The National Patient-Centered Clinical Research Network:
Patient-Powered Research Networks (PPRN)
Building a National Data...
Agenda
Introductions
About PCORI: Mission and Vision
Overview of National Patient-Centered
Clinical Research Network
Ideal...
Introductions
Joe Selby, MD, MPH
Executive Director
Bryan Luce, PhD, MBA
Chief Science Officer
Rachael Fleurence, PhD
Acti...
About PCORI
4
PCORI’s Mission and Vision
 The Patient-Centered Outcomes Research Institute (PCORI) is an independent, non-profit health...
PCORI’s National Priorities
PCORI’s funding cycles focus on its National Priorities, which were put forth in PCORI’s autho...
National Patient-Centered Clinical Research Network
7
National Patient-Centered Clinical Research
Network
The goal of PCORI’s National Patient-Centered Clinical Research Networ...
National Patient-Centered Clinical Research
Network
The core components of this network will be:
 Clinical Data Research ...
10
National Patient-Centered Clinical
Research Network: Our Vision
Steering Committee
- Awardees
- PCORI
- AHRQ, NIH,
FDA,...
Ideal PCORI PPRN Characteristics,
Activities to Focus On
11
12
Ideal PPRN Characteristics: Patients
 Is comprised of patients linked by a common condition,
may also include interest...
13
Ideal PPRN Characteristics: Systems
 Is willing to participate in a program-wide Steering
Committee to help resolve ne...
14
Ideal PPRN Characteristics: Administrative
 Has a governance structure and operating policies
that ensure patient cont...
15
PPRNs Should Concentrate on the Following
Activities During the 18 months Initiative
 Patient recruitment to their net...
16
Patient-Powered Research Networks
$12million is available to support up to 18 new or existing PPRNs for 18 months.
Types of organizations that may apply
17
Studies PCORI Is Not Soliciting Under This
PFA
18
Under this PFA, PCORI is not intent on providing maintenance funds to
su...
Letter of Intent (LOI) Submission
19
Understanding the Letter of Intent (LOI)
 A LOI is required in order to submit an application.
 LOIs will be reviewed an...
21
The PPRN LOI should address the
following:
 Project/network plan: Describe the network’s origin, mission, and
current ...
22
The PPRN LOI should address the
following: (additional information)
 LOI supporting documentation: :
 References Cite...
LOI Review Criteria
23
PPRN LOI Review Criteria
24
 The LOI will be evaluated internally by PCORI based
on the project/network plan and on patie...
Administrative Matters
25
Funds, Budget and Period Limitations
26
Note: This is one-time announcement. It will not be reissued.
Funds & Budget
 Fun...
Eligibility Requirements
Applications may be submitted by:
 Any private sector research organization, including any:
• no...
Key Dates: Wednesday, June 19 2013
Key Dates: PCORI Funding Announcement
Action Dates
System Opening Date May 15
Letter of...
Resources
29
Resources
View training materials through
the Quick Links for Applicants bar.
Access:
 Application training
 Opportuniti...
31
This is just the beginning…
Questions
Submitting Questions:Please use this time to ask any question
you may have about the PFA or the LOI
submission p...
