Broad PCORI Funding Announcement Applicant Town Hall Cycle 3 2016 November 2, 2016
Agenda Research Strategy Patient Engagement and Engagement Plan Additional sections required for your application The Merit Review Process Questions Submit questions via the chat function in Meeting Submitting Questions: Bridge. Ask a question via phone (an operator will standby to take your questions).
Introductions Greg Martin Gyasi-Moscou- Jackson, PhD, MHS, RN Mira Greiser, MHS Deputy, Chief Engagement Program Officer Program Officer and Dissemination Officer Improving Healthcare Systems Addressing Disparities Lauren Massey Mari Kimura, PhD William Lawrence, MD, MS Contracts Associate Merit Review Officer Senior Program Officer, Contracts Management and Merit Review Communication and Administration Dissemination Research
Your letter of intent (LOI) was reviewed and you have been invited to submit a full application CONGRATULATIONS!
Letter of Intent and Application You were invited to submit a full application based on the information provided in the LOI; changes after the LOI require PCORI approval. Show stoppers include: Changes Changes to Changes Changes Changes to Changes to the the Budget/ to Changes to to the Research to the PI Study Period of Specific Comparators Institution Question Design Performance Aim
Application Requirements
Preparing Your Application • To begin, all applicants should: • Read the funding announcement and review the PCORI Application Guidelines Document • Review the PCORI Research Plan Template • Have a copy of your approved LOI readily accessible • Review PCORI feedback on your LOI 7
Tips for Success • Clearly describe comparators for the study • Document evidence of efficacy/effectiveness for the intervention and comparator(s) and/or demonstrate that they are in widespread use • Provide a sound rationale for why the research question of interest is important to patients • Clearly demonstrate the feasibility of the study – Show that you have the team to do this and you are the right team – Define and support your recruitment and retention plan – Document that sites are already committed to participating – Include realistic timelines for site start-up, IRB approval, and recruitment
Research Strategy: Overview Use the Research Plan Template as your guide - Background - Significance - Study Design or Approach - Specific Aims - Methods - Patient Population - Recruitment Plan - Estimated Racial/Ethnic and Gender Enrollment Table - Research Team and Environment - Engagement Plan PLEASE provide all the information requested, as outlined in the template. Page Limit 20 9
Research Strategy: Study Design/Approach Document how proposed study will fill the evidence gap Include a clear conceptual framework, theory or model that anchors the background, significance, and informs the design, key variables, and relationships being tested Clearly describe and justify comparators, including usual care. Document efficacy/effectiveness and/or frequency of proposed comparator(s) in clinical practice Provide clear justification for the study design and outcome measures. Include clear rationale for sample size, power estimates, effect sizes and support rationale with evidence or pilot work Demonstrate that your study is feasible by outlining realistic strategies for participant recruitment and retention or by providing preliminary data analysis for observational approaches
Research Strategy: Methodology Standards In any study, methods are critical. PCORI’s Methodology Committee developed Methodology Standards to which patient- centered CER must adhere Methodology Standards: 11 Specific Categories • Formulating Research • Data Networks Questions • Data Registries • Patient-Centeredness • Adaptive and Bayesian • Data Integrity and Rigorous Trial Designs Analyses • Causal Inference • Preventing/Handling Missing • Studies of Diagnostic Data Tests • Heterogeneity of Treatment • Systematic Reviews Effects
Research Strategy: Patient Population and Recruitment Provide numbers for the pool of potential participants, those estimated to be eligible, and the expected participation rate 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 Complete Recruitment Plan for Prospective Studies table Complete Estimated Racial/Ethnic and Gender Enrollment table
Research Strategy: Engagement Plan Describe the plan to engage patients and stakeholders meaningfully in the various phases of the proposed research Planning the study Designing the study Conducting the study Evaluating the study
Research Plan Template: Dissemination & Implementation Potential Describe the potential for disseminating and implementing the results of this research in other settings Describe possible barriers to disseminating and implementing the results of this research in other settings Describe how you will make study results available to study participants after you complete your analyses Page PCORI does not expect applicants to disseminate and Limit implement findings at this time 2
Research Plan Template: Protection of Human Subjects Provide a Data and Safety Monitoring Plan that operates under the auspices of your institution Ensure that key personnel are trained on human subjects protections Ensure appropriate informed consent Establish procedures to minimize risks to participants Establish procedures to protect privacy and maintain confidentiality If you anticipate seeking waiver of individual informed consent, provide the rationale Refer to NIH standards for research involving human subjects Page Limit 5
Research Plan Template: Consortium Contractual Arrangement Describe the proposed research projects that will be performed by subcontracted organizations Explain the strengths that these partners bring to the overall project Page Limit 5
Research Plan Template: References Cited Following scholarly citation practice, list the source material cited in the Research Plan. Page Limit 10
Research Plan Template: Appendix • PCORI applications may include an appendix for additional materials the investigators think may be useful – Reviewers will not be required to include the appendices in the review and assessment of the project • Examples of additional materials are: – Survey instruments – Papers and publications Page Limit 10
Milestones/Deliverables Template Milestones: Significant events or accomplishments within the project; may have deliverables associated with them Deliverables: Measurable and verifiable outcomes or objects that a project team must create and deliver according to the contract terms
Example of Milestone Schedule
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 Page Professional Limit Profile/Biosketch 15
Leadership Plan Template ( Dual PI application) Describe the governance and organizational structure of the leadership team and the research project Delineate the administrative, technical, scientific, and engagement responsibilities for each PI and the rationale for submitting a dual-PI application Discuss communication plans and the process for making decisions on scientific and engagement direction Page Describe the procedure for resolving conflicts Limit 5
Letters of Support • Save all letters of support as single PDF file prior to uploading to the PCORI Online System • All letters of support should be addressed to the PI and demonstrate the commitment of key personnel and supporting organizations to your proposed project • Letters of support should clearly reflect the substantive involvement and material contribution to be provided by the signatory parties, and are meant to substantiate the commitment of collaboration of all forms • Each letter of support should be unique
Reminders: Tips for Success • Clearly describe comparators for the study including a comprehensive description of the established efficacy/effectiveness and/or widespread use • Clearly demonstrate the feasibility of the study – You have the team to do this and you are the right team – Recruitment goals are realistic • Time allotted for recruitment should be realistic • Successful recruitment strategies must be highlighted – Research sites are already committed to participating • Realistic about length of time it will take to get IRB at all participating sites • Provide a sound rationale for why the research question of interest is important to patients
Questions related to the research plan
Engagement
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