Clinical Trials at La Trobe

What is a clinical trial?

A clinical trial is a research study that prospectively assigns human participants or groups of humans to one or more health or health behaviour related interventions to evaluate the effects on health outcomes or wellbeing.

Clinical trial decision tool

This clinical trial decision tool will enable La Trobe staff and students to determine whether their research meets the definition of a clinical trial.

If the intervention in the clinical trial involves the use of a therapeutic good that is not listed on the Australian Register of Therapeutic Goods, then the Therapeutic Good Administration Clinical Trial Notification or Clinical Trial Approval Schemes will be utilised.

Research Governance Policies and Framework

The Research Governance Framework is underpinned by La Trobe University Research Governance Policies and Procedures.

The purpose of the La Trobe University Clinical Trials Research Governance Framework is to:

  • provide an outline of the roles and responsibilities specific to clinical trials so that La Trobe staff and students apply a consistent approach is all research activity
  • provide a systematic, hierarchical aggregate of all research activities across campuses
  • ensure legislative and regulatory requirements are met
  • ensure policy mandates, principles and best practice standards are in place.

By doing this we aim to achieve and continuously improve the quality of research across La Trobe from concept to completion.

Clinical trials partnership pathways

The following information provided is aimed at helping understand the clinical trials requirements for:

  • Commercial & Industry Partners
  • University Research staff and students conducting single-site and multi-site clinical trials
  • Professional staff at the University
  • Collaborating:
    • Principal Investigators
    • Ethics & Governance Officers
    • Professional staff
    • Organisations

There are three ways you can partner with La Trobe to conduct clinical trials. The three pathways are referred to as ‘sponsorship pathways’ and outline the roles and responsibilities of each party to ensure a streamlined approach to clinical trials start-up and conduct during the trial.

The sponsorship pathways are:

  1. Commercial and Industry sponsored projects
  2. Projects sponsored by La Trobe
  3. Projects sponsored by other organisations (with a La Trobe collaborator)