Identify Trial Expenses

The Sponsor-Investigator and central trial coordination team should identify the source of all trial costs during the trial planning stage. 

While applying for grants and writing the trial protocol, identify costs associated with personnel, participants and non-participant related processes/procedures.  Common expenses that are incurred for most trials are highlighted below.

Trial personnel

  • Staff salary costs. See Staffing Costs for further guidance.
  • Does the team need to bring in specific expertise? Will any of these be included as investigators/authors in which case costs may be waived?

Participant-related costs

Any cost directly associated with an individual’s participation in the trial is considered a per participant (or per-patient) cost. 

The per-participant cost is included in the clinical trial agreement between the sponsoring institution and external participating sites. 

To calculate the per-participant costs, factor in the following considerations:

  • Will any of the procedures be considered standard of care (SOC) and therefore be covered by Medicare/PBS?
  • Trial-specific procedures (that are not considered SOC):
    • Obtain costs for each procedure from the relevant supporting department (e.g. medical imaging, laboratories (pathology/anatomical pathology), cardiology, neuropsychology, audiology, pharmacy)

OR

OR

  • Courier services, e.g. shipping patient samples, investigational product. 

Non-participant related costs

Costs necessary for study conduct (incurred whether or not a participant is enrolled) – include:

  • Consumer involvement in trial design, conduct, sharing results - budget for expenses and payments.
    Refer to the VCCC Consumer Engagement toolkit for advice on paying consumers
  • Approvals/Authorisations:
    • HREC & RGO review fees may apply - check with the reviewing HREC and authorising institutions
    • Therapeutic Goods Administration (TGA) - CTN fees if using a medicine or device that is not registered on the Australian Register of Therapeutic Goods (ARTG) or using a medicine/device outside the conditions of its registration). Access the current TGA fee schedule for CTNs here. Note the fees are regularly updated.
  • Trial-specific supplies g. dry ice, lab supplies, equipment
  • Systems set-up (including questionnaire & software license fees, electronic Study/Trial filing)
  • Trial-specific training /Trial start-up meeting - higher cost if getting sites together for multi-site meetings. As a guide for these types of costs, refer to the Independent Hospital Pricing Authority’s (IHPA’s) Determination of standard costs associated with conducting clinical trials in Australia – Standard list of clinical trial items – but note these costs should be interpreted with caution as the costs have not been updated since 2015.
  • Recruitment - advertisements / publicity
  • Data management – if you outsource this to a third party.
  • Statistician expertise – study design plus interim and final analyses
  • Quality assurance monitoring, on-site, remote and centralised. (include staff time, expertise/travel costs)
  • Archiving costs - data and study-level records