Spring 2015 Cycle: Broad PFAs Applicant Town Hall April 6, 2015 - - PowerPoint PPT Presentation
Spring 2015 Cycle: Broad PFAs Applicant Town Hall April 6, 2015 Agenda Research Plan Addressing Engagement in your application Completing other required sections of the application The Merit Review Process Questions? Ask a question via the
Applicant Town Hall
April 6, 2015
Research Plan Addressing Engagement in your application Completing other required sections of the application The Merit Review Process Questions?
Ask a question via the chat function. Ask a question via phone (an operator will standby to take your questions).
Diane E. Bild, MD, MPH Senior Program Officer, Clinical Effectiveness Research Suzanne Schrandt, JD Deputy Director, Patient Engagement Christopher Gayer, PhD Program Officer, Communication and Dissemination Research Beth Kosiak, PhD Program Officer, Improving Healthcare System Soknorntha Prum, MPH Contracts Associate Contracts Management and Administration
First things first……. Get prepared
Document
http://www.pcori.org/sites/default/files/PCORI-PFA-2015-Spring-Application-Guidelines.pdf
http://www.pcori.org/funding/opportunities
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Research Strategy
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Dissemination & Implementation Potential
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Replication & Reproducibility of Research and Data Sharing
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Protection of Human Subjects
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Consortium Contractual Arrangements
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References Cited
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Appendix
Maximum 20 pages in length Use the Research Plan Template as your guide
PLEASE provide all the information requested, as outlined in the template.
Page Limit
Two items to note:
same as in the approved LOI unless the applicant has explicit and documented approval from the program to which they will submit.
applicants should cite PCORI’s Methodology Standards.
http://www.pcori.org/assets/2013/11/PCORI-Methodology-Report.pdf
Deliverables: Measurable and verifiable
team must create and deliver according to the contract terms Milestones: Significant events or accomplishments within the project; may have deliverables associated with them
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. PCORI does not expect applicants to disseminate and implement findings at this time.
Page Limit
Describe the ability to reproduce potentially important findings from this research in other data sets and populations. Describe how you will make a complete, cleaned, de- identified copy of the final data set used in conducting the final analyses available within 90 days of the end of the final year of funding, or your data-sharing plan, including the method by which you will make this data set available, if requested. Propose a budget to cover costs of your data-sharing plan, if requested.
Page Limit
Describe the protection of human subjects who will be involved in your research. Refer to NIH standards for research involving human subjects Page Limit
Provide a Data and Safety Monitoring Plan that operates under the auspices of your institution Assure that key personnel are educated on human subjects protections Assure 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
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
Following scholarly citation practice, list the source material cited in the Research Plan. Page Limit
PCORI applications may include an appendix for additional materials the investigators think may be useful Examples of additional materials are:
– Survey instruments – Papers and publications from members of the research team;
however, reviewers will not be required to include the appendices in the review and assessment of the project
Page Limit
Inadequate support for the research question based on systematic reviews or identified gaps in clinical guidelines Studies of efficacy, not comparative effectiveness Low likelihood of study impact Limited, inappropriate, or non-specific patient-centered
Inappropriate use or explanation of usual care as a comparator
Missing key aspects of scientific design, such as well-justified power calculations Overly optimistic timeframe for enrollment Lack of support for key statements in the Research Plan Inadequately justified budgets Failure to think through complexities of recruitment and enrollment
Discuss past experiences with recruitment Provide preliminary evidence of the potential for successful recruitment Consider barriers to recruitment – and how you plan to
Strategies for successful recruitment – Engaged clinical sites – Clinician advocates for the study – Proactive, experienced research coordinator – Protocol flexibility, within reason
Potential activities include
comparators to be studied
Examples of how to demonstrate this in your proposal
that clearly describe the origin of the study topic and the role of the patient and stakeholder partners in defining the question,
Real-World Examples
helped craft the study name and materials to reduce the potential for stigma and to reframe the goal of the study as a movement toward emotional well-being rather than away from a mental health challenge.
indicated that clinical practice is quite variable and suggested that a three-arm approach would be more appropriate for the study. The study design was revised accordingly.
Potential activities
Example of how to demonstrate this in your proposal
that clearly describe the role of these partners in conducting and monitoring the study
stakeholder partners in each component of study conduct (e.g., helping draft survey tools and focus group questions, reviewing participant materials for readability), including the dissemination and implementation assessment
Real-World Examples
with patient partners to make it understandable to study participants.
through a preeclampsia advocacy group’s website and Facebook page.
should deliver the intervention, when it should be provided during the process of care, and how it should be delivered.
Potential activities include
Examples of how to demonstrate this in your proposal
partners in planning the dissemination of the study’s findings
committee that will oversee dissemination
Real-World Examples
with relevant professional societies during the third year of the study to focus on identifying ways to speed the implementation of findings into practice.
patient advocacy conference to inform the community that this research was ongoing and to stay tuned for future results.
