|Letters of Intent (LOI) for this PFA were due May 4, 2016, by 5:00 p.m. (ET).
Those selected to submit a full application were notified by June 10, 2016.
Full applications were due August 8, 2016, by 5:00 p.m. (ET).
Research Initiative Highlights
PCORI seeks to fund pragmatic clinical trials that compare surgical and nonsurgical options for management of nonspecific chronic low back pain. The research is expected to examine treatment options, as well as systems-level interventions or those aimed at eliminating health or healthcare disparities.
Proposed studies must address clinical and healthcare delivery choices faced by patients, their caregivers, clinicians, or delivery systems. Proposed studies must compare two or more active interventions. They must involve patient populations that represent the U.S. population; be large enough to provide precise estimates of hypothesized effectiveness differences; and be large enough to support evaluation of potential differences in treatment effectiveness in patient subgroups.
For this solicitation, 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. Although PCORI does not require that relevant national patient organizations, professional organizations, and payer or purchaser organizations be formally included as partners and active participants prior to contract award, successful applicants may be required to develop such formal arrangements. PCORI may require a project Study Advisory Committee (SAC) that is comprised of national or regional organizations that represent, at a minimum, patients and families with lived experience, relevant clinicians, payers, and health plans. Scientific and methodological experts may also be recommended for this oversight role. The SAC advises and assists the research team with refining the study questions, outcomes, and protocol. PCORI expects applications to follow the randomized controlled trial (RCT) study design specified for the research question. Note that this funding program does not support applications to conduct cost-effectiveness analysis, systematic reviews, or development and evaluation of shared decision making or decision-support tools.
The proposed studies must address the priority research question identified in the main body of the PFA.
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 U.S. applicant organizations must be recognized by the Internal Revenue Service.
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