Clinical trials require special budgetary considerations. The process by which a budget is developed depends on whether it is industry or non-industry sponsored. The CTO's Budget Officers work closely with investigators and research coordinators to identify all expenses incurred by clinical trial activity. This will ensure that enough money is requested at the time of proposal preparation or contract negotiations. In addition, the Budget Officers ensure that standard of care costs are identified on both government and non-government sponsored trials so that they are billed to the appropriate third-party provider.

Research Patient Care Costs are the costs of routine and ancillary services provided by hospitals to individuals participating in research programs. The costs of these services normally are assigned to specific research projects through the development and application of research patient care rates. Research patient care costs do not include: (a) the otherwise allowable items of personal expense reimbursement, such as patient travel or subsistence, consulting physician fees, or any other direct payments related to all classes of individuals, including inpatients, outpatients, subjects, volunteers and donors, (b) costs of ancillary tests performed in facilities outside of the hospital on a fee-for-service basis (e.g., in an independent, privately owned laboratory) or in an affiliated medical school/university based on an organizational fee schedule or (c) the data management or statistical analysis of clinical research results.

Standard of Care Costs (aka Usual Patient Care Costs) are items and services (routine and ancillary) ordinarily furnished in the treatment of patients by providers of patient care under the supervision of the physician or other responsible health professionals. Such items or services may be diagnostic, therapeutic, rehabilitative, medical, psychiatric or any other related professional heath services. These expenses are for care that would have been incurred even if the research study did not exist. The patient and/or third-party insurance generally will provide for reimbursement of these charges.

In some rare cases, a sponsor will pay for standard of care costs. For example, reimbursable standard of care costs can be paid when the research hospitalization extends beyond that ordinarily required for usual care, or imposes procedures, tests or services beyond usual care, whether in an inpatient or outpatient setting.

Most patient care costs incurred in clinical trials at Columbia are incurred by NYPH. Such costs are determined by NYPH. For federally sponsored clinical trials, the University is not permitted to pay more than certain prescribed rates for hospital services that are based on agreed upon Medicare reimbursement rates and are discounted from the rate that NYPH would charge non-Medicare patients. The research rates are negotiated with the government on an annual basis and are published in a Chargemaster maintained by the CTO.

There are two discount methodologies that are permitted by the federal government. The University uses the "Ratio of Costs to Charges" or "RCC" methodology that applies a discount rate to each specific hospital service.

When preparing your budget, always contact the CTO for the latest information on costs per patient per service.

Government Sponsored Clinical Trials

The budget for a government sponsored clinical trial is developed in much the same way as a budget for a non-clinical trial. As described in this Preparing a Sponsored Project Budget, the major categories for a government sponsored trial include salary and effort, fringe, equipment, supplies, travel, consultants, subawards and other direct costs. However, "patient care costs" is a category that deserves special attention, thought and planning.

Determining the costs for each of the services required for the study takes extra preparation, and it is highly recommended that these costs be determined as early as possible in the proposal development period prior to the grant deadline. The CTO Budget Officers are kept apprised of all ancillary costs and professional fees.

F&A costs cannot be paid on any cost relating to research patient care costs. When calculating indirect costs for the grant, prior to applying the F&A rate, the research patient care costs should be removed from the total direct costs. For assistance with this, please call your assigned CTO Budget Officer.

Government sponsored clinical trials are subject to the same F&A rate as other federally sponsored projects.  NIH provides specific guidelines for proposal preparation and charging of patient care costs.  For more detailed information, please refer to the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2001/part_iib_8.htm

Industry Sponsored Clinical Trials

A completed budget will be required when the industry contract is ready for review. The CTO will assist in creating a budget with the PI or trial coordinator after he/she provide answers to basic questions regarding the study. To assist in this process, the CTO provides both a budget checklist and a budget worksheet. Both the checklist and worksheet can be found on the CTO website at: http://www.columbiaclinicaltrials.org/online_submission_process.html#CTORequired

Most costs will be determined on a per-patient basis, with the exception of flat fees, such as the IRB and other start up costs. A 33% indirect cost rate will be applied to the total direct costs.