient-centered CER. 

What’s in the Pipeline 

PCORI plans to issue a funding opportunity for CER on interventions for acute and/or chronic pain in December 2024. “This comes at a crucial time, as recent studies estimate more than 50 million adults in the United States are living with chronic pain conditions, with a substantial portion experiencing high-impact chronic pain that significantly limits their daily life or work activities,” says Wang. 

From pharmacological treatments to nondrug therapies, the pain-focused research funding will explore a wide breadth of pain management to explore how different approaches compare in effectiveness across diverse patient populations. PCORI is particularly interested in addressing health inequities in pain care, recognizing that underrepresented populations often face disproportionate challenges in accessing effective pain management. PCORI has four areas they are particularly focused on: urogynecological and pelvic pain; pain in individuals living with limitations in cognitive functioning; pain in individuals living with sickle cell disease; and neuropathic pain. 

PCORI also has updated their guide for engagement in research through PCORI's Foundational Expectations for Partnerships in Research. These guidelines serve as building blocks for effective and sustainable engagement with patients, communities, and other partners in research.