An equitable opportunity to access and participate in clinical trials is an important consideration when setting up your clinical trial. Diversity in the participant population can help to ensure that your trial results can be applied in the real world.

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

• Will your trial have adequate representation from regional, rural and remote populations?

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.

• Could you use a teletrial to recruit participants from regional, rural and remote populations?

Medicines Australia has developed a teletrials model that is available here. NSW and the ACT Health have the Rural, Regional and Remote Clinical Trial Enabling Program. Other States use the Australian Teletrial Program.

When developing a clinical trial, you should:

• Familiarise yourself with the relevant research regulatory framework e.g. NHMRC National Statement on Ethical Conduct in Human Research (2023) and the Guideline for Good Clinical Practice and the Therapeutic Goods Administration Annotated ICH Guideline for Good Clinical Practice.
• Consider the design of the trial and how to collect the essential data to produce a valid answer to the research question
• Will your site be able to recruit enough participants to answer the question?
  • do you need to consider having multiple sites to recruit enough participants?

• Consider safety and quality of the clinical trial idea
  • What could go wrong while conducting the trial? Will the standard healthcare change while you are running the trial (so that the result of your work won’t have impact on patients)? Will the healthcare system change and make it harder to conduct the trial?
  • Are participants and staff able to be protected during the trial? Has the safety of the intervention you are testing been established?
  • Will you be recruiting participants with specific considerations, for example, children and adolescents, older persons, populations with other specific needs such as intellectual disability or mental illness, diverse cultural and language groups {Culturally and Linguistically Diverse page} and Aboriginal and Torres Strait Islander People {Research Involving Aboriginal and Torres Strait Islanders page}?
  • Deafness Forum Australia has a good practice guide for citizen involvement in health, disability and medical research in Australasia.
• Is your trial the first time a product will be used in humans?
  • 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.