PCORnet Obesity Observational Research Initiative Applicant Town Hall March 23, 2015 1
Agenda Submitting Questions: Programmatic Overview Submit questions via the chat function in Meeting Bridge. Administrative Overview Ask a question via phone Questions and Answers (an operator will standby to take your questions). 2
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 Objectives of this PFA: • Support research on important unanswered clinical questions faced by patients and their Number of Awards : Up to 2 clinicians using PCORnet’s Distributed (one per special interest topic) Data Research Network (DRN) • Formally test and evaluate the capacity of Budget: Up to $4.5 million in PCORnet’s data infrastructure and the total costs per award functionalities of the Distributed DRN , and report on the readiness of PCORnet’s Project period: Up to 2 years 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 organize 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 of 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 outstanding 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? Applications are reviewed against four criteria: • Technical merit Applications are reviewed by a panel • Patient-centeredness of scientists, patients, and stakeholders. • Patient and stakeholder PCORI’s Board of Governors makes funding decisions based on merit engagement review and staff recommendations. • Testing and evaluation of PCORI will issue a contract once there is a fully agreed-upon study PCORnet data infrastructure protocol. The study will commence after PCORI and the awardee agree on 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 of 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 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 • Professional Project/Performance Patient/Stakeholder Profile/Biosketch Site(s) and Resources Partner Biosketch 19
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 organization’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.
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