Clinical Trials at La Trobe
Clinical Trials Governance Framework
La Trobe University is committed to ensuring that its clinical trial activities are conducted with appropriate institutional oversight and in a manner that encourages valuable outcomes through robust trial design that supports research integrity and compliance.
La Trobe staff and students must inform the Ethics, Integrity, and Biosafety (EIB) team about any clinical trial they are involved in on La Trobe premises or conducted at other sites (e.g., hospitals, private clinics, other universities, research institutes, or sites within the community).
Prior to La Trobe University staff and students initiating or agreeing to participate in clinical trial-related activities, the following must be considered:
- who the Sponsor of the Clinical Trial will be (in most cases this will be the institution administering the funds);
- potential risks and benefits to the University;
- potential risks and benefits to participants and the wider community;
- agreement of supporting schools, collaborating organisations, and the University asset managers and, if applicable, a site-specific assessment conducted in accordance with associated policies and procedures;
- study documentation covering the following study feasibility points:
- the appropriate management of work health and safety responsibilities;
- the proposed contractual and legal arrangements;
- insurance and indemnity responsibilities;
- the Sponsor’s requirements;
- ethical and regulatory requirements;
- financial requirements;
- sourcing of any materials or equipment to be used in the trial;
- proposed locations of trial sites;
- required training for staff and students involved in the trial;
- any involvement of international trial sites and/or partners.
Where appropriate, the La Trobe Coordinating/Principal Site Investigators will seek advice from the EIB team and the La Trobe Clinical Trials Platform as early as possible in the project's development stages.
What makes a research project - a clinical trial?
The World Health Organisation defines a clinical trial as ‘any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes’. 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 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: