Budgeting for Clinical Trials

1. Budgeting for Clinical Trials Carolyn Strickland, RN, BSN, CCRC Research Billing Services Consultant Office of Contracts Management

2. Objectives • Review basics of a clinical trial budget • Review “PriceChecker” on Starbrite • Provide tips on the most common mistakes we see in OCM

3. Most Common Budget Mistakes With Budgets for Industry-Initiated Projects • Missing IDS fees • Missing IRB fees • Lack of knowledge re use of CRC space & fees • Accounting for full staff effort • VUMC indirect costs • Start-up Fee • Reimbursement for protocol procedures • Annual cost increase for budget items • Archive fees

4. Purpose of a Budget • Understand the cost • Identify who will pay for what • Documentation of cost • Informed decision

5. Getting Started • Carefully review protocol • Input from investigator, coordinator, sponsor • Know institutional requirements- finance, compliance • Price quotes

6. Developing Budget • List study events and staff time • Identify hidden costs • Account for institutional indirect -industry sponsored 29% • Identify standard of care (Routine Care) and research costs

7. Routine Care • Principle investigator and coordinator must carefully identify usual and customary care procedures vs. research specific procedures • Usual and customary care procedures would probably be performed if the patient were not on the study • Routine care tests and results may be used for research

8. Research Costs • Research specific procedures would probably not be performed if the patient were not on a study • Can not bill insurance for any item that is reimbursed by sponsor

9. Schedule of Events example STUDY VISIT FLOW CHART *ET=Early Termination

10. Start-up Costs • Protocol review • Staff training • Budget preparation • Site selection/initiation visit • Investigator meetings • Development of study tools • Administration (budget) • Regulatory

11. Start-up Costs • Nonrefundable • Up front • Average start-up fee $10,000

12. Fixed Costs • IRB fees- Institutional charge for IRB review, amendments, annual review • Archive fees • Pharmacy review; set-up fee, annual fee, close-out fee • External audit fee • Radiology set-up fee • Lab set-up • Close out activities

13. Personnel costs • Screening • Outreach • Conference calls and email • Patient visits • Study documentation • Regulatory • Data management • SAEs • Monitoring visits • Shipping • Meetings

14. Study Subject Costs • Assessments- medical history, physical exam, adverse events • Medical procedures- radiology, cardiology • Professional fees • Office visits/facility fees • Lab work • Medical and/or lab supplies • Hospital bed • VICTR/Clinical Research Center • Screen Failures

15. Administrative Costs • Office supplies • Telephone or fax charges • Pager • Voicemail • Computer • Postage/Shipping

16. Payment terms • Critical • Negotiated by the department • Advance payment • Payment trigger • Payment schedule • One time expenses

17. Payment terms • Prorated payment • Annual cost adjustment • Payment adjustments • Holdback -Per institution policy holdback can not exceed 20%

18. Sponsor Budget

19. Sponsor Budget Exhibit B – Clinical Study Financial Terms $5000 Investigator Fee $3750 IRB Fee $5000 Lab Fee $700 Per patient Fee (estimate 150 patients) estimate $1,050,000 $118,750 Estimated Total (based on 150 patients) $17,812.50 15 % payable upon IRB Approval (Institution will invoice Sponsor) $12,963.75 Per month for six months after first patient enrolled. Total $77,782.50 $23,155.00 At close out based on 150 patients Institution will invoice Sponsor in writing Any patients over 150 forecasted billed at $700 /per patient Any patients under 150 deducted at $700/per patient IRB amendments and continuing reviews will be an invoiceable pass-through cost at $500 each amendment, $750 each continuing review. All payments made pursuant to this Agreement shall be made payable to Vanderbilt University Medical Center and directed to the following address: Attn: Stephen Todd Associate Director Department of Finance Academic and Research Enterprise Vanderbilt University Medical Center Dept AT 40303 Atlanta, GA 31192-0303 Each payment voucher should reflect IMI’s name, Protocol Number, and the Principal Investigator’s name. Institution’s Federal Tax Identification Number is____62-0476822_______.

20. Negotiation • Budget process requires negotiation • Documentation • Confidence • Ideal vs. bottom line • Compromise • Mutual agreement

22. Example of Price Checker Screen – Basic Instructions

23. Most Common Budget Mistakes With Budgets for Industry-Initiated Projects • Missing IDS fees – 4 fees including: Initial submission - ~$2000-$3000; Annual fee - ~$1650 (varies); Close-out - ~$650; Dispensation of drug – varies. Always get an IDS quote. • Missing IRB fees – 3 fees including: Initial submission - $2250; Amendments each $500; Continuing Review - $750. • Lack of knowledge re use of CRC space & fees • Accounting for full staff effort • A misunderstanding or lack of knowledge re VUMC indirect costs (continued next slide)

24. Most Common Budget Mistakes With Budgets for Industry-Initiated Projects (continued) • Failure to obtain Start-up Fee • Inadequate or no reimbursement for protocol procedures; use tools such as Price-Checker; i.e. pathology fees for tissue samples • Failure to build in annual cost increase for budget items • Archive fees

25. Questions?

26. Contact for Budget Assistance Carolyn Strickland, RN, BSN Research Billing Services Consultant Office of Contracts Management 936-6691 carolyn.strickland@vanderbilt.edu