Patient-Powered Research Network (PPRN) Research Demonstration Project: A Cross-PPRN Opportunity Applicant Town Hall Rachel Rath, MPH Senior Program Associate, CER Methods and Infrastructure Ashton Ferrara Specialist, Contracts Operations February 1, 2016
Agenda Submitting Questions: Programmatic Overview Submit questions via the chat function in Meeting Bridge. Administrative Requirements Ask a question via phone Questions and Answers (an operator will standby to take your questions).
Programmatic Overview Rachel Rath, MPH Senior Program Associate, CER Methods and Infrastructure February 1, 2016 << Develop infrastructure for D&I >>
Overview The PPRNs have a unique opportunity to broaden the scope of their research to include topics that are meaningful to all patients. This Cross-PPRN PFA seeks to fund a comparative clinical and/or health care services question that reflects shared information needs and decisional uncertainties commonly faced by the collaborating PPRN communities. 3 collaborating PPRNs must be included to demonstrate scientific, operational, and logistical capacity to collaborate across PPRNs. PCORI will fund up to one cross-PPRN research project. Project Budget: Up to $4 million in total costs Project period: Maximum of 3 years
Objectives of this PFA There are three main objectives: 1. Relevance: support research on a comparative clinical and/or health services research question that was generated and prioritized by the participating PCORnet PPRNs and remains unanswered due to insufficient or inconclusive evidence 2. Collaboration: Develop efficient processes that demonstrate collaborative research capacity across PPRN networks. Use, develop, and contribute to PCORnet’s shared tools and resources (The PCORnet Commons) to accelerate the conduct of research using PCORnet 3. Evaluation: Formally test and evaluate the impact of the research project on PCORnet’s capacity to support collaborative research and extend the breadth of PCORnet Commons
Relevance of Research Question Provide specific evidence that collaborating PPRNs and patients participated in the generation and prioritization of the research question Research question addresses shared evidence gap and has capacity to impact patient outcomes across PPRN communities Describe the process for PPRNs to add PPRN specific outcomes and describe any mechanism for oversight or standardization of these additional outcomes of interest
Development of the Research Plan Provide specific evidence that collaborating PPRNs and patients participated in the development of the research plan Justify the suitability of research design and a detailed description of study comparators Identify how data elements from CDM v3.0 will be used Provide a detailed description of the inclusion/exclusion criteria Demonstrate commitment to the use of a centralized or single IRB Provide sufficient justification related to sample size, power, and effect size
Collaboration Encourage collaboration between as many PPRNs, as appropriate for research question, but require a minimum of at least 3 collaborating PPRNs Expect collaboration to support the conduct of the research and the development of PCORnet tools and resources Provide a rationale for meaningful partnerships selected and a clear justification for the collective capacity to address the research question - Clarify any collaboration that will occur with the PCORnet Coordinating Center and other key stakeholders
Evaluation Plan A primary aim of the demonstration projects is to test, evaluate, and report on PCORnet’s collaborative infrastructure Applications should include a clear and detailed evaluation plan and timeline to assess the impact of all project aims on - Strengthening PCORnet’s capacity to conduct collaborative research - Enhancing the PCORnet Commons through collaborative efforts that result in meeting technical assistance needs and developing scalable resources Provide details on the distribution of evaluative aspects of the study (i.e. surveys) Applicants should consider including the following aspects in the scope of the evaluation: - Feasibility of recruitment practices - Technical infrastructure - Capacity and utility of co-enrollment - Accessibility of the study portal - Operational and administrative simplicity - Data quality in the scope of the evaluation Results from evaluation will be described in an interim report to PCORI (end of first year) and summarized in a final report at the end of the project
Selection of Principal Investigators Each application must be lead by at least two PIs Lead PI must be from the applicant PPRN Other co-PIs may be from other PPRNs Application should provide evidence of the capacity of the proposed Coordinating Center to support the study. The PIs should follow the designations below: ► PI representing patients, caregivers, or the community ► PI representing researchers or clinicians
Criterion for Merit Review Criterion 1. Potential for study to improve health care and outcomes - Was the research question generated and prioritized by the PCORnet PPRN community and their patients/participants? - Does the applicant present a credible plan by which findings could rapidly be disseminated and implemented, resulting in improvements in practice and patient outcomes? Criterion 2. Technical merit - Are each of the comparators clearly described and well justified? - Are the sample sizes and power estimates presented based on realistic and careful evaluations? Is the effect size adequately justified? Criterion 3. Patient-centeredness - Does the application include a thorough description about which outcomes (both benefits and harms) are important to patients? Criterion 4. Patient and stakeholder engagement - Does the application show evidence of active engagement among scientists, patients, and other stakeholders throughout the entire research process?
Administrative Requirements
Preparing your application for submission – Getting Prepared - Re-read the funding announcement for which you are applying - http://www.pcori.org/funding-opportunities/announcement/patient- powered-research-network-pprn-research-demonstration - Have a copy of your approved LOI readily accessible and any feedback that was provided by the program - Review the PCORI Research Plan Template
Research Plan Template Research Strategy ► Engagement Plan ► Evaluation Plan ► Dissemination & Implementation Potential ► Replication & Reproducibility of Research and Data ► Sharing Protection of Human Subjects ► Consortium Contractual Arrangements ► References Cited ► Appendix ►
Research Strategy Maximum 15 pages in length Use the Research Plan Template as your guide - Background - Significance - Study Design or Approach - Patient Population - Recruitment Plan - Estimated Racial/Ethnic and Gender Enrollment Table - Research Team and Environment PLEASE provide all the information requested, as outlined in the template. Page Limit 15
Research Template – Page limits Engagement Plan – 3 pages Evaluation Plan – 3 pages Dissemination and Implementation Potential – 2 pages Replication and Reproducibility of Research and Data Sharing – 2 pages Protection of Human Subjects – 5 pages Consortium Contractual Arrangements – no limit References Cited – 10 pages Appendix (Optional) – 10 pages
PCORI Online: Application ► PI and Contact Information ► Project Information ► Key Personnel ► Milestones ► Templates and Uploads ► Save and Review
SUBMITTING AN APPLICATION Start early! Download the PFA-specific Research Plan T emplate, found on the Funding Opportunities page on PCORI website. Go into PCORI Online, use Chrome or Safari browsers to access the system. DUE DATE FOR APPLICATION: MARCH 17, 2016 –BY 5:00 P .M. (ET)
SUBMITTING AN APPLICATION Complete the required fields and upload the required documents: Research Plan Template – Note Page limits as outlined in the Template People and Places Template Budget Template Letters of Support DUE DA TE FOR APPLICATION: MARCH 17, 2016 BY 5:00 P .M. ET
People and Places Template: Biosketch You may use the NIH biosketch or PCORI’s format Biosketches are required for all key personnel List all partners within the Key Personnel section Patient/Stakeholder Biosketch Page Limit 5 Per person
People and Places Template: Project / Performance Site(s) Demonstrate that the proposed facilities have the appropriate resources required to conduct the project to plan, within budget, and on time. Provide a description of the facilities that will be used during the project, including capacity, capability, characteristics, proximity, and availability to the project. Professional Profile/Biosketch
Budget Templates 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 project. Complete each budget section for the NOTE: prime applicant and any/each subcontractor.
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