Symptom Management in Patients with Advanced Illnesses Applicant Town Hall June 19, 2018 Cycle 2 2018
Agenda • Programmatic Overview • Administrative Overview • Engagement Overview • Merit Review Criteria • Questions and Answers Submit questions via the Question box in GoToWebinar control panel
Today’s Presenters Sarah Daugherty, Denese Neu, PhD PhD, MPH Roycelynn Engagement Senior Program Mentor- Lauren Massey Officer Officer Marcel, PhD, Contract MPH Administrator Merit Review Officer 3
Programmatic Overview Sarah Daugherty, PhD, MPH Senior Program Officer, Clinical Effectiveness and Decision Science 4
Symptom Management Evidence Gap Continues • Limited number of large trials with long-term outcomes evaluating head-to-head comparisons of pharmacological and non-pharmacological treatments. • Additional research is needed in symptom management on: – Illnesses other than advanced cancer – Pediatric and adolescent populations – Full range of clinically meaningful outcomes including caregiver outcomes – Long term follow-up 5
Cycle 2 2018: Symptom Management PFA Available Funds & PCORI seeks to fund high-quality • Project Duration: clinical studies that compare the effectiveness of evidence-based • Competitive LOI treatments for relief of common symptoms experienced by patients Process with life-limiting advanced illness . • Up to $2 Million in total direct costs per The Cycle 2 2018 Symptom • project Management PFA is available at https://www.pcori.org/funding- opportunities/announcement/sympto • Projects should be m-management-patients-advanced- completed within 3 illness-cycle-2-2018 years 6
Reposting of Symptom Management PFA What has NOT Changed: • Advanced illness population with high symptom burden and life-limiting disease. • Minimum length of follow-up is six months. Changes Made in Requirements : • Proposed interventions may include pharmacological treatments, nonpharmacological approaches, a combination, or complementary therapies. A pharmacological intervention is encouraged but not required. • Depression was removed from symptom list. 7
Symptoms of Interest are Limited to PFA List • Symptoms of interest include and ARE limited to: – Pain – Fatigue – Dyspnea – Insomnia – Anorexia/cachexia – Nausea/vomiting – Anxiety 8
PCORI Areas of Interest in Symptom Management PFA • Population: Patients, of any age, with life-limiting advanced illness. • Intervention : Head-to-head comparison of clinical treatment options with demonstrated efficacy. • Outcomes : Diverse type and source of relevant outcomes. • Follow-up : Long-term ascertainment of outcomes. 9
General Guidance for Resubmissions If you are resubmitting an LOI, be clear about what scientific and • logistical changes have been made in the revised LOI. DO NOT SUBMIT the same LOI as last cycle. If your LOI is invited for full application, please provide a resubmission • letter identifying the changes that have been made in the revised research plan. 10
Application Guidance Adhere to the PFA and Application Guidelines • Provide a sound rationale for why the research question as proposed is • important to patients. Clearly demonstrate the feasibility of the study. • – Show that you have the right team. – Describe and support your recruitment and retention plan. – Document sites are already committed to participating. – Include realistic timelines for study start-up. Demonstrate adherence to the PCORI Methodology Standards . • 11
Tips for Success - Programmatic Propose a comparative effectiveness study that matters to patients. • Justify the choice of the population and setting. • Provide evidence of efficacy of the intervention and comparator(s) for • the symptom of choice through citations or demonstrate widespread use in the population proposed. Justify the hypothesized effect size with citations that support efficacy • of the interventions within the proposed population. Address the LOI feedback you receive from PCORI in your full • application. 12
Tips for Success - Administrative • Submit the completed Letters-of-Intent (LOI) by June 28, 2018 by 5:00 pm ET. • Provide all information requested, as outlined in the LOI and Application template. • For programmatic inquiries, please email the Helpdesk at pfa@pcori.org 13
Administrative Overview Lauren Massey Contract Administrator, Contract Management 14
Using the PCORI Online System • Register as a New User and create your LOI as soon as possible • Please note that the PI and AO cannot be the same person • Please only use Chrome, Safari, and Firefox browsers to access the system • https://pcori.force.com/engagement • PCORI Online Training Slides • PCORI Online Application Cheat Sheet • PCORI Online Training Resources 15
Letters of Intent to Apply: Eligibility to Submit 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. • 16
Letter of Intent (LOI): Requirements An LOI is required and must be submitted prior to the deadline. Letters of • Intent are due Thursday, June 28, 2018, by 5:00 p.m. ET. To submit an LOI, download the 2018 Cycle 2 Symptom Management Letter • of Intent Template from the Funding Center to begin your LOI. You must answer all questions. • Do not upload additional documents as part of your LOI. Letters of • endorsements or support are not accepted at this stage. Only those LOIs deemed most responsive (programmatically and • administratively) to this PFA will be invited to submit a full application. 17
From LOI to Application • Full applications are invited based on the information provided in the LOI. • Changes to the following require PCORI’s approval: • Principal investigator • Institution • Research question(s) • Specific aims • Study design • Comparators • Budget/period of performance 18
19 Applying for a PCORI Award
Invited to Apply: Tips for Success • Start and submit application early • Have a copy of your approved LOI readily accessible • 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 on/before the due date by Tuesday, September 25, 2018, by 5:00 p.m. ET. 20
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
Application Components: Research Plan Research Strategy: 12 pages • – Provide all the information requested, as outlined in the template: *Specific Aims *Significance *Background *Study Design or Approach Research Team & Environment: 2 pages • – Describe the research team’s capabilities to accomplish the goals of the proposed research project and the appropriateness of the research environment to conduct the study. Dissemination & Implementation: 1 page • – Describe how you will make study results available to study participants after you complete the analyses, and possible barriers to disseminating and implementing the results of this research in other settings. Protection of Human Subjects : 5 pages • – PCORI follows the Federal Policy for the Protection of Human Subjects (45 CFR part 46), including the Common Rule. 22
Application Components: Research Plan (cont.) Consortium Contractual Arrangements: 10 pages • - Describe the proposed components of the research project that will be performed by subcontracted organizations. - Explain the strengths that these partners bring to the overall project to ensure successful submission of contract deliverables in accordance with the milestone schedule. References Cited: 10 pages • - List the full bibliographical citation for each reference. Each reference must include the names of all authors the article title and journal or book title, the volume number, the page numbers, and the year of publication. Appendices: 10 pages (optional) • - Applicants can include additional materials that they believe are useful, but reviewers are not required to review the appendix materials in evaluating the application. Methodology Standards Checklist: (NEW) no page limit • - Applicants must complete each column of this checklist, as appropriate, and include it with the Research Plan PDF upload. 23
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