Clinical trials

Curtin University Ethics Office uses the WHO / ICMJE 2008 definition of a clinical trial.  That 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.

‘Intervention’ refers to manipulation of the participants or the participants’ environment for the purpose of modifying one or more of the study outcomes.  The intervention may be a drug, medical device, surgical procedure, diagnostic or screening procedure, a health service change, or a psychological, educational or behavioural strategy.

Interventional studies characteristically involve comparison of one or more interventional groups with a control group.

The Association of Clinical Research Professionals offers a free online Introduction to Clinical Trials course.  This one-hour course outlines how medical products are developed and how clinical trial participants are protected.

For a brief introduction to the clinical trials environment in Australia, you may refer to the NHMRC’s clinical trial eLearning modules.  These modules consist of three 45 minute videos providing an introduction to the clinical trials environment in Australia, ethical issues relating to clinical research and research governance processes relating to clinical research.

Further information on the regulation of therapeutic goods (drugs and medical devices) in Australia may be found in the Therapeutic Goods Administration’s university student education materials.

Therapeutic Goods Administration

Clinical trials involving research with therapeutic goods, whether drugs or devices, that are not yet registered, listed or entered on the Australian Register of Therapeutic Goods (ARTG) are subject to regulation by the Therapeutics Goods Administration (TGA).  These regulations also apply to use of a registered or listed product in a clinical trial beyond the conditions of its marketing approval.  There are two schemes under which such trials may be conducted: the Clinical Trials Notification (CTN) scheme and the Clinical Trials Exemption (CTX) scheme.  Please refer to the TGA website for more information regarding the CTN and CTX processes.

From 1 July 2015, the CTN scheme will transition from a paper based to an online format.  From this date, all CTNs must be submitted online via the TGA Business Services (TBS) system.

The Curtin University Ethics Office can submit CTNs on researchers’ behalf once the clinical trial has received ethical and institutional approval.

Good Clinical Practice and ISO 14155

Clinical trials must be conducted in accordance with the Note for Guidance on Good Clinical Practice (CPMP/ICH135/95 – Annotated with TGA Comments), the Good Clinical Practice (GCP) guidelines adopted in Australia.  GCP is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve human participants.

Free online GCP training is available at:

Both of these courses meet the minimum criteria for ICH GCP investigator site personnel training identified by TransCelerate Biopharma.

Medical device trials must be conducted according to ISO 14155 Clinical Investigations of Medical Devices for Human Subjects (available through Curtin University Library).  This standard is harmonised with the Good Clinical Practice guidelines.

Clinical Trial Guidelines

The Principles of Conducting Clinical Trials guideline describes some of the overarching concepts that provide a framework for the design, management and conduct of clinical trials.

Resources available from Curtin University Library:

Fundamentals of Clinical Trials provides further detail on the fundamental concepts of designing and managing clinical trials.

Clinical Research Manual: Practical Tools and Templates for Managing Clinical Research contains practical advice on conducting clinical trials.

A Clinical Trials Manual from the Duke Clinical Research Institute: Lessons from a Horse Named Jim contains practical advice on conducting clinical trials.

Conducting Clinical Research: A Practical Guide for Physicians, Nurses, Study Coordinators, and Investigators contains practical advice on conducting clinical trials.

Business Administration for Clinical Trials: Managing Research, Strategy, Finance, Regulation, and Quality contains information about the business operations related to clinical trials.

 

For assistance in designing and conducting clinical trials please contact Anneli Robbshaw at ORD-clinicaltrials@curtin.edu.au or on +61 8 9266 9292.