Curtin 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.
The Therapeutic Goods Administration’s university student education materials contain more information on the regulation of therapeutic goods (drugs and medical devices) in Australia.
Clinical trials involving therapeutic goods, whether drugs or devices, that are not yet 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. The Australian Clinical Trial Handbook contains guidance on conducting clinical trials in Australia using unapproved therapeutic goods.
All CTNs must be submitted online via the TGA Business Services (TBS) system. Curtin’s Ethics Office submits CTNs on researchers’ behalf once the clinical trial has received ethics and institutional approval.
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:
- Western Australian Health Translation Network Research Education and Training Program – register to access the GCP online training module
This course meets the minimum criteria for ICH GCP investigator site personnel training identified by TransCelerate Biopharma.
Medical device trials must be conducted according to ISO 14155:2011 Clinical Investigation of Medical Devices for Human Subjects (available through the Curtin Library). This standard is harmonised with the Good Clinical Practice guidelines.
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 ROCemail@example.com or +61 8 9266 9292.