1. Mid-South CDRN Sustainability Models
September, 16, 2016
Medical University of South Carolina
Charleston, SC

2. PCORnet Sustainability Plan

3. PCORnet Sustainability Model
At the end of Phase II, PCORnet will need to find a sustainable way to support
large clinical studies and trials
comparative effectiveness research and
health system research

4. PCORnet Value Proposition
“Better, Faster and Cheaper platform with scale for patient-centered clinical research”
Depth and breadth of clinical domains
Patient focused research agenda
Differentiated common data model that is modifiable and quick
Network of institutions to aid with diffusion
Program office coordinates and facilitates study execution
May be conflicting, due to organizations having their own trial coordinating centers
Cost-efficient infrastructure
Rapid diffusion and distribution of knowledge

5. Network Revenue Sources

6. PCORnet moving forward to 501c3 Status
Develop governance model
Develop operational and business plan
Need to establish legal entity
Articles of Incorporation-Spring 2017
Each CDRN or Node will decide to join governance
Hire business development function within entity
Need guidance on how to talk with COI officers at our organizations
Kick start CRGs
Proposal development support for CRGs
PCORI to provide additional funding for infrastructure?

7. PCORnet Membership - Network Subscription
Who?
Government , Non-Profit and Industry
How?
Balancing industry requests and patient-centered mission
Align industry needs with patient/advocacy group needs
Educate Investigators about what PCORnet offers
Patient population, recruitment, coordination, CDM etc.
Differentiate PCORnet from current work
Why?
Industry studies important for revenue

8. Network access and subscription Revenue

9. PCORnet Estimated Costs per CDRN/Data Node
PCORnet estimates CDRN maintenance between $ k/year
This includes the “keep the lights on” cost
Does not include costs to run counts, participate in studies, or hardware
Our CDRN Specific Costs Need to include:
stakeholder engagement,
administrative costs for proposals,
prep work, etc.
Governance Structures
Not all data nodes equal
Different cost for different nodes

10. Program Office Cost Model
DRAFT
DRAFT

11. DRAFT Network Cost Model
Keep the lights on cost estimates which includes:
Coordinate 2-3 data refreshes each year
Maintain and demonstrate data quality standards across nodes
Query fulfillment to support for
Study feasibility assessment
Business development
Data quality standards
DRAFT

12. Data Node Level Cost Model
Keep the lights on cost estimates includes:
Cadence for data refreshes
Quarterly – high-quality DMs
2-3 for other DMs
Monthly refreshes in 5-7 years?
Maintain and demonstrate data quality standards
Query fulfillment to support for
Study feasibility assessment
Business development
Node allocation: $100K-$150K/ year
PI – 5%
Co-I 5%
Ops Director – 5%
PM – 15%
Analyst – 20%
DRAFT

13. Collaborative Research Groups
PCORNet Collaborative Research Groups
Develop strategic research agenda
Support resources to convert disease into study and grant proposals
7 CRGs expanding to 10 by year 7
$125K to support each CRG each year
DRAFT

14. PCORnet Sustainability Summary

15. Discussion
Are the proposed “operational” costs covered by the proposed supplemented amount ($ K/year)?
If not, what is missing?
Are there other revenue schemes not already listed?
Are there any institutional barriers to the proposed PCORNet Business model?
Industry collaborations?
Indirect Rate?
What are steps we as a CDRN can do to cover missing costs?

16. Mid-South CDRN Sustainability

17. Considerations for sustainability model
Underlying Operations and Infrastructure Costs
Lead site cost
Operational Cost across CDRN nodes
Research study portfolio distribution
Number
Size
Sponsor (Government, industry, non-profit)
Stakeholder Engagement – Advisory Council and Stakeholder Membership on Governance Boards
Contribution margin and indirect costs
Institutional Support

18. Mid-South CDRN Intake Resources Overview
Intake Management and Operations
CDRN Level Navigator
Review Intake Form and Front Door Opportunities
Meet with investigator
Prepare materials for leadership review
Disseminate approved study opportunities to sites
Track site participate and send CDRN level materials to investigators
Complete paperwork (front door only)
Site Coordinator/Navigator
Assess feasibility of study at site
Provide engage site investigators for CDRN Opportunities
Gather and send requested study specific materials to CDRN Navigator

19. Mid-South CDRN Operations Overview
Network Management and Operations
PIs
Co-Is
Project Manager
Coordinator

20. Mid-South CDRN Governing Bodies
CDRN Governance Boards:
Weekly Leadership Meeting:
Review CDRN resource request, discuss deliverables and CDRN operations
Membership includes: PIs and Co-Is at each site, PM for CDRN and Carolinas Collaborative and navigator
Operations Committee
Review CDRN Operations and Goals
Membership includes: PIs and Co-Is, PM for CDRN and patient representative
HRS (Research Committee)
Review research opportunities and external data linkage
Membership includes: PIs and Co-Is
4. Oversight Council
Oversees CDRN activity and direction
Membership includes institutional leaders at each site.
Governing Boards
Leadership
PIs/CO-Is
Coordinator
Navigator
Operations
Members
Stakeholders
Oversight
HRS
PIs/Co-Is

21. Mid-South CDRN Data Resources Overview
Data Network Management and Operations
Programmer - ETL
Programmer - Data Acquisition
IT Project Manager
Hardware
External data linkage management and operations
IT Project Manager to oversee reporting and governance of these resources

22. Project Specific Considerations
Project Specific Programmer
Project Specific Project Manager
Project Specific phenotyping
Costs will vary based on research study portfolio distribution:
Number
Size
Sponsor (Government, industry, non-profit)
Mid-South CDRN Data Costs: Programming time to run queries and pull data
Site
Internal Investigator
Commercial
Non-Profit
Vanderbilt
$120/hr
$192/hr
$144/hr
VHAN
Greenway*
$175/hr
UNC
$75/hr
N/A
Duke
HSSC -
* Greenway will charge a minimum of $1,000 for programming time

23. Stakeholder Advisory Committee Review
The Stakeholder Advisory Board supports and facilitates patient engagement efforts including our stakeholder review of CDRN studies. The board consists of:
4 patients
4 clinician
Support for the Committee requires:
Meeting Supplies
GoTo expenses
Food
Facilitator
Coordinator

24. Discussion
How do we financially support the governing body? Do we maintain all activities beyond Year 2 and Year 3?
Do PCORNet Core rates need to be developed across the CDRN?
Do we or do we not attempt to create cost consistency across sites?
How do we account for unsupported operation work ( oversight and data needs)
Get incorporated in the fee-for-service rate?
Charge a Service Fee for use of the CDRN? May not be allowable by some funding sources