1. Julie Calahan, CCRP Clinical Trials Budget Analyst Health System Contracts Office 1 CRC Basic 2.0 Budgeting for Industry-Sponsored Clinical Trials

2. Clinical Trials Contracts Office Annie Wong – Health System Contracts Director Signatory and Director of Clinical Trials unit Annie Wong – Health System Contracts Director Signatory and Director of Clinical Trials unit Erick Jenkins – Clinical Trials Officer Supervises Clinical Trials unit, negotiates new and complex clinical trial agreements and assists in negotiation of UCOP master agreements, liaison with UC Office of the President and CTSC Erick Jenkins – Clinical Trials Officer Supervises Clinical Trials unit, negotiates new and complex clinical trial agreements and assists in negotiation of UCOP master agreements, liaison with UC Office of the President and CTSC Andrew Jones – Clinical Trials Analyst Negotiates agreements under master clinical trial agreements and some new agreements Andrew Jones – Clinical Trials Analyst Negotiates agreements under master clinical trial agreements and some new agreements Lorie Dilts – Clinical Trials Analyst Negotiates amendments and confidentiality agreements, office and database management Lorie Dilts – Clinical Trials Analyst Negotiates amendments and confidentiality agreements, office and database management Julie Calahan – Clinical Trials Budget Analyst Assists departments with budget development and negotiation, develop clinical trial budgeting policy Julie Calahan – Clinical Trials Budget Analyst Assists departments with budget development and negotiation, develop clinical trial budgeting policy

3. Objectives  Roles of coverage analysis and internal budget  Components of a clinical trial budget  Budget template and examples  Budget negotiation tips and tactics  Resources and questions 3

4. What is a clinical trial? (for the purposes of application of 26% indirect rate*) The controlled, clinical testing in human subjects of investigational new drugs, devices, treatments, or diagnostics, to assess their safety, efficacy, benefits, costs, adverse reactions and/or outcomes. * This rate applies to the Total Direct Cost, and no budgeted item is excluded from the application of indirect. This rate applies regardless of whether a Clinical Trial is based on sponsor -initiated, or an investigator-initiated protocol. 4

5. 5 Industry Sponsored Clinical Trial Approval Process Receive Sponsor Packet (Protocol, CTA & Budget) Send Sponsor Packet to Clinical Trial Budget Analyst and Research Abstractor PI Interest Research Team Drafts Internal Budget (UBT) 1)Gather information from -Research Team Members (CRC, PI) -Quantim -Investigational Drug Services -Other Depts (CCRC, Radiology, Pathology) 2) Use Research Query Tool for current research prices 3) Complete Coverage Analysis Negotiate Budget & Payment Terms w/Sponsor (External Budget) Assistance provided by Research Abstractor and Budget Analyst Send packet to Chair for Approval & Signature Tabled Clinical Trial Contract Packet Forwarded to Dean’s Office for Signature CT Contracts Office - Negotiates Contract Language - Signs Off on Final Budget Research Team determine feasibility: -Scientific Merit -Financial Soundness -Pt Accrual No Yes

6. The role of Coverage Analysis (CA) and internal budget (UBT) 6

7. Coverage Analysis Works To Create Accurate Budget 7

8. How can I use Coverage Analysis? Use to create an accurate budget Provides a list of study events in a Billing Grid Early analysis will: Identify all procedures Identify CPT codes for research costs Identify policies limiting insurance coverage CTSC Coder provides assistance Obtain research costs by CPT code Cost Query Tool Accurate costs=accurate budget Accurate budgeting useful for feasibility, negotiations with sponsors, patient billing, invoicing 8

9. 9 Use the BG to prepare internal budget Look up clinical trial costs by CPT code in Cost Query Tool Base External budget on internal budget Negotiate with sponsors Billing, CTA, Consent Form match

10. Medicare National Clinical Trial Policy 10 Coverage Analysis is a UC requirement for all studies with patient care services billed through UCDMC At UC Davis we can determine when a clinical trial meets national policy guidelines by performing a Coverage Analysis NCD explicitly defines coverage of clinical trial services