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The National Patient-Centered Clinical Research Network: Patient-Powered Research Networks (PPRN)

  1. 1. The National Patient-Centered Clinical Research Network: Patient-Powered Research Networks (PPRN) Building a National Data Infrastructure to Advance Patient- Centered Comparative Effectiveness Research (CER) Town Hall for Applicants: June 2013 1
  2. 2. Agenda Introductions About PCORI: Mission and Vision Overview of National Patient-Centered Clinical Research Network Ideal PPRN Characteristics Letter of Intent (LOI) Requirements LOI Review Criteria Administrative Matters Resources Live Q&A Submitting Questions: Submit questions via the chat function in Meeting Bridge Ask a question via phone (an operator will standby to take your questions) 2
  3. 3. Introductions Joe Selby, MD, MPH Executive Director Bryan Luce, PhD, MBA Chief Science Officer Rachael Fleurence, PhD Acting Program Director James Hulbert Contracts Administrator Martin Duenas, MPA Contracts Director Martin Brown, PhD Sr. Scientific Advisor
  4. 4. About PCORI 4
  5. 5. PCORI’s Mission and Vision  The Patient-Centered Outcomes Research Institute (PCORI) is an independent, non-profit health research organization authorized by the Patient Protection and Affordable Care Act of 2010.  PCORI funds patient-centered research to assist patients, caregivers, and other stakeholders in making informed health decisions. Mission PCORI helps people make informed healthcare decisions and improves healthcare delivery and outcomes by producing and promoting high integrity, evidence-based information that comes from research guided by patients, caregivers, and the broader healthcare community. Vision Patients and the public have the information they need to make decisions that reflect their desired health outcomes. 5
  6. 6. PCORI’s National Priorities PCORI’s funding cycles focus on its National Priorities, which were put forth in PCORI’s authorizing legislation. These five broad areas comprise PCORI’s National Priorities for Research and encompass the patient- centered comparative clinical effectiveness research PCORI will support. Assessment of Prevention, Diagnosis, and Treatment Options Improving Healthcare Systems Communication and Dissemination Addressing Disparities Accelerating Patient- Centered Outcomes Research and Methodological Research
  7. 7. National Patient-Centered Clinical Research Network 7
  8. 8. National Patient-Centered Clinical Research Network The goal of PCORI’s National Patient-Centered Clinical Research Network Program is to improve the nation’s capacity to conduct CER efficiently, by creating a large, highly representative, national patient-centered clinical research network for conducting clinical outcomes research. The vision is to support a learning US healthcare system, which would allow for large-scale research to be conducted with enhanced accuracy and efficiency.
  9. 9. National Patient-Centered Clinical Research Network The core components of this network will be:  Clinical Data Research Networks (CDRNs), which are system-based networks (such as hospital systems) that have the potential to become an ideal electronic network, without structural impediments.  Patient-Powered Research Networks (PPRNs), which are groups of patients interested in forming a research network and in participating in research.  A Coordinating Center which will provide technical and logistical assistance under the direction of the Steering Committee and PCORI Staff. Specifically, this program will promote:  A more comprehensive, complete, longitudinal data infrastructure.  Broader participation of patients, clinicians, health systems, and payers in the research process.  Improvements in analytic methods for both observational and experimental CER.
  10. 10. 10 National Patient-Centered Clinical Research Network: Our Vision Steering Committee - Awardees - PCORI - AHRQ, NIH, FDA, ONC, CMS Scientific Advisory Board Special Expert Group Coordinating Center Staff
  11. 11. Ideal PCORI PPRN Characteristics, Activities to Focus On 11
  12. 12. 12 Ideal PPRN Characteristics: Patients  Is comprised of patients linked by a common condition, may also include interested caregivers or clinicians, and is enthusiastic about participating in research.  Is interested in and willing to increase the amount of information collected (suitable for research) from an activated patient community of at least 50,000 patients (less for patients with rare disorders).  Is willing to explore new approaches for patient members to contribute their electronic clinical data to the PPRN (e.g. use of Blue Button technology).  Is willing to explore new approaches for patient members to collect self-reported data.
  13. 13. 13 Ideal PPRN Characteristics: Systems  Is willing to participate in a program-wide Steering Committee to help resolve network- wide challenges  Is willing to collaborate with other awardees, with the aim of:  converging on a standards-based, inter- operable approach to building patient-powered networks  merging in a subsequent funding cycle, with clinical research data networks
  14. 14. 14 Ideal PPRN Characteristics: Administrative  Has a governance structure and operating policies that ensure patient control, and can establish relationships with qualified researchers.  Can accumulate relevant clinical and patient- reported outcomes data from a high proportion (at least 80%) of the membership.  Is interested in being actively involved in planning and conducting dissemination of research findings to patients and providers.  Has strategies to enhance and report the diversity and the representativeness of the patient community as it expands.
  15. 15. 15 PPRNs Should Concentrate on the Following Activities During the 18 months Initiative  Patient recruitment to their network.  Establishment of standards-based data infrastructure and policies to support these efforts.  Characterization of the network membership in terms of demographic and clinical characteristics.  Refining the process for identifying research needs of greatest interest to patients.  Collection of clinical data from providers leveraging the View, Download, Transmit (VDT) requirements of Meaningful Use and other Blue Button efforts.  Collection of patient generated information, including patient reported outcomes information.
  16. 16. 16 Patient-Powered Research Networks $12million is available to support up to 18 new or existing PPRNs for 18 months.
