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?
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?
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.
The Australian Clinical Trial Handbook provides guidance on the legislative, regulatory and good clinical practice (GCP) requirements when conducting clinical trials in Australia using ‘unapproved’ therapeutic goods.
If you wish to provide feedback or contact the team at the NSW Regional Health Partners Clinical Trials Roadmap please email firstname.lastname@example.org
New South Wales Regional Health Partners respectfully acknowledge Aboriginal people as the past, present and future traditional custodians of the land and recognise their continued connection to land, waters and culture. We aim to partner with the Elders, community members and community controlled health services to improve health outcomes for Aboriginal people.