Clinical Trial Governance
Clinical Trials are essential in improving the health and well-being of our community, as they produce the best data available for healthcare decision making. Clinical trials can also provide direct benefit to participants by providing them with better treatments, therapies and diagnostic tests. To ensure clinical trials run at, and by, the University of Tasmania (UTAS) are of the highest quality, they are subject to both ethical and Clinical Trial Governance review before starting, and their conduct is to be monitored throughout their lifecycle.
The relationship between UTAS Clinical Trial Governance and ethical review
UTAS Clinical Trial Governance and ethical review are two distinct processes that can occur in parallel.
UTAS Clinical Trial Governance: The institutional consideration as to whether an individual research project is a good fit for the institution at the time it is proposed. This process takes into account the ethical review as well as institution-specific considerations such as resources, budget, risk management and applicable legal, regulatory, jurisdictional and other administrative requirements. In addition to approval to conduct a trial at a UTAS site, trials may also seek approval for UTAS to act as the trial sponsor. All Clinical Trials must have a sponsor, however, this may be the host institution, another institution in multi-center trials or a commercial entity. See below 'Applying for UTAS Clinical Trial Governance Authorisation' for examples of when these instances occur. There are specific responsibilities attached to sponsorship of clinical trials, which UTAS may or may not be willing to take on depending on the trial.
Ethical review: Ethical review assesses the proposed research in the context of the rights, dignity and welfare of participants in research as well as ensuring that the research is scientifically sound and promotes good research. Please refer to the UTAS Human Ethics webpage for further information regarding this process.
The UTAS Clinical Trial Governance process
The UTAS Clinical Trial Governance Process (PDF 96.3 KB) has been established to guide researchers through the process of obtaining UTAS site approval and UTAS sponsorship approval (if required). An infographic (PDF 66.8 KB) of this process has been developed to support researchers.
The Clinical Trial Governance process examines whether the research is appropriate to be conducted at UTAS. It is a site-specific assessment, which means multi-site studies (such as ones that run at UTAS and Department of Health sites) will need to gain authorisation at each site. The UTAS Clinical Trial Governance process looks at issues such as risks of the proposed research, indemnity arrangements, contract review and any other site-specific documents.
The outcomes of the ethical review and UTAS Clinical Trial Governance process together make up the final documentation that is provided to the Deputy Vice-Chancellor (Research; DVCR). These documents collectively allow for consideration of all aspects of the clinical trial governance arrangements and will assist the DVCR's decision on granting authorisation to conduct the clinical trial. Research cannot commence until UTAS Clinical Trial Governance Authorisation has been granted.
Information regarding the Australian Clinical Trials Environment and national initiatives is available on the National Health and Medical Research Council (NHMRC) webpage.
What is a Clinical Trial?
A clinical trial is a research investigation 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. An investigation1 might look at how people respond to a new intervention, for example, and what side effects might occur. This helps to determine if a new intervention works, if it is safe, if it is better than other existing interventions, compare existing interventions or observe how people respond to other factors that might affect their health (such as dietary changes).
The World Health Organization (WHO) definition for a clinical trial is:
'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'.
To break this down into its parts, to be classified as a clinical trial the following must apply to the research project:
- Involves human participants.
- The number of participants is not relevant
- Participants may be either healthy or un-healthy depending on the protocol
- Prospectively assigns participants to a health-related intervention(s) as part of the protocol.
- The intervention is health-related
- The number of interventions is not relevant: clinical trials may involve participants being assigned to one arm (everyone is treated the same) or multiple arms (participants may receive different sorts of treatments such as placebo vs. active intervention)
- Designed to evaluate the effect of the intervention on the participants.
- The effect(s) being evaluated are health-related biomedical or behavioural outcomes.
While there is a widespread perception that clinical trials are solely to do with drug and medical device development, they can involve researchers from a wide range of disciplines. This is largely due to the range of research activities that may be classed as a “health-related intervention1”, including:
- experimental drugs;
- cells and other biological products;
- medical devices2
- surgical and other medical treatments and procedures;
- psychotherapeutic and behavioural therapies;
- health service changes;
- preventive care strategies; and
- educational interventions.
Researchers may also conduct clinical trials to evaluate diagnostic or screening tests and new ways to detect and treat disease.
This definition of a clinical trial is taken from the Australian Government's clinical trial webpage. For assistance in determining whether your research project is a clinical trial, use this decision aid (PDF 74.8 KB)
1The word 'intervention' is used to refer to interventions, treatments and tests throughout this website.
