Clinical Trials – Industry Sponsored Budgets ICTS Luncheon Clinical Trials – Industry Sponsored Budgets Ashley Tydon Stern Center Business Manager Chao Family Comprehensive Cancer Center

Gather information from the sponsor Step by Step Gather information from the sponsor Protocol, IB All manuals (Lab, Pharmacy, Imaging, Coordinator) Central vendor questionnaires Budget/Contract FDA IND Acknowledgement

High-Level Protocol Review Step by Step High-Level Protocol Review Use an Oncore Task List as a guide Are there any interactions with a patient that will generate a charge in the hospital billing system? Who is providing the drug/device? What ancillary services will I need to use? How many patients do we plan to enroll? How long do we expect the study to be open to accrual and overall?

Collect Research Rates/Quotes Step by Step Collect Research Rates/Quotes Request a calendar/MCA if necessary (this will generate all the hospital based research rates) Requests reviews and quotes from all the applicable ancillary services (IDS, Radiology, Pathology, ICTS) Sort out operational/logistical questions with your PI and CRC to determine the plan for who does what when

Time Estimated for Each Activity (hours) Build your internal budget Internal Budget identifies study costs based on labor costs and research rates for procedures. Billing Grid   Add columns and rows to accommodate the # of visits, procedures and activities as defined in the protocol Cycle Screening Cycle 1 Cycle 2 Cycle 3 FUP # of Per Patient Study Procedure/Labs CPT Code Day -28 1 30 days post 3 mo occurences Study Activities Time Estimated for Each Activity (hours) Total Hrs/Activity Total Cost ICF 0.00 $0.00 History/PE/PS Con Meds Adverse Events ECG (supplied centrally) Pregnancy Test CBC w/ Diff Coags Archived Tissue Specimen QoL Drug Compliance Total CRC Hours CRC Per patient 0.00% PI Oversight PI Per patient Data Manager DataPer patient Administrative Admin Per pt Total Salary

Negotiate your sponsor’s external budget External budgets are negotiated with Industry Sponsors based on the Fair Market Value The external budget must cover all the costs included in the internal budget. Leave yourself room to negotiate Formats for sponsor budgets vary, as each sponsor requires their own format The bottom line here is most important – don’t be afraid to get creative.

Helpful Hints Don’t forget about the payment terms! Standardize your start-up and administrative fees to avoid haggling on big ticket admin items Know your audience and be service-orientated A word about fee for service (fixed price contract) agreements Don’t take their first offer – sponsors expect you to negotiate The power of the PI

Questions?