Improving Methods for Conducting Patient-Centered Outcomes Research - - PowerPoint PPT Presentation

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Improving Methods for Conducting Patient-Centered Outcomes Research

Letter of Intent (LOI) Applicant Town Hall Cycle 2 2015 July 8, 2015

Introductions Improving Methods Requirements Administrative Requirements Resources

Submitting Questions:

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Agenda

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PCORI CER Methods Program and Contracts Staff

Rachael Fleurence, PhD Program Director, Methods and Infrastructure Jason Gerson, PhD Associate Director, Methods Jason Rotter, MHS Program Associate, Methods Kate McQueston, MPH Program Associate, Methods Maryan Zirkle, MD, MS, MA Program Officer, Methods and Infrastructure Emily Evans, PhD, MPH Program Officer, Methods Kathryn Smith, MPH Program Assistant, Methods Andrea Heckert, PhD, MPH Program Officer, Methods Ashton Burton Contracts Specialist, Contracts

Improving Methods Requirements

PFA Overview: Improving Methods for Conducting Patient-Centered Outcomes Research

Available Funds and Duration:

• A total of $12 million (direct +

indirect) for this cycle

• Up to $750,000 in total direct

costs per project

• Maximum project period 3

years

Objectives of this PFA

PCORI seeks to fund projects to address gaps in methodological research relevant to conducting PCOR. The improvement of existing methods will benefit all stakeholders:

• researchers planning investigations
• policy makers weighing the value of healthcare

interventions

• patients, clinicians, and caregivers facing

healthcare decisions

PFA no longer includes 3 Special Topics of Interest

• Research related to Human Subjects Protections

– Previously Special Topic of Interest #1, now Research Area of Interest #3

• Research related to Recruitment and Retention

– Previously Special Topic of Interest #2, now part of Research Area of Interest #1

• Methods To Support Data Research Networks

– Previously Special Topic of Interest #3, Now Research Area of Interest #6 Extra scrutiny for projects overlapping with current portfolio

• While we will still consider applications related to analytic methods

responsive to this PFA, these applications will undergo substantial scrutiny to ensure that the proposed research does not significantly overlap with previously funded projects or concurrent proposals.

• See Research Areas of Interest #4 and #5 for more details.

Revisions for Cycle 2 2015 Funding Cycle

1. Methods for patient and stakeholder engagement 2. Methods for Patient-Centered Outcomes (PCOs) and Patient-Reported Outcomes (PROs) 3. Research related to Human Subjects Protections 4. Methods to Improve Study Design 5. Methods To Improve Validity and Efficiency of Analyses 6. Methods To Support Data Research Networks

Research Areas of Interest

• Description of the plan for engaging patients, caregivers, and/or other

stakeholders over the course of the project

– Justification for choice of patients, caregivers, and/or other stakeholders – Delineation of their roles and expected contributions

• Consider engaging other stakeholders in the methodological process

and dissemination and implementation plans

– Examples: data architects, clinicians, domain experts, health services researchers with different expertise than members of the research team, policy makers, etc.

Patient and Stakeholder Engagement Plan

Administrative Requirements

• Any private sector (non-profit or for-profit) research organization
• Any public sector research organization (university or college hospital
• r healthcare system, laboratory or manufacturer, unit of local, state,
• r federal government)
• Non-domestic components of organizations based in the US 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.

• Individuals are not permitted to apply.

Eligibility to Submit a Proposal

Funds & Budget Total Direct costs up to $750,000 over the life of the project Indirect costs: up to 40% Institutional base salary up to $200,000 Period of Performance Maximum of 3 years

Budget and Period Limitations

This is a competitive LOI process: Only those LOIs deemed most responsive to this PFA will be invited to submit a full application. All applicants will be notified of their status by September 8, 2015 by 5:00pm ET. Download the LOI Template from the Funding Center to begin your LOI.

• LOIs cannot exceed 3 pages and margins cannot be altered .
• Adhere to the formatting and template requirements in the Application

Guidelines.

• You must upload your LOI as a PDF in PCORI Online.

Please refer to the PFA, Application Guidelines, and Applicant Resources in the Funding Center here http://www.pcori.org/announcement/improving-methods- conducting-patient-centered-outcomes-research-cycle-2-2015

Letter of Intent (LOI)

Key Dates

What When

Using the PCORI Online System

• Apply through PCORI Online

(https://pcori.fluxx.io)

• Access the website using Chrome or Safari

browsers only

• Create a new request and begin the LOI
• Designate the LOI with the following

individuals:

• PI, PI Designee, Administrative

Official, and Financial Officer

• Enter information into all required fields

in the system

• Upload the LOI in the system

Where can I find help?

Visit pcori.org/apply

• Application Guidelines
• FAQs
• PCORI Online User Manuals
• Sample Engagement Plans

Schedule a Call with a Program Officer

• Submit a request at pcori.org/content/research-inquiry
• Call 202-627-1884 (programmatic inquiries)
• E-mail sciencequestions@pcori.org

Contact our Helpdesk

• E-mail pfa@pcori.org
• Call 202-627-1885 (administrative and

technical inquiries)

Q&A

Ask a question via the chat function in Meeting Bridge. Ask a question via phone (an operator will standby to take your questions).

If we are unable to address your question during this time, e-mail the Helpdesk at pfa@pcori.org.