2Note that some apps and software are classified as medical devices by the Therapeutic Goods Administration (TGA). More information can be found at the TGA website.
COVID-19: Guidance on clinical trials for institutions, HRECs, researchers and sponsors is a joint guidance document that reflects the shared views of all state and territory Departments of Health, the Clinical Trials Project Reference Group (CTPRG), NHMRC and the TGA. It is now available on NHMRC’s website.
It provides general information and advice to institutions conducting or overseeing research, Human Research Ethics Committees (HRECs), researchers and sponsors in the context of the COVID-19 pandemic. It is directed towards those involved in clinical trial research and other relevant clinical research, but also may be of use to institutions, HRECs and researchers in other fields.
The advice represents current thinking and best practice at the government level and will be reviewed and updated regularly to reflect changes in government policy, public health advice and the needs of those conducting and participating in clinical research in Australia.
Insurance and COVID-19
The UTAS insurer for clinical trials has updated the policy to include a COVID-19 exclusion clause. Should a participant contract COVID-19/SARS-CoV-2 as a result of participating in a clinical trial (where the trial is not a Coronavirus-related trial that has been specifically accepted), they would not be covered by UTAS insurance for claims related to that disease.
International Trials and COVID-19
The Principal Investigator for any clinical trial that involves an international site must confirm that, for the international site/s:
- a COVID-19 safe plan is in place;
- the trial PI has sighted the plan;
- the plan is appropriate and that COVID-19 risks will be managed; and
- that the Participant Information and Consent Form (PICF) includes this information.
How to design and run a Clinical Trial
The UTAS Clinical Trial Governance Toolkit webpage includes useful information on how to run a clinical trial, including information about Good Clinical Practice training, Data Management and more. It has a number of templates to support the conduct of clinical trials at UTAS and links to other resources.
Applying for UTAS Clinical Trial Governance Authorisation
If your project is a clinical trial, the next step is to determine what role UTAS is playing.
A clinical trial sponsor is defined as the organisation that takes responsibility for the initiation, management and/or financing of a clinical trial.
UTAS can play one of four roles in a clinical trial:
If non-synthetic therapeutic goods for administration to humans in a clinical trial are imported from overseas, they are considered a biosecurity risk material and require an import permit issued by the Department of Agriculture. UTAS has a valid permit for this commodity, which must be used whenever a consignment of therapeutics is imported.
If your trial involves the use of non-synthetic therapeutics, please refer to this fact sheet (PDF 45.7 KB) for information on how to obtain a copy of the UTAS permit.
Trials involving the Department of Health
If you are conducting the trial at a Tasmanian Department of Health site or clinic, or using data from the Tasmanian public health system, you will need to undergo a research governance review using either the Site-Specific Assessment (SSA) form or the Access Request (AR) form. This is separate from the UTAS Clinical Trial Governance process.
Further information and support
The Department of Health (DoH), Research Governance Policy Framework (RGPF) and governance review forms are available on the DoH website: health.tas.gov.au/research/research_governance, or contact the Department of Health Research Governance Office at email@example.com for more information.
Help and Support
For further information about UTAS Clinical Trial Governance, please contact Clinical.Trials@utas.edu.au.
The College of Health and Medicine (CHM) Research Hub is responsible for facilitating the Clinical Trial Governance process for clinical trials run at, or by, UTAS, and making a recommendation to the Deputy Vice-Chancellor (Research) as to whether the trial should be authorised.
Useful links and resources
- UTAS: Research Integrity and Ethics training
- Australian Government: Australian Clinical Trials – for researchers
- Australian Government: Resources for Clinical Trials in Australia
- Australian Government: Clinical Trials Toolkit
- CONSORT statement: Randomised Controlled Trial
- CONSORT statement: Pilot and feasibility trials
- NHMRC: Research Governance Handbook (PDF) (2011)
- NHMRC: Clinical Trial Reform
- TGA: Integrated Addendum to ICHGCP E6(R1): Guideline for Good Clinical Practice ICHGCP E6(R2) (2016)
- NIH Clinical Trial Protocol template
- SPIRIT Protocol template and checklist
- PRAXIS training: workshops include Clinical Trial Essentials
- ARCS Australia Professional Development in Therapeutics
- TRAJAN: Optimising clinical trials in a commercial context
- Office of the Gene Technology Regulator: Guidance on the regulation of clinical trials involving Genetically Modified Organisms
- NSW Health: Early Phase Clinical Trial Framework for NSW (PDF) (2017)