PCORnet Obesity Observational Research Initiative Applicant Town - - PowerPoint PPT Presentation

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Applicant Town Hall March 23, 2015

PCORnet Obesity Observational Research Initiative

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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 Overview Questions and Answers

Programmatic Overview

Maryan Zirkle, MD, MS, MA Program Officer, CER Methods and Infrastructure

PCORnet Obesity Observational Research Applicant Webinar PFA:

pcori.org/funding/opportunities

Obesity Observational Research Initiative

Number of Awards: Up to 2 (one per special interest topic) Budget: Up to $4.5 million in total costs per award Project period: Up to 2 years

Objectives of this PFA:

• Support research on important unanswered

clinical questions faced by patients and their clinicians using PCORnet’s Distributed Data Research Network (DRN)

• Formally test and evaluate the capacity of

PCORnet’s data infrastructure and the functionalities of the Distributed DRN, and report on the readiness of PCORnet’s data infrastructure for observational research.

• Provide an early opportunity for clinical data

research network (CDRN) and patient powered research network (PPRN) investigators, patients, and stakeholders to

• rganize and collaborate in a multisite study

and develop an efficient, collaborative process for doing so.

Topics for consideration

PCORI is interested in the following special interest topics: (1) What is the comparative effectiveness of different bariatric surgical procedures (Roux-en-Y gastric bypass, sleeve gastrectomy, and adjustable gastric banding) with respect to initial weight loss; weight regain; and the occurrence of obesity- related outcomes including the resolution of prevalent type 2 diabetes, or incidence or recurrence of type 2 diabetes? (2) What are the comparative effects of alternative antibiotics used during the first 2 years of life on body mass index and risk

• f being overweight or obese during the 3rd to 5th years of life?

Study Characteristics

• Studies benefits and harms of the intervention as delivered in

typical clinical and community settings

• Compares at least two alternative clinical approaches
• Compares health outcomes that are meaningful to the patient

population under study

• Uses PCORnet data infrastructure for collection of outcomes to

test the ability of PCORnet to advance clinical CER

Additional Guidance

• PCORI will consider up to one additional secondary research aim

per study that engages patients from the PPRN communities through surveys, interviews, focus groups, or other appropriate methods to

• (1) elicit patient preferences around the risks and benefits of the study

treatments, and/or

• (2) collect relevant patient-reported outcomes (PROs) meaningful to patients

living with obesity

• PCORI is requiring the submission of a formal testing and evaluation

component to report on the readiness of PCORnet’s data infrastructure and the use of the DRN - led by the PCORnet Coordinating Center

• PCORnet’s Steering Committee has pre-selected 3 PIs for each

potential study from a list of nominations submitted by PCORnet members (detailed communication has gone out to all PCORnet network PIs)

Selection of PIs

The Executive Committee met on Friday, February 27th to review the nominees for the PI of the two obesity trials. Sixteen PCORnet colleagues were nominated by network partners and the Coordinating Center as potential PIs. EC chose three

• utstanding members to be PIs of each study.

Short- and Long-Term Outcomes related to Bariatric Surgery

• David Arterburn, clinical investigator, PORTAL
• Kathleen McTigue, clinical investigator, PaTH
• Neely Williams, patient partner, Mid-South

Long-Term Effects of Antibiotics on Childhood Growth

• Chris Forrest, clinical investigator, PEDSnet
• Matt Gillman, clinical investigator, Obesity Task Force
• Douglas Lunsford, patient partner, PEDSnet

Application Development

• Applications may be submitted by Phase I CDRNs and PPRNs with

the PCORnet Coordinating Center

• Network partners are encouraged collaborate on the development of

the research plan, inclusive of a study protocol, resulting in the submission of one cohesive proposal per topic

• Seek out other interested colleagues including the selected study PIs in the

development of an application

• If agreement cannot be reached on a single study application and protocol (per

award), PCORI will review multiple proposals

PCORI will make up to two awards under this PFA-one per special interest topic

CDRN & PPRN Participation

• PCORI does not expect that all CDRNs or all PPRNs will participate
• Awardee institution, in collaboration with the study PIs and PCORnet

coordinating center is expected to select participating sites based on:

• Analysis of preliminary data provided by all CDRNs using the common

data model (CDM) to the extent possible,

• Level of interest in the topic,
• Current readiness of the network to participate effectively,
• General considerations of sample size, availability of funds, and study

efficiency.