11. What does sponsor pay for? What does 3 rd party (Ins co) pay for? 11 Sponsor Insurance/Medicare/Pt Acct needed to clinically manage pt care Insurance/Medicare/Pt Acct services pt receives if not in CT but part of protocol – SOC

12. Billing Grid continued… 12 Tool to create an accurate budget Identify the study events Lists study events in the form of a CPT code Research Costs can be found by CPT code Lists who will be billed (sponsor or insurance billing) Tool to reconcile billing statements

13. Components of a clinical trial budget 13

14. 14 Protocol-related tasks Budget-related tasks IRB Docs Training Pharmacy communication Communications w/Sponsor Start UpClose OutInvoicablesPer Patient Advertisement Office supplies Pharmacy start-up, inventory Translation of Informed Consent Categories of tasks FEES Complete Feasibility Questionnaire from Sponsor Review protocol & study flow Review by Scientific Review Committee (Cancer Ctr) Preparation and return of Sponsor/Site documents Pre-Study Site Selection visit, prepare for & attend Prepare, distribute, collect and copy financial disclosures Obtain and copy CV's Preparatory Research CMS determination Tasks Start-up Costs

15. Close Out Costs 15 Closeout Report Complete Queries Box up Study Records Transport Study Records for storage Closeout Visit, Prepare for & Attend Regulatory close with IRB Close out study account w/Extramural (incl.payroll transfer) Close out invoicing Producing addtl information after study close out Start UpClose OutInvoicablesPer Patient Tasks

16. Invoicable Costs 16 Adverse events x 8 Monitoring Visits x2 Screen Failure x4 Annual Report x1 IRB Docs x1 Admin/Correspondence x1 Start UpClose OutInvoicablesPer Patient Categories of Tasks Mods to Reg Documents Regulatory Binder, Maintain IRB, Communicate Modifications, incl 1572 Contracts, Communicate Modifications Invoicables may or may not happen Each category multiplied by the number of occurrences Must include to come up with the total budget

17. Per Patient Costs 17 Start UpClose OutInvoicablesPer Patient

18. Unified Budget Template (UBT) 18

19. Internal Budget (UBT) Summary Shows anticipated revenue residuals/loss assuming full enrollment of patients completing entire study 19

20. Factors impacting budgets Composition of research personnel The type, phase, and complexity of the protocols involved Screen failure rates The actual time it takes to perform the work Given the organization of clinical trial research services within the research unit Anticipated complications Sample processing and/or shipping logistics Patient treatment logistics and scheduling challenges Data management in busy studies Time limits on patient accrual reporting and data query resolution 20

21. Start-up Costs If you don’t ask for it, you won’t get it Start-up fees should always be non- refundable 21

22. Close-Out and Other Invoicables 22

23. 23 Per Patient Costs – Study Procedures/Labs

24. Per Patient Costs - Other 24

25. 25 Per Patient Costs - Study Activities

26. Per Patient Costs Salary Calculator - linked to all costs throughout the budget 26

27. Completed UBT 27

28. Budget Negotiations 28

29. Budget negotiations…… Sponsor’s initial budget is STARTING POINT for negotiations (perform a thorough analysis of the specific protocol) Keep in mind ……all sponsors and CROs have a business plan to make money Communicate resources available to conduct trial Expertise Facilities Access to large patient population Remain neutral…establish that you represent the University and are negotiating the budget on behalf of the study team A break-even point and bottom line should be determined 29

30. Budget negotiations (con’t)….. Keep the PI in your corner Keep him/her informed Ready to intervene Ready to remind sponsor of the benefits of having UCD as a site Keep momentum going if negotiations are moving quickly Don’t let aggressive CROs push you around Remain calm and exercise some patience Reach out to resources within the UCD research community for advice 30

31. Budget negotiations (con’t)….. Payment Terms REVIEW, REVIEW, REVIEW!!! Advance vs. start-up Interim Payments Payment Withholding Final Payment Screen Failures 31

32. Resources 32

33. Resources 33 Clinical Trials Website UCD Clinical Research Guidebook Process Maps

34. 34 Research Costs - UCDHS Query Tool B6 FIN to provide cost data for clinical trial billing codes

35. 35

36. CPT Codes - Quantim 36

37. 37 Questions ??