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 chat function. Ask a question via phone (an operator will standby to take your questions).
Today’s Presenters Diane E. Bild, MD, MPH Christopher Gayer, PhD Beth Kosiak, PhD Senior Program Officer, Program Officer, Communication Program Officer, Clinical Effectiveness Research and Dissemination Research Improving Healthcare System Soknorntha Prum, MPH Suzanne Schrandt, JD Contracts Associate Deputy Director, Contracts Management Patient Engagement and Administration
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 to Changes to Changes to Changes in the the Study the PI Engagement Institution Design
Preparing your application for submission First things first……. Get prepared - Read and review the PCORI Application Guidelines Document http://www.pcori.org/sites/default/files/PCORI-PFA-2015-Spring-Application-Guidelines.pdf - Re-read the funding announcement for which you are applying http://www.pcori.org/funding/opportunities - Review the PCORI Research Plan Template - Have a copy of your approved LOI readily accessible
Research Plan Template Research Strategy ► Dissemination & Implementation Potential ► Replication & Reproducibility of Research and ► Data Sharing Protection of Human Subjects ► Consortium Contractual Arrangements ► References Cited ► Appendix ►
Research Strategy Maximum 20 pages in length Use the Research Plan Template as your guide - Background - Significance - Study Design/Approach - Project Milestones/Timeline - 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
Research Strategy Two items to note: - Research questions and specific aims MUST be the same as in the approved LOI unless the applicant has explicit and documented approval from the program to which they will submit. - While completing the study design/approach section, applicants should cite PCORI’s Methodology Standards. http://www.pcori.org/assets/2013/11/PCORI-Methodology-Report.pdf
PCORI Monitors Projects 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
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. PCORI does not expect applicants to disseminate and implement findings at this time. Page Limit 2
Replication & Reproducibility of Research and Data Sharing 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 2
Protection of Human Subjects Describe the protection of human subjects who will be involved in your research. Refer to NIH standards for research involving human subjects Page Limit 5
Study Participant Protection 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
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
References Cited Following scholarly citation practice, list the source material cited in the Research Plan. Page Limit 10
Appendix 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 10
Application Common Mistakes 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 outcomes Inappropriate use or explanation of usual care as a comparator
Application Common Mistakes 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
Recruitment Discuss past experiences with recruitment Provide preliminary evidence of the potential for successful recruitment Consider barriers to recruitment – and how you plan to overcome them Strategies for successful recruitment – Engaged clinical sites – Clinician advocates for the study – Proactive, experienced research coordinator – Protocol flexibility, within reason
Addressing engagement in your application
The Engagement Rubric Planning the Study Conducting the Study Disseminating the Study Results PCOR Engagement Principles
Planning the Study Potential activities include - Identifying the topic and developing the research question and comparators to be studied - Defining the characteristics of study participants Examples of how to demonstrate this in your proposal - Providing letters of support from patient and stakeholder partners that clearly describe the origin of the study topic and the role of the patient and stakeholder partners in defining the question, outcomes, comparators, goals and outcomes, and so on
Planning the Study (Cont’d.) Real-World Examples - Mental health study: Patient partners and community members 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. - Diabetes study: Clinicians who reviewed the initial study design 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.
Conducting the Study Potential activities - Drafting or revising study materials and protocols - Assisting with the recruitment of study participants Example of how to demonstrate this in your proposal - Providing letters of support from patient and stakeholder partners that clearly describe the role of these partners in conducting and monitoring the study - Clearly articulating in the application the roles of the patient and 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
Conducting the Study (Cont’d.) Real-World Examples - Chronic pain study: The informed consent document was developed with patient partners to make it understandable to study participants. - Preeclampsia study: The study team is recruiting via a national network of local health departments and community health centers, as well as through a preeclampsia advocacy group’s website and Facebook page . - Asthma study: Clinicians and patients both provided guidance on who should deliver the intervention, when it should be provided during the process of care, and how it should be delivered.
Dissemination the Study Results Potential activities include - Identifying partner organizations for dissemination - Planning dissemination efforts Examples of how to demonstrate this in your proposal - Clearly identifying the role of patient and stakeholder partners in planning the dissemination of the study’s findings - Including patient and stakeholder partners on a project committee that will oversee dissemination
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