Consumers

• Involving consumers in the concept development and design of your clinical trial is important. Consumers can help define the research question and focus research on outcomes that are important to them. This is especially important in groups of consumers who are less likely to be involved in research (e.g. ethnic minorities, young and working age people, older people, disabled people, people with learning difficulties, those without a university level education, people from lower socio-economic backgrounds).
• Many funding agencies require involvement of consumers in the co-design of clinical trials as there is evidence of the positive effect consumers have on recruitment and retention in clinical trials
• The National Clinical Trials Governance framework will require health service organisations to establish partnerships with patients, carers, families and consumers in the design, and evaluation of clinical trial services.

NSW Health Early Phase Clinical Trial Scheme

In NSW all early phase clinical trials should be submitted to one of the two NSW Health Early Phase Clinical Trial HRECs for review and approval before it can be accepted by a NSW Public Health Organisation (PHO) site. Bellberry Limited have been appointed to provide scientific and ethical review of early phase clinical trials involving adults equal to and greater than the age of 18 years. Sydney Children’s Hospital Network HREC have been appointed to provide scientific and ethical review of early phase clinical trials involving only children and young people under the age of 18  or combined paediatric and adult trials involving children and young people under the age of 16 and young adults up to the age of 25. 

Equity of access

• Equitable opportunity to access and participate in clinical trials for all patients is an important consideration when setting up your clinical trial.
• Almost 32% of Australians live outside of capital cities and people living in rural, regional and remote areas of Australia experience poorer health outcomes; by including patients in rural, regional and remote areas of the community you may improve health outcomes and life expectancy. Other benefits may include improved recruitment and retention and diversity in the participant population.
• Early collaboration with clinicians and clinical units across your rural, regional and remote communities should be considered as an important mechanism to improve access to clinical trials. Collaboration will help build clinical trial capacity by providing valuable mentoring and supervision to clinicians and sites who have little or no experience in delivering clinical trials.
• Information about teletrial conduct can be found in the following sections: ‘Test your Idea’ and ‘Ensure Supporting Documentation is In Place’.

Site Specific Assessment Considerations

• • The investigators have the necessary skills, training and experience to undertake their role, and where necessary, appropriate training and supervision have been arranged;
  • There are suitable and adequate facilities and resources for the project to be conducted at the site as proposed, and they are available for the duration of the project; these include:
    • Physical resources
      • Does the organisation have the appropriate facilities, infrastructure available to support the conduct of the clinical trial?
      • where will your clinical trial take place?
      • where will patients be treated?
      • Do you need storage space for supplies?
      • Is office space for trial staff required?
    • Staffing
      • Are staff required to undertake the clinical trial?
    • Supporting Departments
      • Are supporting departments aware of the trial and supportive of its conduct?
      • Is an Access Request Review required?
    • External providers
      • Do you need to utilise external providers to supply necessary facilities, resources, staff or infrastructure to support the conduct of your clinical trial?
    • Financial considerations
      • Is the budget adequate to undertake the research?
      • The project has been costed appropriately and there are sufficient funds to cover the costs of conducting research at the site;
      • Individual service agreements may be required with supporting departments and/or external providers outlining the services to be provided and any costs or fees to be applied for providing the services.
      • Individual service agreements may be required with supporting departments and/or external providers outlining the services to be provided and any costs or fees to be applied for providing the services.
      • The project has been costed appropriately and there are sufficient funds to cover the costs of conducting research at the site;
    • Any legislative requirements, including notification, registration and licence application requirements have been addressed;
    • Adequate indemnity and insurance arrangements are in place for clinical trials.
    • If the project is a clinical trial with an external sponsor(commercial or non-commercial), there is a written agreement known as the Clinical Trial Research Agreement (CTRA) for medicines or Clinical Investigations Research Agreements (CIRA) for devices. The CTRA or CIRA. A CTRA clarifies the obligations, responsibilities and rights of the parties involved in the trial, NSW Health approved the use of standard agreements for this purpose, these are available from Medicines Australia and the Medical Technology Association of Australia .
    • Research documents to be used at the site comply with requirements of the Public Health Organisation (e.g. use of site logo, format, provision of site contact details, specific wording to be used in participant information sheet – such as information relating to pregnancy for documents to be used at Catholic hospitals, signatures required on consent forms).
    • There is ethical and scientific approval for the project and research documents.