Clinical Trial Research Contracts & Budgets

Barwon Health has an outline of minimum standard fees that can be used as a guide for reviewing and negotiating Clinical Trial Research Budgets. Standard Fees are fees that cover the resourcing required to manage a study that are not included the per patient payment schedule. Examples of these fees include set up fees, training, annual administration and fees for ethics and governance review.

For advice and guidance relating to standard fees and research budgets, contact Bree Sarah, Research Operations Manager, at bree.sarah@barwonhealth.org.au

To view and download the standard fees for Barwon Health supporting departments, please refer to Part 2: Standard Fees for Clinical Trial Research below.

Please ensure you use the fees listed for budget negotiations for any Clinical Trial Research and note that the overarching Barwon Health set fees are the minimum required to be included. You should use the protocol and other study related documents as an estimate of the time and resourcing required to manage the conduct of that particular trial at Barwon Health and therefore reserve the right to request more than the fees listed.

Per Participant Payments, or Per Patient Payments, are payments that cover the work required to perform participant study visits according to the protocol and other study related documents.

They are usually, and most conveniently, represented as a direct copy of the schedule of events listed in a study protocol. Like the schedule of events, the Per Participant Budget should have a table that lists tasks performed in the first column versus the visits when that task must be performed across the top row. Download an example of a study budget template in excel here.

There are then two methods that may be used to determine the overall cost of the per participant visit.

Method 1: Each cell in the budget will include the cost of the item (that is the task or procedure performed) and well as a unit of time to complete the procedure by the designated person. See the below example for a blood collection.

In this example: * the item/procedure cost is for the consumables to collect the blood; ^ The Research Nurse is collecting the blood with an hour on cost rate of $80/hour. All values are examples only.

Method 2:  This method is where each cell outlines the cost of the item only (task or procedure) against the frequency, and time for the entire visit is allocated as a separate line item in the budget. Here time required for the visit is often broken down into the research team members who need to perform specific tasks at each visit and usually includes time for the following: Clinical Trial Coordinator/Research Nurse; Investigator of Sub-Investigator and Data Entry. The base rates for these roles can be obtained from the Barwon Health Set Fees document available in Part A. It is essential to review the tasks required for each visit and the time allocated for each team member to perform the task to ensure there is adequate resourcing to conduct of the trial by the research team.

Each of these methods is acceptable in developing or negotiating your per participant clinical trial research budget. The most important component in any negotiation is ensuring resources have been accurately estimated, and preferably over estimated, before the budget is agreed to. The following documents should be reviewed to determine the resourcing requirements:

• Final Study Protocol
• Study Manual
• Laboratory Manual
• Electronic Case Report Form (eCRF) completion guidelines
• Outline of Training Requirements

Where support from another Barwon Health department is required or a third party provider, such as local pathology, you must either obtain a quote for the trial or discuss the cost and resource implications for the supporting department. This is to ensure that any costs incurred by the supporting department are covered in the final budget and they can be remunerated accordingly for the role in the project.

Most clinical trial research projects include a list of items that can be paid for if needed during the course of the clinical trial. These are called pass through cost. These types of costs can include, but are not limited to:

• Protocol specific local laboratory tests
• Procedures performed by other Barwon Health Departments, or specialist providers
• Pharmacy Fees
• Per Participant Travel
• Advertising or other promotional material

These items usually require approval from the funding provider or commercial sponsor before the service is employed, and wording in the Clinical Trial Research Agreement (CTRA), will usually be included to reflect this requirement. Approval from the funder is usually a request in writing, via email outlining the type of service and cost.

Consumer Price Index:

All Clinical Trial Budgets should include an increase for Consumer Price Index (CPI), which varies per quarter. At the time of negotiation should include the Health CPI increase from the current year budget assumptions or similar. If you need further advice, please discuss with your finance business partner.  While CPI is usually included in budgets, the incremental increase isn’t necessarily paid with each year without requesting this from the sponsor or funder. Consequently, when managing your study payments ensure this increases annually and is paid as required during the course of the trials.

Resourcing & recruitment:

Evaluate the resources you will need to recruit to target in the time period estimated for the trial. This will include research team personnel, and may also include advertising, mail out costs and additional administration support. Ensure you negotiate your costs into your budget based on the requirements you have estimated. A recruitment plan is helpful in demonstrating your approach to recruitment, the processes and resources required to meet your target number of participants within the specified timeframe. As a site that recruits to target within this timeframe, you are prioritised as a site for future trials. However it also provides guaranteed income for that particular trial and supports ongoing resources you have allocated to manage the trial.

Endpoint Driven or Long Term Studies (LTS):

The budgets for endpoint driven or LTS clinical trial research projects, often look impressive with a total income of several hundred thousand dollars to be paid to site over the course of the trial. However, the length of time taken to reach the endpoint is an estimate and there are two possible scenarios.

• Scenario 1: The endpoint is reached early, and the income budgeted over several financial years is cut short as the study closes early.
• Scenario 2: The endpoint is not reached within the expected time and the contract requires renegotiation beyond the initial length of the trials.

The greatest risk with Scenario 1 is potential loss of income. Therefore, for endpoint driven trials, where possible, it so worth ‘front loading’ the per patient budget. Fair market value is often compared between clinical trials sites, which is the total cost of performing a trial at each site. ‘Front loading’ refers to negotiating the per patient fees to ensure a higher proportion of the total per participant budget is paid in the earlier visits of the trial i.e. increasing the fees for screening, enrolment, and the first year of the clinical trial research project and reducing fees for visit nearing the end of the trial reduces the risk for these projects. This means later payments will be less, but it minimises the overall total loss of income if a trial finishes early.

Studies that ‘Align with Standard of Care’: 

Many studies are presented as ‘a few procedures’ in addition to standard of care, and are consequently considered to be performed along side routine practice. For these trials, joint review of the protocol requirements with Clinician, NUM or Clinic Nurse with the Research Team (Principal Investigator, Clinical Trial Coordinator, and Research Nurse) should be performed, to allocate which items are standard of care and which item in the protocol are in addition to standard of care.

All items that are additional to standard of care should have a line item in the budget and a resource cost allocated to collect the data from the standard of care system. For example, a diabetes patient is enrolled in a clinical trial and has blood work completed as part of their routine outpatient appointment. This data has been approved for use as part of the clinical trial data and the trial coordinator is required to source it, have it reviewed by the principal investigator and then enter it into the electronic Case Report Form database. An estimate of the time taken to collect this data from its original source, reviewed by the investigator and enter it into the trial database, should be included as a cost in the overall study budget.

It is essential to develop a per patient visit/payment tracker, as well as an invoice and expense log to ensure you are being remunerated for all of the cost incurred and visits performed as outlined in the budget and contract. Payment for these can be then marked off as invoices are raised against the items and payments received for the expenses incurred.  These can be developed in excel.

You may need to establish a Specific Purpose Fund (SPF) cost centre to support the financial management of your project. Some smaller trials may not require a new cost centre, however when revenue goes into an operational cost centre it is challenging to roll over unspent funds at the end of the financial year. It is best person to discuss your financial management and cost centre requirements with your finance business partner. The finance partner for your Directorate and their contact information can be found on the Finance OnePoint page.

The Instrument of Delegation (IoD) outlines the governance responsibilities and accountability requirements for the financial management of Barwon Health in accordance with legislative requirements. It specifically outlines spending and invoice limits for positions in the organisation. All expenditure and budgets at Barwon Health must comply with the IoD, which is available for download via Prompt.