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

PCORnet Sustainability Plan

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

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

Network Revenue Sources

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?

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

Network access and subscription Revenue

PCORnet Estimated Costs per CDRN/Data Node PCORnet estimates CDRN maintenance between $100-170k/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

Program Office Cost Model DRAFT DRAFT

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

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

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

PCORnet Sustainability Summary

Discussion Are the proposed “operational” costs covered by the proposed supplemented amount ($100-170K/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?

Mid-South CDRN Sustainability

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

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

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

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

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

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

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

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