Symptom Management in Patients with Advanced Illnesses Applicant Town Hall Session September 13, 2017 1:00 – 2:00 PM EST 1
Town Hall Overview and Agenda I. Welcome and Introductions II. Application Tips III. Patient Engagement and Engagement Plan IV. Review of Contractual Issues V. Merit Review Process Submitting Questions: VI. Applicant Resources Submit questions via the VII.Questions question function in GoToWebinar Ask a question via phone by raising your hand at the end of the presentation 2
I. Welcome and Introductions Bill Lawrence, MD, MS Lauren Massey Chinenye Anyanwu, Associate Director, PharmD, MPH Associate, Contracts Clinical Effectiveness Operations, Contracts Engagement Officer, and Decision Science Management and Public and Patient Administration Terri Gleason, PhD Roycelynn Mentor- Kim DiGioia, MS Engagement Marcel, PhD, MPH Senior Program Officer, Program Associate, Clinical Effectiveness Merit Review Officer, Clinical Effectiveness and Decision Science Merit Review and Decision Science 3
II. Application Tips 4
Preparing Your Application • 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 5
Tips for Success • 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 of 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 6
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 • overcome them • Discuss how and why study sites were selected 7
III. Patient Engagement and Engagement Plan 8
Engagement Rubric • 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 9
Core Engagement Principles • Reciprocal relationships • Co-learning • Partnership • Trust, transparency, honesty 10
Considerations for Engagement Information Leadership sharing Level of Involvement Budget (MOUs) Evaluation Representativeness Structure Dissemination Training
Applicant Resources – Engagement • 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- opportunities/what-we-mean-engagement 12
Allowable Engagement Budget Items • 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 13
IV. Applying for a PCORI Award 14
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, or 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 Changes to Changes Changes Changes to Changes to Changes to the the Budget/ to to the Research Comparators to the PI Study Period of Specific Institution Question Design Performance Aim 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: Budget Budget Summary Detailed Budget Justification A detailed budget is needed for each year of the program. Complete each budget section for the prime NOTE: 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 of 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 Missing ► Submitting incomplete sections or applications the Mark
Programmatic Screening PFA Responsiveness Advance Through to Merit Review PCORI Mission ► Study deviates from approved LOI ► Study includes cost-effectiveness analysis Missing ► Study is not responsive to PFA and/or does NOT the Mark address the PFA’s “Research Areas of Interest” ► Study is not comparative
V. Merit Review 24
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 1. Potential for the study to fill critical gaps in evidence SIGNIFICANCE 2. Potential for the study findings to be adopted into clinical practice and improve delivery of care 3. Scientific merit (research design, analysis, and outcomes) APPROACH 4. Investigator(s) and environment PCORI-only Merit Review Criteria PATIENT-CENTEREDNESS/ 5. Patient-centeredness ENGAGEMENT 6. Patient and stakeholder engagement
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