Large Pragmatic Studies to Evaluate Patient-Centered Outcomes - Winter 2015 Cycle
Patient-Centered Outcomes Research Institute (PCORI) seeks to fund pragmatic clinical trials (PCTs), large simple trials (LSTs), or large-scale observational studies that compare two or more alternatives for addressing prevention, diagnosis, treatment, or management of a disease or symptom; improving health care system–level approaches to managing care; or eliminating health or healthcare disparities.
Proposed studies must address critical clinical choices faced by patients, their caregivers, clinicians, and/or delivery systems. They must involve broadly representative patient populations and be large enough to provide precise estimates of hypothesized effectiveness differences and to support evaluation of potential differences in treatment effectiveness in patient subgroups.
For this solicitation, PCORI is requiring that relevant patient organizations, professional organizations, and/or payer or purchaser organizations be included as partners and active participants in the study. PCORI expects that most awards will be made for study designs that use randomization, either of individual participants or clusters, to avoid confounding bias. However, we recognize that exceptional opportunities may arise, by virtue of natural experiments and/or the existence of large registries, to address pragmatic questions using observational designs. Please note that this funding program does not support applications to conduct cost-effectiveness analysis, systematic reviews (with or without meta-analysis), development, and/or evaluations of shared decision-making or decision support tools.
This announcement is a collaborative effort of PCORI’s Clinical Effectiveness Research, Improving Healthcare Systems, and Addressing Disparities research programs. Thus, applications for pragmatic studies may fit within any of these three priority areas.
Applications may be submitted by any private sector research organization, including any nonprofit or for-profit organization; any public sector research organization, including any university or college hospital or healthcare system, laboratory, or manufacturer; or unit of local, state, or federal government. All US applicant organizations must be recognized by the Internal Revenue Service. Nondomestic components of organizations based in the US and foreign organizations may apply as long as there is demonstrable benefit to the US healthcare system, and US efforts in the area of patient-centered research can be clearly shown. Organizations may submit multiple applications for funding. Individuals are not permitted to apply.
1. Impact of the condition on the health of individuals and populations
2. Potential for the study to improve healthcare and outcomes
3. Technical merit
5. Patient and stakeholder engagement
Letters of Intent will be screened for responsiveness to this PCORI Funding Announcement (PFA) and fit to program goals. Only those applicants selected will be permitted to submit full applications. Notification of request to submit a full application will occur no later than October 31, 2014.
Deadlines are at 5:00 p.m. (ET). If deadlines fall on a weekend or a federal holiday, the deadline will be the following Monday or the next day after the federal holiday.