Six Engagement Principles
Real-World Examples
partners
and stakeholder partners
times and locations
Several approaches to engagement can succeed PCORI provides many engagement resources: – PCORI’s “Engagement Rubric”
http://www.pcori.org/sites/default/files/PCORI-Engagement-Rubric-with-Table.pdf
– Sample Engagement Plans
http://www.pcori.org/sites/default/files/announcement-resources/PCORI-Sample- Engagement-Plans.pdf
– Engagement in Research website page
http://www.pcori.org/content/engagement-research
– PCORI’s Methodology Standards PC-1 to PC-4
http://www.pcori.org/assets/PCORI-Methodology-Standards1.pdf
► PI and Contact Information ► Project Information ► Key Personnel ► Milestones ► Templates and Uploads
Public Abstract
Technical Abstract Project Narratives
► PI and Contact Information ► Project Information ► Key Personnel ► Milestones ► Templates and Uploads ► Save and Review
► PI and Contact Information ► Project Information ► Key Personnel ► Milestones ► Templates and Uploads ► Save and Review
► PI and Contact Information ► Project Information ► Key Personnel ► Milestones ► Templates and Uploads ► Save and Review
Per person
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 Limit
Professional Profile/Biosketch
Detailed Budget Budget Summary Budget Justification NOTE:
A detailed budget is needed for each year of the
prime applicant and any/each subcontractor.
Personnel Consultant Equipment Supplies Travel Other Expenses Consortium/Contractual Direct Costs Prime Indirect Costs Prime Direct Costs
Narrative that fully supports and explains the basis for the information in the Budget Detail – Provide sufficient detail to understand the basis for costs, the reason that the costs are necessary, and an explanation for major cost variances – Use the budget template to tell PCORI why the costs are reasonable for the work to be performed Breakdown of costs proposed for each consortia or contractor Must specify any other sources of funding that are anticipated to support the proposed research project Provide quotes, indirect cost rate letter, fringe benefit policy
All letters of support should be addressed to the PI to 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
Letters of support should be organized in the following manner:
resources
Using the wrong browser, access PCORI Online via Chrome or Safari browsers Not entering information into all required fields in the system 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
Refer to the funding opportunities page in our Funding Center (http://www.pcori.org/funding/opportunities) for the following resources:
PFA and Application Guidelines Sample Engagement Plans Applicant Training: http://trainings.pcori.org/applicationtrainingspring2015/story.html General Applicant FAQs: http://bit.ly/applicant_faqs PCORI Online: https://pcori.fluxx.io/ Research Methodology: http://www.pcori.org/node/4020
Applicants must follow administrative requirements set in PCORI’s Application Guidelines.
► Exceeding page limits, budget, or time limitations ► Not using PCORI’s required templates ► Submitting incomplete sections or applications
Missing the Mark
Impact of the condition on the health of individuals/populations Potential for the study to improve healthcare and outcomes Technical merit Patient-centeredness Patient and stakeholder engagement
by a panel of two scientists, one patient, and one other stakeholder.
Governors makes funding decisions based on merit review and staff recommendations.
Is the condition or disease associated with a significant burden in the US population, in terms of prevalence, mortality, morbidity, individual suffering,
Alternatively, does the condition or disease impose a significant burden on a smaller number of people who have a rare disease? Does the proposal include a particular emphasis on patients with one or more chronic condition?
Does the research question address a critical gap in current knowledge as noted in systematic reviews, guideline development efforts, or previous research prioritizations? Has it been identified as important by patient, caregiver, or clinician groups? Do wide variations in practice patterns suggest current clinical uncertainty? Is the research novel or innovative in its methods or approach, in the population being studied, or in the intervention being evaluated in ways that make it likely to improve care? Do preliminary studies indicate potential for a sizeable benefit of the intervention relative to current practice? How likely is it that positive findings could be disseminated and implemented quickly, resulting in improvements in practice and patient outcomes?
Does the proposal delineate a clear conceptual framework/theory/model that anchors the background literature and informs the design, key variables, and relationships being tested? Are the comparison interventions realistic options that exist in current practice? Are sample size and power estimates presented that are based on realistic and careful evaluations of the anticipated effect size? Is the project timeline realistic, including specific scientific and engagement milestones? Does the research team have the necessary expertise to conduct the project? Is the organizational structure and are the described resources appropriate to carry out the project? Is there a diverse study population with respect to age, gender, race, ethnicity, and clinical status, appropriate for the proposed research?
Is the research focused on questions that affect outcomes of interest to patients and their caregivers? Does the research address one or more of the key questions mentioned in PCORI’s definition of patient-centered outcomes research?
– “Given my personal characteristics, conditions, and preferences, what should I expect will happen to me?” – “What are my options, and what are the potential benefits and harms of those
– “What can I do to improve the outcomes that are most important to me?” – “How can clinicians and the care delivery systems they work in help me make the best decisions about my health and health care?”
Are patients and stakeholders engaged in:
cares about (e.g., survival function, symptoms, health-related quality of life) and that inform decision making relevant to the research topic
Are the roles and the decision making authority of all research partners clearly stated? Does the proposal demonstrate the principles of reciprocal relationships, co-learning, partnership, trust, transparency, and honesty?
Preliminary review In-Person review Post-Panel review
For Programmatic Inquiries… Phone: 202.627.1884 Email: sciencequestions@pcori.org For Administrative/Technical Inquiries… Phone: 202.627.1885 Email: pfa@pcori.org