Patient-Powered Research Network (PPRN) Research Demonstration - - PowerPoint PPT Presentation

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:

Submit questions via the chat function in Meeting Bridge. Ask a question via phone (an operator will standby to take your questions).

Programmatic Overview Administrative Requirements Questions and Answers

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,

• perational, 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

• utcomes 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

• utcomes?

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 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 Plan Template

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

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

SUBMITTING AN APPLICATION

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:

Detailed Budget Budget Summary Budget Justification NOTE:

A detailed budget is needed for each year of the

• project. Complete each budget section for the

prime applicant and any/each subcontractor.

Budget and Period Limitations

Funds & Budget Total costs: $4 million over the life of the project Includes direct and indirect costs Indirect costs: up to 40% Institutional base salary up to $200,000 Indirect costs are capped on subcontracts / sub awards The limit for Scientific Travel is $10,000 over the duration of the project. There is no cap on Programmatic Travel Period of Performance 3 years

Detailed Budget

• Personnel
• Consultant
• Equipment
• Supplies
• Travel
• Other Expenses
• Consortium/Contractual Direct Costs
• Consortium/Contractual Indirect Costs
• Prime Indirect Costs

Budget Justification

Provide a narrative that fully supports and explains the basis for the information found in the Detailed Budget Provide sufficient detail to understand the basis for costs, the reason that the costs are necessary, and an explanation for major cost variances – Provide justification as to why the costs are reasonable for the work to be performed Provide a 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, and fringe benefit policy

Letters of Support

All letters of support should be addressed to the PI and institution to demonstrate the commitment of key personnel and supporting

• rganizations 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

• f collaboration of all forms.

Letters of support should be organized in the following manner:

• Letters of organizational support
• Letters of collaboration
• Letters confirming access to patient populations, data sets, and additional

resources

Common Application Errors

Using the wrong browser, access PCORI Online via Chrome or Safari browsers Not entering information into all required fields in the system Not clicking the ‘Save’ button 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

Tips for Success

Adhere to the PFA and Application Guidelines Talk to a Program Officer if you have questions Start and submit early Download PCORI’s Online User Manual for Submitting an Online Application Ensure that all team members can see the application in the system Inform your AO of your intent to submit Submit the completed application before the due date or

• n it by 5:00 PM ET

Resources

Additional Application Resources

Refer to the funding opportunities page in our Funding Center (http://www.pcori.org/funding/opportunities) for the following resources:

PFA and Application Guidelines PCORI Online User Manuals 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

Submission and Key Dates

What When

LOI-Applicant Town Hall November 16, 2015 LOI deadline January 6, 2016 by 5:00pm ET Applicants notified as to whether they have been selected to submit a full application January 7, 2016 by 5:00pm ET Applicant Town Hall (if invited) February 1, 2016 Application Deadline (by invitation only) March 17, 2016 by 5:00pm ET Merit Review Dates May 2016 Awards Announced June 2016 Earliest Start Date June July 2016

Questions and Answers

Submit questions via the chat function in Meeting Bridge Ask a question via phone (press *7)

Contact Us:

• Schedule a call at http://www.pcori.org/content/research-inquiry
• Call 202-627-1884 ( programmatic inquires)
• E-mail us at sciencequestions@pcori.org
• Call 202-627-1885 ( administrative and technical inquires)
• E-mail us at pfa@pcori.org

Thank You