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Clinical trials

ECU Clinical Trial Governance Framework

ECU is committed to facilitating world class research and conducting clinical trials is an important component of medical and health research.  Clinical trials evaluate new and/or novel drugs, therapies, interventions and treatments which may improve the health and quality of life of our population.

At ECU, we facilitate various types of clinical trials, including:

  • treatment trials to test new treatments, new medicines or combinations of medicines; or other new therapies; or the use of new medical devices;
  • diagnostic or screening trials to evaluate tests or procedures to diagnose and detect diseases or conditions;
  • prevention trials to test new ways to prevent disease including medicines, vaccines, vitamins, or changes to diet, lifestyle or behaviour;
  • intervention trials to determine effectiveness of health treatments and therapies including diet, exercise, education and psychology.

ECU’s definition of a clinical trial is taken from the World Health Organisation (WHO):

“any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on healthoutcomes”.

The National Health and Medical Research Council provides further clarity to this definition:

Clinical trials are research investigations in which people volunteer to test new treatments, interventions or tests as a means to prevent, detect, treat or manage various diseases or medical conditions. Some investigations look at how people respond to a new intervention and what side effects might occur. This helps to determine if a new intervention works, if it is safe, and if it is better than the interventions that are already available. Clinical trials might also compare existing interventions, test new ways to use or combine existing interventions or observe how people respond to other factors that might affect their health (such as dietary changes).

It is acknowledged that some projects may utilise a similar methodology to that of a clinical trial but not have a specific health outcome, for example an educational strategy. If there is any doubt whether the research should be deemed a clinical trial, researchers can ask the following questions. By answering “No” to any of these questions, the research would NOT be considered a clinical trial.

  • Does the study invovle human research participants?
  • Are participants prospectively assigned to an intervention?
  • Is the study designed to evaluate the effect of the intervention on the participant?
  • Is the effect being evaluated health related, biomedical or a behavioural outcome?
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