Cycle 3 2015: Targeted Funding Announcement Applicant Town Hall • Management Strategies for • Treatment of Multiple Sclerosis Treatment-Resistant Depression • New Oral Anticoagulants (NOACs) • Clinical Strategies for Managing and in the Extended Treatment of Reducing Long-Term Opioid Use for Venous Thromboembolic Disease Chronic Pain January 20, 2016
Agenda Application Requirements Patient Engagement Budget 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).
Today’s Presenters Allison Ambrosio, MPH Suzanne Schrandt, JD Maricon Gardner, CRA Carolyn Mohan, DrPH, Program Associate Associate Deputy Director MPH, MIA Clinical Effectiveness Research Patient Engagement Contracts Operations Merit Review Officer Julie McCormack, MA Diane Bild, MD, MPH Layla Lavasani, PhD, MHS Program Officer Senior Program Officer Program Officer Clinical Effectiveness Research Clinical Effectiveness Research Clinical Effectiveness Research
Your letter of intent (LOI) was reviewed and you have been invited to submit a full application. CONGRATULATIONS!
LOI Changes • You were invited to submit a full application based on the information you provided in the LOI • Please contact PCORI (pfa@pcori.org) if you wish to make any significant changes to the proposed study including the following: – PI – Institution – Study design – Budget or period of performance – Research question – Aims – Comparators • PCORI must approve any changes before the full application is submitted
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 • Carefully consider the feedback you received on your LOI 7
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
Research Strategy: Overview Maximum 20 pages in length Use the Research Plan Template as your guide - Background - Significance - Patient Population - Recruitment Plan - Estimated Racial/Ethnic and Gender Enrollment Table - Study Design or Approach - Engagement Plan - Research Team and Environment PLEASE provide all the information requested, as outlined in the template. Page Limit 20 9
Research Strategy: Recruitment Plan Discuss past experiences with recruitment of the target population Provide preliminary evidence of the potential for successful recruitment Provide numbers for the pool of potential participants, those estimated to be eligible, and the expected participation rate Discuss barriers to recruitment and how you plan to overcome them Strategies for successful recruitment – Engaged clinical sites – Clinical advocates – Proactive, experienced research coordinator – Alignment and integration of recruitment activities with clinical workflow
Research Strategy: Study Design/Approach Tips Document how proposed study will fill the evidence gap Document efficacy/effectiveness and/or frequency in clinical practice Provide a clear research plan with rigorous methods that adhere to PCORI’s Methodology Standards and accepted best practices A clear justification for the study design and outcome measures Clearly described and justified comparators Sample sizes and power estimates based on careful evaluations of the anticipated effect size Feasibility Realistic strategies for participant recruitment and retention
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 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: 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
Research Plan Template: Protection of Human Subjects • 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 participant s – 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 Page subjects 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
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
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.
Use of FDA-Regulated Medical Products All drugs, biologics, devices, and diagnostics used in your study must be FDA-approved • Indicate within your application whether investigational new drug (IND) or other regulatory approval will be needed to conduct your study For example, if your study administers an approved medical product in an off-label manner (e.g., a dose, route, frequency, indication, or patient population that is unapproved by FDA) you may need an IND • If uncertain, seek guidance from FDA or your legal counsel
Engagement
Patient-Centeredness Is the research focused on questions that affect outcomes of interest to patient and their caregivers? Does the research question address choices that are important to - and faced frequently by - patients, their caregivers, or clinicians? Is the study powered on outcomes that are important to patients? Are the interventions being compared in the study available to patients now?
Addressing Patient-Centeredness Provide evidence that the research question(s) and outcomes are important to patients (and/or their caregivers) Describe your strategy for measuring outcomes that are important to patients. Remember that a study can be patient-centered even if the end-user is not the patient, as long as patients will benefit from its information. If the end-user is not the patient, be sure to carefully describe how your study is still patient-centered.
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