Clinical trials

The information on this page relates to clinical trials, if you are conducting a clinical trial it is important that you understand your role and responsibilities, and you familiarize with the Clinical Trial Governance Procedure.

If you are unsure as to whether the University can be the sponsor of your trial please contact your Research Partnership Manager. Research Partnership Managers liaise with hospitals and external institutions to ensure clinical trial research agreements (CTRA) are in place.

What are clinical trials?

The National Statement on Ethical Conduct in Human Research defines clinical trials as being a form of research designed to find out the effects on an intervention, including a treatment or diagnostic procedure.

A clinical trial can involve testing a drug, a surgical procedure, other therapeutic procedures and devices, a preventive procedure, or a diagnostic device or procedure.

In pharmaceutical and medical device trials there are established codes of good clinical practice that define clearly what is meant by a clinical trial for those purposes.

Human Research Ethics Committee (HREC) review

All proposals to conduct clinical trials require HREC review. HRECs can provide both ethical and scientific review. The responsibilities of the responsibilities and functions of the HREC in relation to clinical trials is detailed in the National Statement on Ethical Conduct in Human Research.

If conducting research in hospitals you should familiarise yourself with the National Approach to Single Ethical Review of Multi-centre Research. For further information please see UQ HREC ratification.

Further information

Please contact the Research Governance Officer or Research Partnership Manager.

UQ Requirements

All clinical trial research undertaken at University of Queensland or by University of Queensland staff or students or visitors must be approved by the University of Queensland HREC prior to commencement. As well, researchers must meet all Commonwealth, State and University requirements.

Protocol

The National Statement requires that all clinical trials be approved by a properly constituted HREC. Applications for HREC review must include a protocol. The NHMRC supports the use of the SPIRIT Statement and Checklist for the development of protocols. SPIRIT is widely endorsed as the international standard for trial protocols.

Risk

Effective risk management increases the likelihood of achieving objectives, identifying and pursuing opportunities and avoiding or minimising unexpected harms. By undertaking a risk assessment researchers can manage risk through risk elimination, avoidance and transfer (insurance). The completion of a risk assessment is mandatory for all clinical trial research.

Insurance

Insurance does not substitute the implementation of robust risk management practices. Clinical trial insurance (this page requires a UQ Login) responds to the potential liability of almost everyone associated with clinical trials undertaken by UQ and its subsidiaries, so long as they are acting within the scope of their duties in connection with the clinical trial. To ensure appropriate insurance coverage, clinical trials must be either declared or notified to UQ's insurer per the more detailed guidance on the UQ Insurance Services website.

Researchers should be aware that adverse events may need to be reported to Insurance Services – please refer to the guidance under the ‘Reporting Adverse Events’ tab on their website.

Please contact the Research Governance Officer or Research Partnership Manager prior to seeking ethical approval.

Clinical trial notification (CTN)

Good clinical practice

Queensland Hospital and Health Services and the University of Queensland require that all researchers undertaking clinical trials must have currency in Good Clinical Practice (PDF, 650 KB) . Training is provided through relevant institutions. Free certificate courses about good clinical practice (GCP) are available (Genesis Research Services, Global Health Training Centre). Please note that Genesis Research Services requires $10 administration fee which provides for a downloadable pdf, which includes all the information covered within the course and is accessible after completion of the training.

Registration

Once approved, research is subject to monitoring and reporting requirements of the reviewing HREC as well as the Office of Research Ethics at the University of Queensland. It is essential that researchers publish their findings at the conclusion of the clinical trial.

Researchers are required to register clinical trials in a publicly accessible register as trial registration promotes transparency, identifies gaps and prevents unnecessary duplication of research.

Monitoring and reporting

The NHMRC has developed Guidance for clinical trials involving therapeutic goods. The guidance covers the following topics:

Data Safety Monitoring Boards
Risk based Management and Monitoring of Clinical Trials involving Therapeutic Goods
Reporting of Serious Breaches of Good Clinical Practice (GCP) or the Protocol for Trials Involving Therapeutic Goods

Please contact Research Governance Officer should you require further information.