• Research Plan requires how and why each research site has been

selected to participate in the trial

• CDRNs and PPRNs providing trial sites will subcontract with the prime

awardee

How are applications reviewed

pcori.org/content/merit-review-process

How Are Applications Reviewed?

• Technical merit
• Patient-centeredness
• Patient and stakeholder

engagement

• Testing and evaluation of

PCORnet data infrastructure

Applications are reviewed against four criteria:

• Applications are reviewed by a panel
• f scientists, patients, and

stakeholders.

• PCORI’s Board of Governors makes

funding decisions based on merit review and staff recommendations.

• PCORI will issue a contract once

there is a fully agreed-upon study

• protocol. The study will commence

after PCORI and the awardee agree

• n the final protocol content.

Administrative Overview

Donna Gentry, MA Contracts Administrator, Pre-Award

Applicant Resources

Refer to PCORI’s Funding Center for the following resources:

• PFA and Application Guidelines
• PCORI Online User Manuals
• General Applicant FAQs: http://bit.ly/applicant_faqs
• PCORI Online: https://pcori.fluxx.io/
• Research Methodology: http://www.pcori.org/node/4020

Putting the application together

pcori.org/apply

Research Plan Template

Research Plan Template includes: Research Strategy – 25 Pages Use the Research Strategy to describe:

• A. Background
• B. Study Design or Approach
• C. Engagement Plan
• D. Project Milestones and Timeline
• E. Research T

eam and Environment

Research Plan Template - Continued

• Study Protocol – 75 Pages
• Evaluation of Data Infrastructure – 15 Pages

Dissemination and Implementation Potential – 2 pages

• Replication and Reproducibility
• f Research and Data Sharing – 2 pages
• Protection of Human Subjects – 5 pages
• Consortium Contractual Arrangements – As needed
• References Cited – 10 pages
• Management Approach – 20 pages
• Appendix (Optional) – 10 pages

All sections of the Technical Proposal should be saved as “TechnicalProposal_PI Last Name” and uploaded into PCORI Online as a single file.

People and Places Template

19 Professional Profile/Biosketch Patient/Stakeholder Partner Biosketch

• 5 pages per individual, no limit on number of individuals
• 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

Project/Performance Site(s) and Resources

Budget Template

Total Costs: $4.5 Million This includes ALL direct and indirect costs Budget Template: Include all as part of Budget Template

• Detailed Budget for each year of the project for the prime

applicant and any subcontractor(s) proposed in your application;

• Budget Summary for entire project;
• Budget Justification;
• Also provide the Indirect Cost rate letter – for prime and subs;
• Fringe benefit rate verification

Letters of Support

Demonstrate the commitment of key personnel and/or your

• rganization’s leadership to the research project
• Follow the guidance in the Letters of Support Table
• Address letters to the Principal Investigator
• Not required for research assistants or others who are not

contributing in a substantive, measurable way to the project

• Letters from your leadership and/or organizations

supporting dissemination and implementation of research findings are strongly encouraged

• Consultants, coordinating center sites, and DSMB should

also submit a letter of support.

PCORI Online System

pcori.fluxx.io

Using the PCORI Online System

All application materials must be submitted at pcori.fluxx.io

• Use Google Chrome or Safari browsers
• Enter information into all required fields
• Click the “Save and Review” tab on the left side navigation

pane and then “Save and Review” on the main page

• Use the correct naming conventions for all documents and

select the correct drop-down options when uploading documents

• Designate the correct individuals to your application
• Refer to our PCORI Online user manual for guidance.

Using the PCORI Online System

All application materials must be submitted at pcori.fluxx.io

• Use Google Chrome or Safari browsers
• Complete required fields -
• PI and Contact information
• Project Information
• Technical Abstract – 6,000 characters/spaces
• Project Narratives – 1,000 characters/spaces
• Public Abstract – 6,000 characters/spaces
• Key Personnel – As needed
• Milestones - As needed

Using the PCORI Online System

All application materials must be submitted at pcori.fluxx.io

• Upload –
• Research Plan Template – Page limits as described
• People and Places Template - Page limits as described
• Budget Template - As needed
• Letters of Support – As needed

Reminders

Key Dates

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What When

Have a Question?

Research/Programmatic Questions sciencequestions@pcori.org | (202) 627-1884 Administrative/Financial/Technical Questions pfa@pcori.org | (202) 627-1885

Thank you!