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Clinical Trials Budgeting – Getting our Costs
By Bobby Gatson
The budget specialists in the Clinical Trials Office negotiate budgets with industry sponsors and ensure all anticipated and actual costs of the trial are covered. The budget specialists in the CTO function as an extension of your team. Our goal is to provide you with a finalized budget that meets your needs for completion of the industry clinical trial.
Clinical procedures and laboratory tests are coded costs, which are submitted in our budgets at the Medicare rates. Sponsors can easily search databases and determine that the costs we have input in our budgets for these items are correct and fair market value. While issues come up in negotiations regarding these costs, sponsors usually pay them given that these costs are unavoidable if we are to conduct the study.
Less clearly defined are the labor costs of doing a trial. Nascent labor expenses in doing clinical trials occur, and we can get compensated for them. Arm your budget specialist for TROJAN battle by identifying and justifying those costs. This will ensure that budget negotiations are timely and successful.
It is important to remember that the person(s) working on behalf of the sponsor with the budget are generally not clinical staff and may require detailed information for cost justification. They are often given cost parameters to operate within. If our costs exceed those parameters, we need to provide cogent information that justifies the increased cost.
Here are a couple of things you can do to help facilitate the labor portions of budget negotiations:
- CRFs. If you have the CRFs, provide them to the CTO along with any information that may assist us in budget negotiations regarding labor costs. Frequent issues come up with the timeframe required to complete the CRFs. Discussions can occur with your budget specialist prior to submitting budgets to the sponsor regarding CRF completion.
- Example: Sponsor’s CRF has 3 questions that need to be answered for one section of the CRFs. We have budgeted that it will take 30 minutes to complete this section of the CRF. The sponsor contact’s response to the budget specialist will usually be, “It doesn’t take 30 minutes to input the answers to these three questions.” The Coordinator, prior to submission of the budget, has explained that each of these three question requires gathering information from source documentation. Calculations are then completed with that information, which allows each question to be answered. Thirty minutes to complete this 3 questions, is much more justifiable when the USC budget specialist has this information to provide to the sponsor contact in their discussions.
- Hidden costs. The budget specialist will advocate for payment for items that are not readily identifiable in a spreadsheet. Be sure to capture this and any other costs you would not be completing except to facilitate tasks required by the study protocol.
- Example: Transporting patients from one area to another for protocol required testing. When study participants are required to be in other locations of the building or the campus and you are physically escorting or assisting them to get there, your time for this task should be compensated. You would not be performing this task except for completing work required for the study. Be sure to capture this and any other costs you would not be completing except to facilitate completion of the study protocol requirements.
Please feel free to contact one of our budget specialists if you have industry budget-related questions. They will be glad to will assist you or get you to the appropriate person who can assist you.
Denise Deack (323) 442-7395
Teresa Trejo (323) 442-7396
Bobby Gatson (323) 442-7394