Symptom Management in Patients with Advanced Illnesses Applicant - - PowerPoint PPT Presentation

Symptom Management in Patients with Advanced Illnesses

Applicant Town Hall Session

September 13, 2017 1:00 – 2:00 PM EST

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I. Welcome and Introductions

• II. Application Tips
• III. Patient Engagement and Engagement Plan
• IV. Review of Contractual Issues
• V. Merit Review Process
• VI. Applicant Resources

VII.Questions

Town Hall Overview and Agenda

Submitting Questions:

Submit questions via the question function in GoToWebinar Ask a question via phone by raising your hand at the end

• f the presentation

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• I. Welcome and Introductions

Terri Gleason, PhD Senior Program Officer, Clinical Effectiveness and Decision Science Bill Lawrence, MD, MS Associate Director, Clinical Effectiveness and Decision Science Roycelynn Mentor- Marcel, PhD, MPH Merit Review Officer, Merit Review Lauren Massey Associate, Contracts Operations, Contracts Management and Administration

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Chinenye Anyanwu, PharmD, MPH Engagement Officer, Public and Patient Engagement Kim DiGioia, MS Program Associate, Clinical Effectiveness and Decision Science

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• II. Application Tips

• To begin, all applicants should:
• Re-read the funding announcement and review the PCORI Application

Guidelines Document

• Review the PCORI Research Plan Template
• Review PCORI feedback on your LOI
• Then start with application package
• PCORI Online can be found at pcori.force.com/engagement

Preparing Your Application

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• Clearly describe comparators
• Document evidence of efficacy/effectiveness for the intervention and

comparator(s) and/or demonstrate that they are in widespread use clinically

• Provide a sound rationale for why the research question of interest is important

to patients, clinical dilemma and the significance of the clinical meaningfulness

• f outcomes
• Clearly demonstrate the feasibility of the study

– Show that you have the team to do this and you are the right team – Describe and support your recruitment and retention plan – Document that sites are already committed to participating – Include realistic timelines for study start-up, IRB approval, and recruitment

Tips for Success

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Research Strategy: Patient Population and Recruitment

• For this PFA it is critical to fully describe the patient population in

relation to the goals, including how they meet the definition of advanced illness, mapped to eligibility criteria etc.

• Describe the total pool of potential participants, those estimated to

be eligible, and the expected participation rate and references

• Discuss past experience with recruitment of the target population
• Provide preliminary evidence of the potential for successful

recruitment and document rationale for proposed retention rate

• Discuss barriers to recruitment and retention and how you plan to
• vercome them
• Discuss how and why study sites were selected

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• III. Patient Engagement and Engagement Plan

Engagement Rubric

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• Provides practical guidance to applicants, merit reviewers, awardees, and

engagement/program officers on effective engagement in research

• Planning the Study: How patient and stakeholder partners will participate in

study planning and design

• Conducting the Study: How patient and stakeholder partners will participate in

the conduct of the study

• Disseminating the Study Results: How patient and stakeholder partners will be

involved in plans to disseminate study findings and ensure that findings are communicated in understandable, usable ways

• PCOR Engagement Principles: Reciprocal relationships, co-learning, partnership,

trust, transparency, honesty

Core Engagement Principles

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• Reciprocal relationships
• Co-learning
• Partnership
• Trust, transparency, honesty

Considerations for Engagement

Leadership

Budget Structure Level of Involvement (MOUs)

Representativeness

Training

Information sharing Evaluation Dissemination

• PCORI’s Engagement Rubric:

http://www.pcori.org/sites/default/files/Engagement-Rubric.pdf

• Sample Engagement Plans: http://www.pcori.org/sites/default/files/PCORI-

Sample-Engagement-Plans.pdf

• Compensation Framework: http://www.pcori.org/sites/default/files/PCORI-

Compensation-Framework-for-Engaged-Research-Partners.pdf

• Engagement Budgeting: http://www.pcori.org/sites/default/files/PCORI-

Budgeting-for-Engagement-Activities.pdf

• Engagement in Research Website: http://www.pcori.org/funding-
• pportunities/what-we-mean-engagement

Applicant Resources – Engagement

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• Financial compensation of partners
• Expenses of partners (transportation, childcare, caregiver)
• Budgeting for program staff dedicated to engagement tasks
• Costs of engagement meetings and events (travel, food, AV)
• Additional time and resource to incorporate partner feedback into various

project process

Allowable Engagement Budget Items

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• IV. Applying for a PCORI Award

Tips for Success

• Start and submit early
• Download PCORI’s Online User Manual for Submitting an Online

Application

• Ensure that all team members can see the application in the

system (check during the LOI stage)

• Inform your AO of your intent to submit
• Submit the completed application before the due date, October 25, 2017,
• r on it by 5:00 PM ET

Common Application Errors

• Using the wrong browser
• Access PCORI Online via Chrome or Safari browsers
• Not entering information into all required fields in the system
• Not clicking the ‘Save’ button
• Having multiple people working on the application at the same time
• Having the incorrect file extension
• Only PDF files can be uploaded
• Not choosing the correct document type from the drop-down menu
• AO is unable to view the application

Letter of Intent and Application You were invited to submit a full application based on the information provided in the LOI. Please remember: Changes after the LOI require PCORI approval.

