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 (2007) – Updated 2018 and the Guideline for Good Clinical Practice and the Therapeutic Goods Administration Annotated ICH Guideline for Good Clinical Practice.
• Check that the question hasn’t been answered before. It may seem strange, but a clinical research question has often been answered before, in another location, and sometimes a considerable time in the past. Finding similar research might help refine your question or reveal hints to overcome challenges in your research. Unnecessary duplication of clinical trials is not ethical.
• Consider the design of the trial and how to collect the essential data to produce a valid answer to the research question
• Determine if your idea is practical to implement and acceptable to both health care professionals and consumers? Further information about involving consumers in clinical trial development can be found here.
• 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?
• Equitable opportunity to access and participate in clinical trials is an important consideration.
  • Will your trial have adequate representation from regional, rural and remote populations?
  • Will your trial have adequate representation from culturally and linguistically diverse and Aboriginal and Torres Strait Islander People ?
  • Could you use a teletrial model to recruit participants from regional, rural and remote populations? Steps to establish a teletrial model and site supervision plans are available here.
• 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, and Aboriginal and Torres Strait Islander

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 Unit
• HNELHD Nursing and Midwifery Research Centre offer a consultation service in research design
• There are a number of local registries that provide you with access to consumers and community members who have expressed interest in commenting on design, participating in or contributing to future health and medical research.
• HMRI Data Sciences Group aims to provide comprehensive epidemiological and statistical support to biomedical researchers. Each HMRI affiliated researcher can be provided with an initial consultation of 1 hour free of charge.
• HMRI Health Research Economists Group foster the integration of economic principles and techniques into health research, build regional capacity and expertise in health research economics and to conduct original research of relevance to the field of health economics.
• University of Newcastle Global Innovation Chairs, Research and Innovation Team, Department for Rural Health and the Centre for Rural and Remote Mental Health
• RACGP Expert Committee- Research