Clinical trials require time and expertise; so they inevitably require some level of support.

• How much time can you spend on your clinical trial?
• How can you fund this time?
• What are the resources required?
• How much will it cost to conduct the clinical trial?

Commercial clinical trials of novel drugs cost millions of dollars, but some clinical trials can be inexpensive.

• Establishing an accurate budget for your clinical trial will ensure all study protocol requirements are identified and costed. The cost of study activities that are already standard of care (i.e. in-kind support) should be included in the budget as these will inform the affordability of your intervention when implemented in practice.
• 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.
• A carefully prepared budget will also help you to prepare funding applications and adhere to submission guidelines. Consult with relevant supporting departments (e.g. Radiology or Pathology) 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
    
    

• Remunerating or otherwise acknowledging consumers who undertake consumer involvement activities is considered international good practice and should be considered in your budget preparations. Unlike the rest of your team, it is not part of a health consumer’s regular employment to work on your clinical trial. Many consumers are happy to provide their expertise for free, but you should not assume this. If you do not have access to funds to pay them for their time, particularly before funding is sourced, be clear about this. Many consumers will still choose to be involved during early stages if consumer costs are included in grant applications.

  • NSW Health has a Remuneration Factsheet for consumers, carers and community members. This includes an hourly and daily payment rate, which you can include in your budget for consumer involvement in later phases of the research cycle.
  • Make sure you talk to your consumers about how they would like to receive this payment. An honorarium payment directly into their bank account is usually the most transparent method, but some will prefer gift cards or decline payment entirely.
  • Health Consumers NSW provides remuneration and reimbursement guidelines for consumer involvement {Resources for Researchers – Health Consumers NSW}
  • At a minimum, you should offer to reimburse consumers for out-of-pocket costs like transport and parking and provide refreshments for on-site meetings.
    • Don’t forget to provide your consumers with a claim form template {Resource 24 p44; WAHTN-CCI-Handbook_29092021.pdf}
    • Some consumers may not be able to fund these costs upfront, so other arrangements such as cab charge may be required {Reimbursing consumers}.
  • Ensure you include costs for administration time to manage consumer involvement, such as:
    • Preparation of expression of interest, role description and orientation materials
    • Interviewing and then getting to know your selected consumers
    • Taking time to provide orientation to your project, other team members and where you work, including any onboarding requirements
    • Submitting payment forms to your organisation
  • The AHRA CCI Handbook outlines Consumer Involvement Costs and Considerations (Resource 12 p31) 
  • ACTA has a Consumer Involvement Cost Calculator to help cost your involvement activities.

  There will also be costs associated with communicating with participants you recruit to the trial. CT:IQ has a toolkit to assist with developing participant communication Plans.

• It is important to check with the relevant Business Manager and/or Research Office that you have accurately captured the costs for running the trial including any cost associated with the regulatory requirements of study start up.

Who can help?

• Will your clinical trial need access to patients, staff or facilities? If yes, then you should liaise with the relevant supporting departments and your Research Office for any procedures including Access Request Review for required for access to participants, tissue or data.
  • 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 Unit
• Will your clinical trial need university governance approval, facilities or services (e.g. grant administration)? If yes, then you should liaise with your university research Office
  • University of Newcastle Research Office
  • University of New England Research Office
  • Other university governance offices as required
• If you need help navigating the development of your clinical trial, you can engage the HMRI Clinical Trials Unit (CTU) to support you throughout your trial, or in specific areas only. If you require support, consider building service and support costs into your study budget so that you can pay for this support.