Letter of Intent Town Hall for Applicants August 2013 Cycle

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Agenda

Introductions

About PCORI

PCORI Funding Announcements (PFA)

Overview of PFA

Merit Review Criteria

Letter of Intent Overview

Resources

Live Q&A

Submitting Questions:

Submit questions via the chat function in Meeting Bridge

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

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Introductions

Martin Duenas, MPA Contracts Director

James Hulbert Contracts Administrator

Kirstin Margosian, MA Contracts Coordinator

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Rachael Fleurence, PhD Program Director

About PCORI

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PCORI’s Mission and Vision

The Patient-Centered Outcomes Research Institute (PCORI) is an independent, non-profit health research organization authorized by the Patient Protection and Affordable Care Act of 2010.

PCORI funds patient-centered research to assist patients, caregivers, and other stakeholders in making informed health decisions.

Mission

PCORI helps people make informed healthcare

decisions and improves healthcare delivery and

outcomes by producing and promoting high integrity,

evidence-based information that comes from research

guided by patients, caregivers, and the broader

healthcare community.

Vision

Patients and the public have the information they need to make decisions that reflect

their desired health outcomes.

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Research Done Differently

PCORI’s unique contribution to this field of research is its dedicated focus on outcomes that matter most to patients.

Inclusion of patient-centered outcomes is therefore a necessary component of PCORI-funded research.

PCORI involves patients and the entire healthcare community in every step of the research process — from selecting research questions to study, to the actual conduct of research, to sharing the research findings through platforms and channels that are accessible to everyone.

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PCORI Funding Announcements

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Overview of PFAs

To solicit research proposals, PCORI regularly releases funding announcements that invite researchers to submit applications to receive funding to conduct research projects:

Addressing Disparities

Assessment of Prevention, Diagnosis, and Treatment Options

Communication and Dissemination Research

Improving Healthcare Systems

Improving Methods for Conducting Patient-Centered Outcomes Research

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Improving Methods for Conducting Patient-Centered Outcomes Research

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Improving Methods for Conducting Patient-Centered Outcomes Research

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In this PFA, we seek to fund projects that: Improve methods for engaging patients/stakeholders in

PCOR and for evaluating the impact of this patient/ stakeholder engagement.

Improve methods for systematic review of PCOR topics, including selection and prioritization of topics.

Improve the validity and/or efficiency of analytic methods and data sources utilized in PCOR research.

Improve methods to support the collection of Patient-Reported Outcomes and Patient-Centered Outcomes.

Improve methods to enhance the reproducibility, transparency, and replication of PCOR research.

Improve approaches for training researchers, patients, and other stakeholders in PCOR methods.

Available funds: Up to $8 Million

Studies PCORI Is Not Soliciting Under This PFA

Studies whose primary focus is not on improving methods for PCOR: Studies should address gaps identified under the research areas of interest in the PFA and the Methodology Committee report.

Studies whose primary focus is on developing or studying a disease-specific intervention, model, test, instrument, tool or other items without the primary objective being to address a methodological gap in PCOR as identified in the Methodology Committee report or in other recognized sources.

Examples of non-responsive studies: 1. Study whose main focus is to evaluate the response to an intervention in patients with a specific disease. 2. Development of a tool to improve patient-physician communication around a difficult diagnosis.

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Broad Research Topics of Interest

The following topics areas are areas of research that PCORI might be interested in:

Development of methods for patient-centeredness.

Research in methods to conduct systematic reviews of patient-centered CER.

Development of methods for generating, selecting, and prioritizing topics for research and for including patients and stakeholders in the peer-review process.

Development and refinement of general analytic methods.

Development and refinement of design-specific analytic methods.

Research that determines the validity and efficiency of data sources commonly used in PCOR.

Research related to Patient-Centered Outcomes (PCOs) and Patient-Reported Outcomes (PROs).

Research in methods to enhance the reproducibility, transparency, and replication of PCOR.

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Merit Review Criteria

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Merit Review Criteria

Applicants must respond to the five PCORI Merit Review Criteria.

1. Impact on the field of PCOR methods

2. Potential for study to improve PCOR methods

3. Technical merit 4. Patient-centeredness

5. Patient and stakeholder engagement

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Criterion 1: Impact on the field of PCOR Methods

Refers to the extent that the proposed methods are needed in the field of PCOR. How often would these methods be used, and how many PCOR studies would

benefit from these improved methods?

Do existing methods weaken the validity of PCOR studies, and would improved methods therefore increase the validity of PCOR findings?

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Criterion 2: Potential for study to improve PCOR Methods

Refers to the potential of the proposed methodological investigation and its results to change methodological practices in ways that improve PCOR and the decisions made by patients. Does the research question address a critical gap in current methodological understanding as noted in the Methodology Committee Report or in other sources? Is the proposed approach feasible and likely to result in new standards or in the

improvement of existing standards?

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Criterion 3: Technical merit

Refers to the technical merit of the proposal. Is there a clear research plan with rigorous methods and key milestones clearly

articulated? Do the study methods reflect state-of the-art thinking and practice in the methodological area, so that results are likely to be accepted and heeded?

