Pragmatic Clinical Studies and Large Simple Trials to Evaluate Patient-Centered Outcomes

Letter of Intent Deadline:

March 10, 2014 at 5:00 p.m. (ET)

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.

Summary:

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 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.

Full Announcement:

Pragmatic Clinical Studies and Large Simple Trials to Evaluate Patient-Centered Outcomes

*Key Dates:

Online System Opens

February 5, 2014

Applicant Town Hall Session

February 12, 2014 at 11:00 AM (ET)

Letter of Intent (LOI) Due

March 10, 2014 at 5:00 pm ET

LOI Screening Notification

April 7, 2014

Application Deadline (by invitation only)

August 8, 2014 at 5:00 pm ET

Merit Review Dates

November 2014

Awards Announced

January 2015

Earliest Start Date

April 2015

Total Costs:

$10 Million (Total Direct Costs)

Maximum Project Period:

5 Years

Funds Available Up To:

$90 Million

Eligibility:

Applications may be submitted by any private sector research organization, including any non-profit or for-profit organization; any public sector research organization, including any university or college hospital or healthcare system, laboratory or manufacturer, unit of local, state or federal government. All US applicant organizations must be recognized by the Internal Revenue Service. Non-domestic 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.

Review Criteria:

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

4. Patient-centeredness

5. Patient and stakeholder engagement

Applicant Resources:

Applicant FAQs

Applicant Town Hall Webinar Archive

Application Checklist

PCORI Application Guidelines

Budget Justification Template

Budget Summary for the Entire Project Template

Detailed Budget Template

Engagement Template

Frequently Asked Questions

Methodology Report and Standards

People and Places Template

PCORI Funded Projects: Sample Engagement Plans

PCORI Online System

PCORI Online System User Manual: Submitting a Letter of Intent

PCORI Online System User Manual: Submitting an Application (Pragmatic Studies)

PCORI Policy on Submission of Research Contract Applications

Research Plan Template

Research Topics of Interest

Sample Contract for Funded Research Projects

Technical Abstract Template

Other:

*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.