BUDGETING AND FINANCIAL MANAGEMENT FOR CLINICAL TRIALS

BUDGETING FOR CLINICAL TRIALS

Researchers are responsible for creating comprehensive budgets that cover all expenses related to the conduct of a clinical trial. Past VCH Research educational sessions have focused on budgeting for clinical trials. Slides from these presentations can be accessed here:

• Presentation #1
• Presentation #2

INSTITUTIONAL OVERHEAD

Institutional overhead must be added to the total cost of the research. For more information on institutional overhead, visit the UBC Office of Vice President  Research and International.

INSTITUTIONAL RESEARCH ETHICS BOARD (REB) REVIEW FEES

An initial application fee of $3,000 CAD per application covers the cost of the submission and initial review of the application for an industry-initiated clinical trial.  As of April 1, 2011, an annual renewal fee of $500 CAD will be levied (at the time of the annual renewal) to cover the cost of the annual renewal and other on-going oversight, including amendments and unanticipated events. Refer to the Annual Renewal Update posted here.

The UBC Certificate of Ethical Approval will not be released until the review fee has been received by the UBC REB.

DEPARTMENTAL COSTS

Hospital departments such as pharmacy or the laboratory may be impacted by the conduct of a clinical trial. Below are costings provided by some of the VCH departments that may be impacted by a clinical trial:

• Pharmacy
• Laboratory
• Pathology

TRIAL START UP COSTS

A significant amount of work is performed on a trial before enrollment actually begins. Consider the time spent doing the following:

• Site selection visit
• In servicing staff
• Investigator meeting
• Setting up services with other departments
• Site initiation visit
• Protocol Review
• Source document creation
• REB application and Informed Consent Form development
• Regulatory documents

Note that start up costs are subject to institutional overhead.

PAYMENT TERMS

The following payment term considerations are important to review before finalizing a clinical trial agreement as they relate to the study budget. It is important to understand how Industry Sponsors will make payments for budget items and when invoices are needed.

• Industry Sponsors may specify certain milestones that must be achieved before payment is made. Pay close attention to the timing and requirements of the milestones. Payment schedules may be appended to the clinical trial agreement as a table or may be written as a paragraph within the agreement. Occasionally, initial payment will not be sent until a research participant is randomized. If a research participant is never randomized, no payment will be received and the research team will have incurred costs that will not be reimbursed. The Principal Investigator may consider asking for a reasonable initial payment that will cover the startup costs. This amount should be adequate to cover all costs incurred with initiating a clinical trial in the event that the trial never begins.
• Review the milestone payments. Is payment made on completion of case report forms? That may mean waiting until the monitor has reviewed the case report forms and sent them into data management. Is payment made on completion of a research participant’s participation in the trial? This may delay payments. An ideal schedule will reimburse after a reasonable amount of research participants have randomized or after a certain number of visits are completed so that the study account does not run in a deficit.
• Industry Sponsors may also choose to hold back a portion of payment until all study activities are complete. Ensure that this is not an excessive amount. 10% of the total budget is common.
  Final payment may or may not depend upon waiting until ALL sites are closed or until the database has been closed. Pay close attention to this because it can mean that final payments may be delayed for a long time.

An ideal payment schedule would include the following:

• Non-refundable initial payment that includes REB fee and startup costs
• Regular payments with realistic milestones
• Final payment made upon closure at the institution
• Invoicing permitted for other costs (i.e. equipment, advertising)