Is the research team appropriately trained and experienced to carry out the

planned studies? Is the research environment sufficient to support the conduct of the work, and are

appropriate resources available? Will the proposed methods help support the inclusion and study of diverse

populations with respect to age, gender, race, ethnicity, geography, or clinical status, or, alternatively, do the methods support the inclusion of previously understudied populations in PCOR?

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Criterion 4: Patient-centeredness

Refers to the level of patient-centeredness of the proposal. Is the proposed methodological investigation specifically linked to improving PCOR

methods, and specifically to the improved study of comparisons and patient-centered outcomes that are relevant and valued by patients, caregivers, and clinicians?

For relevant studies, how credible are the application’s claims that engaged

patients and stakeholders will exert meaningful influence on the design and conduct of the research, to ensure patient-centeredness of the questions and outcomes addressed?

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Criterion 5: Patient and stakeholder engagement

Refers to the level of engagement of patients and stakeholders in the proposed project. Where applicable, applications need to demonstrate patient and stakeholder engagement through the integration of patients and stakeholders in the development of the research plan and in key elements of the proposed project including:

• Participation in formulation of research questions • Defining essential characteristics of the study, participants,

comparators, and outcomes • Monitoring study conduct and progress • Dissemination of research results

If the project has not included patient and stakeholder engagement (for example,

in the area of analytic methods), has the application justified their non-inclusion?

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Letter of Intent (LOI) Submission: Deep Dive

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Understanding the Letter of Intent (LOI)

A LOI is required in order to submit an application.

LOI’s are NOT scored.

Applicants will NOT receive an invitation to submit an application after submitting a LOI.

An Investigator can only be listed as a PI on one.

Of note: PCORI encourages applicants to submit their LOI and application before the stated due date. LOIs and applications are due 5:00 pm ET.

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Eligibility Requirements

Applications may be submitted by: Any private sector research organization, including any:

• non-profit organization • for-profit organization

Any public sector research organization, including any:

• university or college • hospital or healthcare system • Laboratory or manufacture • unit of state or local government

Foreign Organizations

Nondomestic Components of Organizations based in the United States

Please Note: Individuals are not eligible to submit applications to PCORI.

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Budget and Period Limitations

Budget • Maximum $250,000 direct costs per year • Indirect costs are capped at 40% • *Request for exception can be made during the

LOI submission

Period of Performance • Maximum of three years • PCORI encourages projects of shorter duration • *Request for exception can be made during the

LOI submission

*Of note: Approval or denial decisions may take up to four months. Please plan accordingly, and factor this into your decision to submit a request.

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Letter of Intent

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The Letter of Intent includes: Organizational information Information about Key Personnel

Technical abstract (3,000 character limit)

• Background: State the problem or methodological gap your research intends to address, including the rationale for tackling this problem.

• Objectives: Briefly describe the specific aims of the study, including the methods gaps addressed.

• Methods: Give a concise description of the steps involved in the development of the new methodology.

• Anticipated impact: Describe the anticipated impact the study results will have on the field of PCOR methods.

Of note: This abstract may be used to determine programmatic fit.

Key Dates: August 15 2013

Key Dates: PCORI Funding Announcements

Action August 2013 Cycle

System Opening Date May 15

Letter of Intent (LOI) Due Date June 15

Informational Training Programs July – August

Application Deadline August 15

Merit Review Dates September - November

Awards Announced December / January

Earliest Start Date January

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Frequently Asked Questions (Programmatic) How do I know if my research is of interest to PCORI?

• We encourage you to read the PCORI Funding Announcements (PFAs) carefully and other background material on our website to understand our goals and the PFA you are considering.

Can I speak with someone at PCORI about the suitability of my research question? • Currently, PCORI does not have dedicated individuals to speak with applicants

regarding submission questions. Applicants and potential applicants with questions should submit those inquiries via pfa@pcori.org.

Is there a specific disease or condition that is a priority for PCORI?

• No. PCORI is concerned with patient outcomes, across a range of conditions and treatments. PCORI will periodically issue PFAs that focus on specific diseases or conditions within or across funding areas.

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Frequently Asked Questions (Administrative) Can I switch PFAs after a LOI has been submitted?

• No. It is not possible to submit an LOI to one funding announcement and the full application to another.

How much can the research proposed in my application differ from that initially

described in my Letter of Intent (LOI)? • The information provided in the LOI, including the study title, may be changed

in the final application. Only two things may not differ: • The PFA may not change. • The budget may not exceed direct cost and/or project period, as listed

within the PFA, if permission was not requested at LOI submission.

Can I list a different PI in the final application than was listed in the Letter of Intent (LOI)? • Yes. The PI listed on your final application may differ from the PI listed in the

LOI.

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Resources

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Resources

View training materials through the Quick Links for Applicants bar. Access: • Application training • Opportunities for webinars • Reviewer training

Visit the Funding Center for: • PFAs • Templates • Instructions • Key dates • FAQ’s

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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 question you may have about the PFA or the LOI submission process.

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

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