  17. 17. Types of organizations that may apply 17
  18. 18. Studies PCORI Is Not Soliciting Under This PFA 18 Under this PFA, PCORI is not intent on providing maintenance funds to support existing work of current networks. Rather, we are looking to transformational work that will move us toward the goal of the national network. Reminder: Please refer to the PFA for a detailed description of what PCORI is seeking through this PFA.
  19. 19. Letter of Intent (LOI) Submission 19
  20. 20. Understanding the Letter of Intent (LOI)  A LOI is required in order to submit an application.  LOIs will be reviewed and approved.  Applicants will receive an invitation to submit an application after submitting a LOI.  An Investigator can only be listed as a PI on one LOI.  A organization may be a participant in no more than two applications. Of note: PCORI encourages applicants to submit their LOI and application before the stated due date. LOIs and applications are due 5:00 pm EST. 20
  21. 21. 21 The PPRN LOI should address the following:  Project/network plan: Describe the network’s origin, mission, and current size and:  Capacity of the network to grow during the 18-month period.  All current partnerships and/or plans to partner with other organizations during the 18-month funding period.  Capacity and willingness to link and collaborate with other networks.  Readiness to adequately perform on each of the ideal features of the PPRN  Personnel: Briefly state the qualifications of the PI and key personnel to perform the described project.  Patient engagement: a brief description of the items of concern and relevance to patients (governance, privacy etc.) and of the capacity of the network to support patient-centered outcomes research.  Impact and relevance to patients and PCOR: a brief description of how the network will contribute to PCORI’s overall goal of establishment of a unified national patient-centered clinical research network for future PCOR studies.
  22. 22. 22 The PPRN LOI should address the following: (additional information)  LOI supporting documentation: :  References Cited (one-page limit).  List of Abbreviations, Acronyms, and Symbols (two-page limit).  Biographical Sketch of the Principal Investigator(s) (four- page limit per individual). Notes:  The LOI 4-page limit applies to text and any figures, tables, graphs, photographs, diagrams, pictures, pictorials, and cartoons.  URLs included providing additional information to expand the LOI will not be reviewed.  This limit excludes the LOI supporting documentation.
  23. 23. LOI Review Criteria 23
  24. 24. PPRN LOI Review Criteria 24  The LOI will be evaluated internally by PCORI based on the project/network plan and on patient engagement and personnel.  LOIs will be reviewed based on fit of the applicant network with the goals of the Cooperative Agreement and feasibility to complete work within the budget and project period proposed.
  25. 25. Administrative Matters 25
  26. 26. Funds, Budget and Period Limitations 26 Note: This is one-time announcement. It will not be reissued. Funds & Budget  Funds available: up to $12 Million  Cooperative Agreement: up to 18  Maximum $1,000,000 total costs per year  Indirect costs: up to 40%  Request for exceptions can be made during the LOI submission Period of Performance  Maximum of 18 months  There are no exceptions. You can not request a longer period to complete this project
  27. 27. Eligibility Requirements Applications may be submitted by:  Any private sector research organization, including any: • non-profit organization • for-profit organization  Any public sector research organization, including any: • university or college • hospital or healthcare system • Laboratory or manufacture • unit of state or local government  Only US-based organizations may apply as primary institutions  Nondomestic Components of Organizations based in the United States Please Note: Individuals are not eligible to submit applications to PCORI. 27
  28. 28. Key Dates: Wednesday, June 19 2013 Key Dates: PCORI Funding Announcement Action Dates System Opening Date May 15 Letter of Intent (LOI) Due Date Wednesday, June19 Informational Training Programs CDRN: Tuesday, June 4th 3:00 PM PPRN: Thursday, June 6th 3:00 PM Notification of LOI status Wednesday, July 17 Application Deadline Friday, September 27 Merit Review Dates October - November Awards Announced December 2013 Earliest Start Date January 28
  29. 29. Resources 29
  30. 30. Resources View training materials through the Quick Links for Applicants bar. Access:  Application training  Opportunities for webinars  Reviewer training  Visit the Funding Center for:  PFAs  Templates  Instructions  Key dates  FAQ’s 30
  31. 31. 31 This is just the beginning…
  32. 32. Questions Submitting Questions:Please use this time to ask any question you may have about the PFA or the LOI submission process. If we are unable to address your question during this time, e-mail the help desk at pfa@pcori.org. 32 Submit questions via the chat function in Meeting Bridge Ask a question via phone (an operator will standby to take your questions)
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