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LOI Applicant Town Hall Webinar

Washington, DC

February 11, 2015 at 2:00 pm ET

Improving Methods for Conducting

Patient-Centered Outcomes

Research

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Introductions

Improving Methods Requirements

Administrative Requirements

Resources

Submitting Questions:

Submit questions via the chat function in Meeting Bridge.

Ask a question via phone (an operator will standby to take your questions).

Agenda

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PCORI CER Methods Program and Contracts

Staff

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Rachael Fleurence, PhDProgram Director,

Methods and Infrastructure

Jason Gerson, PhDAssociate Director,

Methods

Jason Rotter, MHSProgram Associate,

Methods

Kate McQueston, MPHProgram Associate,

Methods

Maryan Zirkle, MD, MS, MA

Program Officer, Methods and Infrastructure

Emily Evans, PhD, MPH

Program Officer, Methods

Kathryn Smith, MPHProgram Assistant,

Methods

Andrea Heckert, PhD, MPH

Program Officer, Methods

Nora McGhee, PhDMerit Review

Officer

Ashton BurtonContracts Specialist,

Contracts

Improving Methods Requirements

PFA Overview: Improving Methods for Conducting

Patient-Centered Outcomes Research

Available Funds and Duration:

• A total of $12million (direct + indirect) for this cycle

• Up to $750,000 in total direct costs per project

• Maximum project period 3 years

Objectives of this PFA:Research findings that can be trusted

should be generated using valid, rigorous,

patient-centered research methods.

PCORI seeks to fund projects to address

gaps in methodological research relevant

to conducting PCOR.

Improving existing methods to benefit all

stakeholders, including researchers

planning investigations, policy makers

weighing the value of healthcare

interventions, and patients, clinicians, and

caregivers facing healthcare decisions.

Revisions for Spring 2015 Funding Cycle

Decrease of award size from $1,000,000 to $750,000 in total direct costs

Research related to human subjects protections and novel interventions for recruitment

and retention are now designated as Special Topics of Interest

Revised Special Topic of Interest focusing on methods for network-based data in research

The current PFA does not include a special emphasis on PROMIS related projects. We

will still consider projects that include PROMIS measures, provided they align with the S15

PRO/PCO priorities

No support for methods related to research prioritization and systematic reviews

Research Areas of Interest

Development of methods for patient and other stakeholder engagement in research

Development and refinement of general analytic methods

Development and refinement of design-specific analytic methods

Research related to patient-centered outcomes (PCOs) and

patient-reported outcomes (PROs)

Research on usefulness of patient-reported data in clinical care

Research on PRO score interpretability, with a focus on clinical

meaningfulness

Research on the collection of PRO data for multiple purposes

Research on integrating PROs into clinical practice

Research on the use of PROs in registries

Special Topics of Interest

Research on issues related to human subjects protections

Research on novel methods, interventions, or strategies for

increasing recruitment and retention of participants

Development of methods to support data research networks

Methods to improve distributed analyses in data research networks

Methods to obtain longitudinal and complete data in data research

networks

Patient and Stakeholder Engagement Plan

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.

Administrative Requirements

Eligibility to Submit a Proposal

Any private sector (non-profit or for-profit) research

organization

Any public sector research organization (university or

college hospital or healthcare system, laboratory or

manufacturer, unit of local, state, or 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.

Budget and Period Limitations

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

Letter of Intent (LOI)

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 March 23, 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/assets/2014/08/PCORI-PFA-2014-Fall-

Methods-Application-Guidelines.pdf

Submission & Key Dates

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What When

LOI-Applicant Town Hall February 11, 2015 at 2:00 pm ET

LOI due in PCORI Online March 6, 2015 by 5:00pm ET

Applicants notified as to

whether they have been

selected to submit a full

application

March 23, 2015 by 5:00pm ET

Application Deadline (by

invitation only)May 5, 2015 by 5:00pm ET

Merit Review Dates August 6-7, 2015

Awards Announced September 30, 2015

Earliest Start Date November 2015

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, AO, and Financial Officer

Enter information into all required fields in the system

Upload the LOI in the system

Save information by clicking the ‘Save and Review’ button on the save and review page and on the side navigation pane

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/programmatic-inquiry Call 202-627-1884 ( programmatic inquiries) Submit a request at pcori.org/about-us/contact-us

Contact our Helpdesk E-mail pfa@pcori.org Call 202-627-1885 ( administrative and

technical inquiries)

Questions

Submitting Questions:

Submit questions via the chat function in Meeting Bridge.

Ask a question via phone (press 7 on your phone).

Please use this time to ask any programmatic and administrativequestions you may have about the PFA or LOI submission process.

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