NSW Health have developed the NSW Budget Costing Tool and User Guide to facilitate the process of study costing for research being conducted by NSW Public Health Organisations.

Your organisation may have a schedule of standard tariffs that are applied across trials. Please check with your Research Office if they have a schedule of standard tariffs you are required to use.

There will be costs associated with communicating with participants you recruit to the trial, outside clinical requirements. For example, providing your site participants with newsletters; birthday cards; or a lay summary of the research. The latter will be some time after the final participant from your site has completed trial activities, so there is a need to keep the site open and participant contact details up to date until this occurs. CT:IQ has a toolkit on participant communication plans you can use in your discussions with the site Sponsor.

Commercial Clinical Trials

•  Establishing an accurate  budget for your clinical trial will ensure all study protocol requirements are identified and costed. You will need to identify the resources and cost each of the study protocol requirements to conduct your trial e.g. clinical staff time, nursing time, bedstay, shipping, storage, tests and investigations, any overhead margin and in-kind support. Some procedures or investigations included in a clinical trial may be deemed standard of care and are not chargeable when these procedures or investigations form part of a clinical trial. Any research associated costs additional to the standard procedures (e.g. recording of standard of care laboratory results) are still chargeable.
• A carefully prepared budget will help you to compare the budget offered by the Sponsor with the actual cost of conducting the clinical trial at your site and facilitate negotiations so your site receives full reimbursement for the cost of the study from commercial sponsors.

• It is important to understand if the proposed budget covers the actual cost of the trial (including staff, resources and overheads)?

• • When preparing your budget consult with relevant supporting departments (e.g. Radiology or Pathology) and other external providers to:
    • check if services can be provided and if there are any requirements for service agreements.
    • ensure there are no competing interests
    • identify where costs may be incurred

• Does the proposed budget need to be negotiated or renegotiated?
• Who needs to be involved in the negotiations? Consider if any collaborators, the host organisation and any supporting departments should be involved in budget negotiations.
• Does the budget cover assessment of people who do not meet the trial criteria, or only those successfully recruited?

Non-Commercial Clinical Trials

• Establishing an accurate budget for your clinical trial will ensure all study protocol requirements are identified and costed. This process ensures the organisation is aware of the true cost the study to the institution, including any financial and resource implications, including funding shortfall.
• You will need to identify the resources and cost each of the study protocol requirements to conduct your trial e.g. clinical staff time, nursing time, bedstay, shipping, storage, tests and investigations, any overhead margin and in-kind support.
• There is often less scope for negotiation of the budget with non-commercial Sponsors and organisations identify other inherent value that comes from participating these clinical trials where there is a funding shortfall identified. The financial and resource implications, including funding shortfall will need to be clearly articulated in the Site-Specific Application with any strategy that will be applied by the Investigator to address this.
• Does the budget cover assessment of people who do not meet the trial criteria, or only those successfully recruited?

Who Can Help

• Calvary Mater Newcastle Research Office
• Central Coast Local Health District Research Office
• Hunter New England Local Health District Research Office
• Mid North Coast Research and Knowledge Translation Uni