Letter of intent deadline: October 1, 2014
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.