Show stoppers include:

Changes to the PI Changes to the Institution Changes to the Study Design Changes to the Budget/ Period of Performance Changes to Research Question Changes to Specific Aim Changes to Comparators Email pfa@pcori.org to request any changes at the application stage.

Budget Templates: Overview

Three budget sections must be submitted as part of the online application process:

Detailed Budget Budget Summary Budget Justification NOTE:

A detailed budget is needed for each year of the

• program. Complete each budget section for the prime

applicant and any/each subcontractor.

Budget Justification

• Narrative that fully supports and explains the basis for the information in

the Budget Detail

• Provide sufficient detail to understand the basis for costs, the reason that the

costs are necessary, and an explanation for major cost variances

• Use the budget template to tell PCORI why the costs are reasonable for the

work to be performed

• Breakdown of costs proposed for each consortia or contractor
• Must specify any other sources of funding that are anticipated to support

the proposed research project

• Provide quotes, indirect cost rate letter, fringe benefit policy

Costs of Interventions

• PCORI will not cover costs for clinical care interventions that are being

compared in the project.

• PCORI will consider covering costs for ancillary tasks necessary in the

implementation or monitoring of a clinical intervention or strategy as part

• f the research program.
• Examples include costs for obtaining consent, collecting data, or

monitoring that would not normally be performed in routine care

• Support for the study by the involved healthcare delivery systems must be

documented.

What happens to your application after you submit it?

Administrative Screening

Applicants must follow administrative requirements set in PCORI’s Application Guidelines.

► Exceeding page limits, budget, or time limitations ► Not using PCORI’s required templates ► Submitting incomplete sections or applications

Missing the Mark

Programmatic Screening

► Study deviates from approved LOI ► Study includes cost-effectiveness analysis ► Study is not responsive to PFA and/or does NOT

address the PFA’s “Research Areas of Interest”

► Study is not comparative

Missing the Mark PFA Responsiveness PCORI Mission Advance Through to Merit Review

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• V. Merit Review

Merit Review

• Multistep process:

– Full applications screened by committee of PCORI staff for responsiveness to PFA and consistency with LOI – Preliminary (online) review – In-Person review – Post-Panel review (PCORI program staff)

• Merit Review Officers assign applications to reviewers based on

reviewer expertise.

Merit Review Criteria

Crosswalk of PCORI Merit Review Criteria with NIH Criteria SIGNIFICANCE

• 1. Potential for the study to fill critical gaps in evidence
• 2. Potential for the study findings to be adopted into clinical

practice and improve delivery of care APPROACH

• 3. Scientific merit (research design, analysis, and outcomes)
• 4. Investigator(s) and environment

PCORI-only Merit Review Criteria PATIENT-CENTEREDNESS/ ENGAGEMENT

• 5. Patient-centeredness
• 6. Patient and stakeholder engagement

Methodology Standards

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More info here: https://www.pcori.org/document/methodology-standards-checklist https://www.pcori.org/research-results/about-our- research/research-methodology/pcori-methodology-standards

• Standards for Formulating Research

Questions

• Standards Associated with Patient-

Centeredness

• Standards for Data Integrity and Rigorous

Analyses

• Standards for Preventing and Handling

Missing Data

• Standards for Heterogeneity of Treatment

Effect (HTE)

• Standards for Data Registries
• Standards for Data Networks as Research-

Facilitating Structures

• Causal Inference Standards
• Standards for Adaptive and Bayesian Trial

Designs

• Standards for Studies of Medical Tests
• Standards for Systematic Review
• Standards on Research Designs Using

Clusters

Building an Inclusive Merit Review

• Panels include 3 reviewer types to bring diverse perspectives to the merit

review process

• Each application is reviewed by 3 scientists, 1 patient and 1 other

stakeholder

• PCORI guides reviewers to use the bullet points under each merit review

criterion to evaluate their assigned applications (see Merit Review section in PFA)

Patients Other Stakeholders Scientists Including 1 methodologist

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• VI. Need to Know

Submission and Key Dates

What When Application Deadline October 25, 2017 at 5:00pm EST Merit Review Dates January 2018 Awards Announced May 2018 Earliest Start Date August 2017

Where can I find help?

Visit pcori.org/apply – this is the Funding Center

• 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
• E-mail sciencequestions@pcori.org

Contact our Helpdesk

• E-mail pfa@pcori.org – administrative and technical inquiries
• E-mail help@pcori.org – PCORI Online help

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• VI. Q&A

Ask a question via the chat function in GoToWebinar Ask a question via phone – raise your hand and we will unmute your line

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

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