Pragmatic Clinical Studies to Evaluate Patient-Centered Outcomes - Cycle 3 2015
Patient-Centered Outcomes Research Institute (PCORI) seeks to fund pragmatic clinical trials, large simple trials, or large-scale observational studies that compare two or more alternatives for addressing prevention, diagnosis, treatment, or management of a disease or symptom; improving healthcare 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 not requiring that relevant national patient organizations, professional organizations, and/or payer or purchaser organizations be formally included as partners and active participants prior to contract award. However, applicants should document that they have consulted with patients and other stakeholders to identify the important decisional dilemmas and evidence needs that will drive development of the research questions or reference previously documented decisional dilemmas. Successful applicants are required to work in collaboration with PCORI staff upon award of the studies to establish a project Study Advisory Committee (SAC) that is comprised of national or regional organizations that represent, at minimum, patients and/or families with lived experience, relevant clinicians, payers, and health plans. Other representation may be recommended in collaboration with PCORI including individual patients with lived experience and other relevant stakeholders, including scientific and methodological experts. The SAC serves to advise and assist the research team with further refinement of the study questions, outcomes and protocol. 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 analyses, systematic reviews (with or without meta-analyses), or 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, and 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. The Internal Revenue Service must recognize all U.S. applicant organizations. Nondomestic components of organizations based in the United States and foreign organizations may apply, as long as there is demonstrable benefit to the U.S. healthcare system and U.S. 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.
- Potential for the study to fill critical gaps and generate actionable evidence
- Potential for the study findings to be adopted into clinical practice and improve delivery of care
- Scientific Merit (Research design, analysis, and outcomes)
- Patient and stakeholder engagement
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.