Pragmatic Clinical Studies and Large Simple Trials to Evaluate Patient-Centered Outcomes
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 healthcare system–level approaches to managing care; or for 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 actively participate 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.This new PCORI program will not support proposals to conduct evidence synthesis or to develop decision-support tools. This announcement is a collaborative effort of PCORI’s Clinical Effectiveness, Improving Healthcare Systems, and Addressing Disparities research programs. Thus, proposals 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 United States 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 health care and outcomes
3. Technical merit
5. Patient and stakeholder engagement
*Letters of Intent will be screened for responsiveness and fit to program goals. Only those selected will be permitted to submit full applications. Notification of request to submit full application will occur no later than April 7, 2014. PCORI encourages prospective applicants to contact us with questions prior to the deadline.
**Deadlines are at 5:00 PM 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.