1. David Cloutier Director, Research Center Management and Development Budgeting for Industry Sponsored Clinical Trials

2. Objectives Describe costs associated with clinical trial conduct Review a sample internal budget Identify hidden costs Identify the elements of sponsor budget Describe post award activities related to payment and budget changes

3. Budget Prioritization Prioritize budget analysis and feasibility Request a draft budget and protocol as soon as you are approached for the trial The budget and contract can take as long to negotiate as the Informed Consent Document You can make a draft budget while waiting on the sponsor’s budget

4. Interest and feasibility Study the protocol carefully Is the project feasible for your site Academic / Scientific interest Resources Research staff Patient population Identify Your Costs Review the Protocol Schematic and Informed Consent Document

5. Review the Protocol Schematic Hospital procedures (technical fees) Physician practice costs (professional fees) Lab costs How many visits / Length of study Visits until randomization Coordinator time per visit / post visit Compare to visits and procedures listed in the informed consent document

7. Build the Budget Per Patient Costs Study Level Costs

8. Per Patient Costs Breakdown procedures by Coordinator, Physician, and Hospital Fees –ECG cost / Pro Fees / Coordinator filing –Lab tests / review / CRF filing –ECHO cost / Pro Fees / CRF filing –Medical History / CRF filing –Dispensing fees Assign costs for coordinator / staff time Apply Indirect Cost rate – 25% Industry Sponsored Trials

9. Coordinator Fees Regulatory document collection / filing Correspondence filing Case Report Form completion, submission Scheduling for pt visits, tests/scans Participant stipend processing Data query resolution Sponsor invoicing / accounts receivable

10. Study Level Costs Administrative Startup Fee Pharmacy Set Up Fee Document archiving, offsite storage Advertising Unscheduled visits SAE reporting Monitor visits IRB Fees –Initial Review, Amendments, Renewals

11. Protocol Review Site Initiation Visit Contract and Budget Review Investigator Meeting Regulatory Documentation filing Initial IRB Application preparation / submission Informed Consent Document –IRB Requested Revisions –Negotiating ICD w/ Sponsor Office Supplies Startup Fee ($1500 - $5000)

12. Hidden Costs Extended start-up activities / timeline Pre-screening activities Increased hospital procedure costs Unscheduled visits Tracking study accounts receivable Query resolution Amendments

13. The Sponsor Budget Per Patient Amount comparable? Study Level costs covered? Indirect cost rate correct? Enrollment goals feasible? Screen failure reimbursement acceptable?

14. Negotiating Internal budget will differ from sponsor offer Discourage sharing detailed internal budget with sponsor Your internal costs may limit negotiation of future projects Sponsors retain database of previously negotiated budgets Negotiate reimbursement at the same level of detail as sponsor template –Per-visit reimbursements are acceptable –Line item expenses are acceptable

15. Sponsor Payment Terms What is the payment schedule? –Ad Hoc –Quarterly –After Monitor Visits and CRF auditing Are they relying on you to Invoice? –For all payments –Study Level Costs –Per Visit

16. Track your payments Budget statement Payment memo Invoice for your “Study Level Costs” and reimbursable expenses Sponsors miss payments Request periodic payment reports from sponsors to ensure that EFTs were received and directed to the correct fund-org Some sponsors rely on you to invoice for all the visits.

17. Initial Payment Initial payment may include pre-payment  Untangle start-up fees from initial payment by negotiating a “non-refundable” start-up fee

18. Re-Negotiation is an Option Review protocol amendments for new work… –If the amendment changes work load or adds procedures: re-negotiate –If sponsor allows more patients to be enrolled, request more screen failures