Partnerships to Conduct Research within PCORnet (PaCR): Applicant Town Hall Kimberly Marschhauser, PhD Program Officer Angela Hvitved, PhD Merit Review Officer Rhonda Stewart Contract Administrator Jason Gerson, PhD Senior Program Officer
Agenda Programmatic Overview Submitting Questions Letters of Intent and Full Application Submit questions via the chat function Merit Review in GoToWebinar Administrative Requirements Data Management and Data-Sharing Resources/FAQs 2
Programmatic Overview Kim Marschhauser, PhD
PaCR: Overview Objective: • • This limited funding opportunity is the next step in PCORI’s intentional strategy to achieve the Board’s vision of a sustainable national research infrastructure that attracts a diverse set of public and private funders of research Aims: • • To promote PCORnet sustainability through collaboration and engagement with non- PCORI co-funders in the conduct of clinical comparative effectiveness research (CER) • To promote greater completeness of PCORnet data through linkages of electronic data with that of health plans, disease registries, and other complementary data sources 4
Eligibility and Budget PCORI seeks to fund up to two high-quality clinical studies to answer important patient • and stakeholder-prioritized CER questions PCORI is soliciting applications from Clinical Research Networks (CRNs) or Health Plan • Research Networks (HPRNs) continuing to be funded as part of PCORnet 2.0 Each CRN or HPRN is eligible to submit one LOI • Project Budget: • Up to $2 million in direct costs • Up to $6 million in total costs Project period: Maximum of 3 yearsars
Specific Requirements Partner Funding : • • Applicants will be required to secure 50% partner funding (which may include in-kind resources) from federal, industry, and other nonfederal co-funders (e.g., health plans, health systems, advocacy organizations) prior to submitting the full application • Letters of Support: • Applications need to provide strong, convincing letters of support from co-funders (due with the full application) • Demonstrate a clear understanding of the project and a detailed description of the contributions in terms of funding and in-kind services • Co-funding partnerships must demonstrate potential for additional future partnerships/collaboration with PCORnet 6
Specific Requirements Data Linkages : • • Promote greater completeness of PCORnet data through linkages of EHR/clinical data with claims data, disease registry, or other complementary data source • Applicant CRNs and HPRNs are required to use the PCORnet 2.0 Common Data Linkage Method , if available Stakeholder-driven Priority Topic: • • Applications must address stakeholder-driven priority topic area with a CER question 7
Leveraging Existing Resources PCORnet Infrastructure Comprehensive and Complete Data • Coordinating Center • CRNs • Collaborative Research Groups (CRGs) • Data sources other than PCORnet • Streamlined IRBs, contracting, • Registries engagement, and consenting processes • Health Plans • PCORnet’s Common Data Model (CDM), • CMS where applicable • PPRNs • The Commons 8
Letters of Intent
Noncompetitive Letters of Intent (LOIs) Submission of a noncompetitive LOI is required for this PCORI Funding Announcement • A Letter of Support from the PCORnet 2.0 Steering Committee is required with the LOI • submission While LOIs will not be competitively screened, all information outlined in the PFA's LOI • template is required A Principle Investigator (PI) can submit only one LOI • Each CRN or HPRN may be the lead PCORnet affiliation for one LOI • Due Date for LOI Submission: May 13, 2019 by 5 p.m. ET 10
Full Applications
Development of the Research Strategy Complete guidance can be found in the PFA and in the Research Plan Template. The following • are key pieces to keep in mind during Research Strategy development: • Identify and justify all participating research network entities (e.g., health plans, consortia projects, disease registries, etc.). For PCORnet, identify the names of participating CRNs, PPRNs (if appropriate), HPRNs, their affiliated study performance sites, and PCORnet Collaborative Research Groups (CRGs) that will be collaborating on the project • Demonstrate that the proposed data source(s) can comprehensively capture the study variables needed to assess the interventions, covariates, and outcomes • Describe how you will link and manage data using the PCORnet Common Data Linkage Method (if available) across proposed study sites, research consortia, and/or other collaborating organizations and whether you will use any dedicated data-coordinating functions or facilities
Research Team and Environment Complete guidance can be found in the PFA and in the Research Plan Template. The following are • key pieces to keep in mind during Research Team and Environment development: • 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 • How and why each research site was selected and how those sites tie back to the research project • If multiple sites are involved, prior experience that demonstrates the likelihood of working together successfully (e.g., past data sharing, IRB reciprocity, or other factors) to facilitate efficient conduct of the study • How sites will work together to ensure that milestones will be achieved • Logistical support , such as administrative management and oversight, and best practices training 13
Patient-Centeredness and Patient Engagement Patient-Centeredness Patient Engagement • Research questions and outcomes • Project includes active reflect what is important to engagement among scientists, patients and caregivers and patients, and stakeholders consider patient preferences • Projects includes community, patient and caregiver involvement 14
Dissemination and Implementation Potential Complete guidance can be found in the Application Guidelines and in the Research Plan • Template. The following are key pieces to keep in mind during Dissemination and Implementation Potential development: • Identify who will make decisions or use the findings produced by this study, such as local and national stakeholders • Describe a plan for disseminating study findings outside of PCORnet beyond publication in peer-review journals and at national conferences • Present a credible plan through which findings could be feasibly disseminated and implemented quickly within PCORnet (including at the local hospital or clinic level and at the leadership level including health systems leaders and clinical leaders), resulting in improvements in healthcare system, practice and patient outcomes • Clearly outline the roles of patient and stakeholder partners (including health systems leaders and clinical leaders) in the planning of disseminating the study’s findings 15
Consortium Contractual Agreements Complete guidance can be found in the Application Guidelines and in the Research • Plan Template. The following are key pieces to keep in mind during Consortium and Contractual Agreements development: • Describe the proposed research projects that subcontracted organizations will perform : Explain the strengths that these partners bring to the overall project to ensure successful submission of contract deliverables in accordance with the milestone schedule • The prime applicant is responsible for the project and must adhere to the contract’s terms and conditions. The prime applicant should negotiate his or her subcontracts accordingly • PCORI does not require signed subcontract agreements at the time of application submission 16
Merit Review Angela Hvitved, PhD 17
What happens to your application after you submit it?
Administrative Screening Applicants must follow the administrative requirements stated in PCORI’s Application Guidelines. Applications may be administratively withdrawn for the following reasons: • Exceeding budget or time limitations • Not using PCORI’s required templates • Submitting incomplete sections or applications 19
Programmatic Screening Applications may be programmatically withdrawn for the following reasons: • Inclusion of cost-effectiveness analysis (CEA) • Inclusion of development and dissemination of clinical practice guidelines (CPG) • Not responsive to the program-specific PFA 20
Merit Review Process pcori.org/content/merit-review-process 21
Application Review Applications are reviewed against six criteria: 1. Potential for the study to fill critical gaps ▪ Each application is reviewed by in evidence three scientists, one patient, and 2. Potential for study findings to be adopted one other stakeholder. into clinical practice and improve delivery ▪ PCORI’s Board of Governors of care makes funding decisions based 3. Scientific merit (research design, analysis, on merit review and staff data linkages, and outcomes) recommendations. 4. Investigator(s) and environment 5. Patient-centeredness 6. Patient and stakeholder engagement 22
Administrative Requirements Rhonda Stewart 23
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