a practical guide to the clinical trials journeY


What is the Clinical Trials Roadmap?

The Clinical Trials Roadmap is an interactive and evolving resource that we hope will provide practical advice to understand, develop, plan and start-up clinical trials. The Roadmap sets out key steps, resources and contacts, and we’ve imagined this from two perspectives, two clinical trial

Investigator Initiated Trials

‘I have an idea to improve healthcare, and I want to run a clinical trial

You want to develop your own idea for a trial, but don’t have a pre-existing protocol, funding or a sponsor yet.


‘I have been asked to run a clinical trial by someone else’

You have been approached by an industry sponsor, another academic group or a cooperative research group to be an investigator on their trial to open in your site. This part of the Roadmap will take you to ethics approval and execution of your sponsor’s agreement.

Who is the Roadmap for?

The Roadmap is a resource for researchers and health care professionals who may be new to clinical trials, or who require assistance to plan, develop and conduct clinical trials in a public health organisation.

How to use the Roadmap

In any way you wish! You can use these roadmaps in a linear fashion from start to finish or you can head straight to the section that describes where you are up to in the development of your clinical trial. Not every clinical trial or research project will require all of the steps outlined in the Roadmap, and the steps may not always happen in the same order. Sometimes a step may be skipped, or the order may be altered.

How did this Roadmap come to be, and where is it going?

The Clinical Trials Roadmap was developed in response to a call for clarity around how to create and conduct clinical trials, from multiple partners, including the Hunter New England Local Health District, Hunter Medical Research Institute (HMRI), University of Newcastle and the NSW Regional Health Partners (NSWRHP). With support from NSWRHP and the Office of Health and Medical Research (OHMR), the HMRI CTU has developed this roadmap.

However, maps are not the territory. If you find changes or errors in the current Roadmap, if you have suggestions of better ways to address key challenges in clinical trials, please contact us hmriclinicaltrials@hmri.org.au to provide your improvements, feedback and comments for the next iteration of this living document.

What is a Clinical Trial?

Clinical trials are an essential part of turning health and medical research into drugs and treatments for the wider community with the overall goal of improving peoples’ lives and making healthcare better.

Clinical trials are any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions. These may include patient, family, care provider or community level interventions. Clinical trials may test new or existing interventions or observe how people respond to other factors that may affect their health.

Clinical trial interventions include but are not limited to:

  • Surgical procedures
  • Medical treatments and procedures
  • Psychological, behavioural treatments and social interventions
  • Experimental drugs and medicines
  • Diagnostic tests
  • Medical devices
  • Health-related service changes, preventative strategies or educational interventions.

If you are not sure if your study is a clinical trial check out the questions here to find out.