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Past Opportunities to Provide Input
- PCORI's Proposed Research Agenda (2021-2022)
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- Proposed Principles for the Consideration of the Full Range of Outcomes Data in PCORI-Funded Research (2020)
- Proposed New PCORI Methodology Standards (2018)
- Data Access and Data Sharing Policy: Public Comment (2017)
- Proposed New PCORI Methodology Standards (2017)
Comment on the Proposed New and Revised PCORI Methodology Standards (2016)
- 1. Standards for Formulating Research Questions
- 10: Standards for Studies of Diagnostic Tests
- 12. Standards on Research Designs Using Clusters
- 13: General Comments on the Proposed Revisions to the PCORI Methodology Standards
- 2: Standards Associated with Patient-Centeredness
- 3: Standards for Data Integrity and Rigorous Analysis
- 4: Standards for Preventing and Handling Missing Data
- 5: Standards for Heterogeneity of Treatment Effects
- 6: Standards for Data Registries
- 7: Standards for Data Networks as Research-Facilitating Structures
- 8. Standards for Causal Inference Methods
- 9. Standards for Adaptive Trial Designs
- Peer-Review Process Comments (2014)
- Draft Methodology Report Public Comment Period (2012)
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WASHINGTON, DC — The Patient-Centered Outcomes Research Institute (PCORI) today began inviting proposals for new studies and implementation projects through nine funding opportunities. These PCORI Funding Announcements (PFAs) include up to $467 million for comparative clinical effectiveness research (CER) studies that help determine which health care approaches work best for patients and their caregivers given their particular circumstances.
One PFA calls for large, two-phase CER studies designed to fill critical evidence gaps. Three PFAs focus on specific, high-burden topics identified by the healthcare community: improving management of multiple chronic conditions, optimizing healthy aging, and preventing osteoporotic fractures. Another PFA calls for CER proposals within four broad PCORI research priority areas: addressing disparities; assessment of prevention, diagnosis and treatment options; communication and dissemination of research; and improving health care systems.
The remaining funding announcements seek proposals for projects to implement results of PCORI-funded research and to improve methods of patient-centered CER.
"With these latest funding opportunities, PCORI proudly continues its essential role as the nation’s leading funder of patient-centered, comparative clinical effectiveness research," said Nakela L. Cook, M.D., M.P.H. "The research funded through these opportunities will provide sound evidence to help patients, their clinicians and caregivers make sense of their many options in a complex healthcare environment. This research also will help to generate data and strategies that help reduce persistent health disparities, an important step toward achieving health equity, one of PCORI’s National Priorities for Health."
Two CER funding opportunities together offer up to $362 million
The largest funding announcement, the Phased Large Awards for Comparative Effectiveness Research (PLACER) PFA, seeks proposals for large, two-phase randomized controlled trials with up to $22 million in direct costs per study. Proposed trials should address established and important decisional dilemmas that require new evidence about the comparative effectiveness of available interventions. PCORI welcomes submissions in all areas and encourages proposals focused on reducing maternal mortality and improving care for individuals with intellectual and/or developmental disabilities. PCORI offers up to $200 million total through this PFA.
The Broad Pragmatic Studies PFA seeks proposals for CER studies lasting up to five years falling into two categories of scope. One category allows direct costs up to $5 million and the other direct costs up to $10 million. PCORI encourages submissions in all areas and notes the following special areas of emphasis: addressing racism, discrimination and bias in health care organizations and integrated care delivery systems; caregiver-delivered interventions for intellectual and developmental disabilities; optimizing prevention and treatment of postpartum hemorrhage; and visual impairment in older adults. PCORI offers up to $162 million total through this PFA.
Three targeted CER funding opportunities together offer up to $105 million on specific topics
One targeted PFA seeks proposals for research that will compare different approaches to incorporating access to and use of telehealth in primary care to improve outcomes among individuals with multiple chronic conditions. Studies proposed should be designed to detect outcomes specific to one or more vulnerable populations. PCORI offers up to $50 million through this PFA, providing up to $5 million in direct costs for one study category and another study category with direct costs up to $10 million per study.
Another targeted PFA focused on healthy aging offers up to $25 million total for CER on interventions that aim to achieve one or more of the following four goals: maintaining function and independence, facilitating chronic disease management, supporting individuals with significant functional impairment, and reducing caregiving burden and improving quality of life. PCORI will provide up to $5 million in direct costs per study.
A third targeted PFA seeks proposals for studies that will compare the effectiveness of pharmacological and/or nonpharmacological combination interventions in preventing bone fractures and improving outcomes among people with osteoporosis and a history of fractures. PCORI offers up to $30 million total through this PFA, providing up to $10 million in direct costs per study.
Consideration of full range of outcomes data in PCORI-funded research
PCORI encourages investigators who respond to these latest funding opportunities to identify and collect data on the full range of patient-centered and clinical outcomes relevant to patients, caregivers and other stakeholders. In addition to health outcomes and clinical effectiveness, relevant outcomes include, as appropriate, the potential burdens and economic impacts.
As further detailed in the PFAs, the range of outcomes appropriate for inclusion stems from clarifications in PCORI’s reauthorizing legislation and is informed by Principles for the Consideration of the Full Range of Outcomes Data in PCORI-Funded Research.
Additional funding to implement results and advance shared decision-making
Three other PFAs seek proposals for projects to promote the uptake of results of PCORI-funded research as well as to implement effective shared decision making in healthcare settings. These PFAs reflect PCORI’s commitment to ensuring that PCORI-funded CER findings are easily accessible and useful to those who need them to make informed decisions about care.
Among the implementation PFAs, one opportunity seeks to fund projects with budgets up to $2.5 million in total costs in four areas of eligible evidence: obesity treatment in primary care settings, nonsurgical options to improve or eliminate symptoms for women with urinary incontinence, therapies and medicines for symptoms of posttraumatic stress disorder, and the use of narrow spectrum versus broad spectrum antibiotics to treat children’s acute respiratory tract infections.
Funding to advance methods and promote rigor in CER
An additional PFA providing up to $12 million seeks proposals for studies on improving methods to conduct patient-centered CER to enhance the scientific rigor of research. The priorities for this PFA include proposals to develop methods to improve the use of artificial intelligence and machine learning in clinical research, improve study design, methods to support data research networks, and proposals addressing ethical issues in patient-centered outcomes research/CER.
To date, PCORI has invested $3.4 billion to fund patient-centered CER and related projects, including those focused on implementing useful findings from PCORI-funded research and on supporting the engagement of people in research projects.
The Patient-Centered Outcomes Research Institute (PCORI) is an independent nonprofit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers and clinicians with the evidence-based information needed to make better-informed healthcare decisions. PCORI is committed to continually seeking input from a broad range of stakeholders to guide its work.
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