Partnerships To Conduct Research (PaCR) within PCORnet: Applicant Town Hall Maryan Zirkle, MD, MS, MA Senior Program Officer, Research Infrastructure Mekia Winder, MPH Administrator, Contracts Operations Nora McGhee, PhD Senior Merit Review Officer, Office of the Chief Science Officer August 23, 2017 1
Agenda Programmatic Overview Submitting Questions: Letters of Intent and Full Application Submit questions via the chat function in GoToWebinar. Merit Review Administrative Requirements Resources/FAQs
PaCR: Overview • Objective – This 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: – Generate CER evidence relevant to specific conditions, treatments, and patient communities or more generally to clinical care for broader populations; – Support PCORnet sustainability by attracting collaboration and support from non-PCORI funders in CER research; – Develop data linkages between patient data and data from electronic health records, claims data and/or disease-specific registries. 3
PaCR: Eligibility and Budget • PCORI seeks to fund 3 – 5 high-quality clinical studies to answer important patient- and stakeholder-prioritized comparative clinical effectiveness research (CER) questions that remain unanswered due to insufficient or inconclusive evidence. – PCORI is soliciting applications only from PPRNs currently funded under the Phase II PCORnet award. – Each PPRN is eligible to submit one LOI. Project Budget: Up to $15 million in direct costs Project Budget: Up to $15 million in direct costs to fund up to five projects; up to $5 million per to fund up to five projects; up to $5 million per project project Project period: Maximum of 3 years Project period: Maximum of 3 years 4
PaCR: Specific Requirements • Partner Funding: – Applicants will be required to secure partner funding (which may include in- kind resources) and support from industry and/or organizational collaborators prior to submitting the full application. • Application will need to provide strong, convincing letters of collaboration from collaborating funders. • Data Linkages: – Linkages between patient data and EHR/clinical data (CDRNs), claims data and/or with data from a disease-specific registry. • Stakeholder-driven Priority Topic: – Applications must address stakeholder-driven priority topic areas with a CER question related to a rare or common condition. 5
PaCR: Leveraging Existing Resources • PCORnet Infrastructure: – Coordinating Center – Collaborative Research Groups (CRGs) – Streamlined IRBs, contracting, engagement, and consenting processes – PCORnet’s Common Data Model (CDM), where applicable – The Commons • Comprehensive and Complete Data: – Specific PPRN and other PPRNs – CDRNs – Data sources other than PCORnet – Registries – Health Plans – CMS 6
Letters of Intent (LOI) Letters of Intent (LOI)
(PaCR) – LOI Submission System Webinar PCORI is offering a system-based webinar for Cycle 2 2017 Partnerships to Conduct Research within PCORnet (PaCR) applicants submitting a Letter of Intent (LOI) through the new PCORI Online. • This webinar will cover the following processes: • Navigate PCORI Online • Update an LOI in Progress • Submit and LOI for PCORI Review Monday, August 28, 2017 - 01:00 pm to 02:00 pm ET Register at: http://www.pcori.org/events/2017/partnerships-conduct-research-within- pcornet-pacr-%E2%80%93-loi-submission-system-webinar 8
Letters of Intent (LOIs) • The Patient-Centered Outcomes Research Institute (PCORI) will screen Letters of Intent (LOIs) for responsiveness to this PCORI Funding Announcement (PFA) and for fit to program goals – PCORI will invite applicants whose LOIs are most responsive to this PFA and to the criteria to submit a full application – Only those applicants selected may submit full applications Due Date for LOI Submission: September 6, 2017 by 5 p.m. ET 9
Letters of Intent (LOIs) • LOI Review will be based on the following criteria: – Importance of the research question to current clinical decision making, as evidenced by critical gaps identified by clinical guidelines developers or recent relevant systematic reviews – Study scope sufficient to have a significant impact on patient outcomes or healthcare practices – Clarity and credibility of applicants’ responses to the LOI questions— including the rationale for the estimated sample size (i.e., citing published estimates, including effect sizes, standard deviations, and the need for rigorous comparative analysis of important subgroups); proposed partnerships and the anticipated level of partner-funding supporting the project; plans for advancing data integration; and use and enhancement of existing PCORnet infrastructure resources • Adherence to the administrative and formatting requirements listed in the Application Guidelines — THREE PAGE LIMIT FOR THE LOI Notification of denial or approval to submit a full application will occur no later than September 26, 2017. 10
Full Applications 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 CDRNs, PPRNs, Health Plans Research Networks (HPRNs), their affiliated study performance sites, and PCORnet Collaborative Research Groups (CRGs) that will be collaborating on the project. Also, describe how you will minimize risk to the proposed study throughout the performance period after PCORnet Phase II infrastructure funding (to participating CDRNs, PPRNs, HPRNs, and/or CRGs) ends. – 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 across proposed study sites, research consortia, and/or other collaborating organizations and whether you will use any dedicated data-coordinating functions or facilities. When feasible and relevant, the PCORnet Coordinating Center should meet data coordination needs. 12
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 • Research questions and outcomes reflect what is important to patients and caregivers and consider patient preferences Patient Engagement • Project includes active engagement among scientists, patients and stakeholders • 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
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