New Trial Start-Up: Budgeting

A Word About the Importance of Budgeting for Industry Sponsored Trials

Without an properly negotiatied and prepared budget, you and the institution will lose money on a clinical trial. Because a clinical trial contract is a fixed-price agreement, you are obligated to perform the work described in the contract, even if your actual costs exceed the total contracted amount.

The sponsor may inititally quote a budget amount allocated to each site, or may ask you to develop a budget for their review. In the case of a sponsor-determined budget, the quoted amount may be adequate or generous, but this is often not the case.

In most cases, a reasonable compromise can be reached after performing a cost analysis and reporting those calculated costs to the sponsor. However, on occasion it may be necessary for you to turn down a clinical trial because of an inadequate budget offer.

A Word About the Importance of Budgeting for Federally Funded Trials

In addition to contacting OSR for guidance with your grant appliction, it's also critical that you contact the CTO at this time for help in developing an accurate study budget. Federal guidelines are very specific about fees and costs that may be included on study budgets and require that you be provided with up to date information about the price of hospital services.

Current Costs Associated With Clinical Trials

• IRB fee is $2000 per study
• CTO fee is $1100 per study
• The Research Pharmacy has a $1000-$3000 start-up fee and:
  • A drug dispensation fee assessed per the Research Pharmacy Fee Schedule (contact the CTO for a copy of this schedule)
  • A $500 - $2000 Annual Renewal Fee for protocols extending beyond one year
• Clinical Procedures and Services:
  • Please contact the CTO (Pamela Rampersaud at 444-5838) for instructions and help with calculating research fees for tests and services

Budget Negotiation with Sponsor

After performing a cost analysis of your new clinical trial and a review of the budget provided by the sponsor, the CTO can handle sponsor negotiations concerning the study budget for you.