Clinical trials are an opportunity to conduct biomedical or health-related research studies on human beings. Prior to a trial commencing, there must be proven efficacy in a non-clinical environment (usually a laboratory) and the trial must be approved by health authorities and an ethics committee. In Australia, the Therapeutic Goods Administration (TGA) is involved in approving clinical trials.
Clinical trials require funding in the form of sponsors. A variety of individuals and organisations can sponsor a clinical trial. These include: pharmaceutical companies, medical organisations, voluntary/charitable groups and some government agencies. Clinical trials can be held in a variety of places, depending on the requirements of the study. Most trials are conducted in hospitals, doctors’ offices, universities, or community clinics.
Clinical trials proceed over a variety of phases. First testing on humans is classified as a phase I clinical trial, and this involves only a small group of participants (20-100). The primary purpose of a Phase I trial is to determine the clinical safety of the therapeutic. A therapeutic must show safety in the Phase I stage before trials can proceed to Phase II. Phase II studies continue to observe safety, whilst also determining dosage requirements and the efficacy of the drug. Phase II trials involve a larger group of participants (50-300). Should a therapeutic be considered both safe and effective after Phase II testing, the study may move on to Phase III.
Phase III trials involve a much larger group of participants than the other stages of testing (300-5000+). Often, a therapeutic which has been approved for sale by the relevant authority (TGA in Australia) will have successfully undergone two Phase III trials before being marketed.
Clinical Trials involving therapeutic goods are regulated by the Therapeutic Goods Administration, which is part of the Federal government portfolio of Health and Ageing.
There are two schemes under which clinical trials involving therapeutic goods may be conducted in Australia: the Clinical Trial Exemption (CTX) Scheme and the Clinical Trial Notification (CTN) Scheme.
The Therapeutic Goods Administration website provides an outline of the two registration schemes, and of the situations in which each scheme applies.
The CTN Scheme is a notification scheme and, as such, no TGA approval is given. While it is advisable for sponsors to wait for the TGA’s acknowledgment letter before commencing the trial, this is not a legal requirement. For more information about this process, click here
Human Research Ethics Committees (HRECs)
All Australian clinical trials which use therapeutic goods that require an exemption under the Therapeutic Goods Act 1989 must be approved by ethics committees. Only ethics committees that operate in accordance with theNHMRC’s National Statement on Ethical Conduct in Research Involving Humans are allowed to approve such trials. Further information about this process can be found on the FAQ section of the TGA website. A copy of the Human Research Ethics Committee legislation is also available on the TGA website.
BioGrid is a not-for-profit company providing a unique IT platform for life science research teams to access and share genetic and clinical research data across multiple organisations in an ethically approved and secure way using the web. It has extensive clinical and research datasets on large patient cohorts for a number of diseases including most cancers, diabetes, neurological disorders such as epilepsy and multiple sclerosis and cystic fibrosis. BioGrid is being used to support clinical trials through prospective collection of commissioned patient clinical and research data, data mining (looking at patterns and exceptions), data analysis (associations between the genetic and clinical data), evaluation in clinical services and quality and audit reports of clinical treatment.
Cancer Trials Australia
CTA is a clinical trial network spread across multiple sites. CTA provides a fully comprehensive oncology clinical trials service that includes the conduct of single or multisite clinical trials, ethics submissions, research governance, clinical development advisory and laboratory assay services. CTA’s strength lies in the collective technical and intellectual expertise of its members and the sharing of their resources.
CogState ClinicalTrials comprises a customizable range of computerized cognitive tasks able to measure baseline and change in all cognitive domains. Specialized tasks can assess attention, memory, executive function, as well as language and social-emotional cognition if required. Our batteries of tasks are used in research and commercial trials to determine the effect on cognition of drugs, devices, nutraceuticals and other interventions in many different conditions, diseases and disorders, and also in healthy volunteers. They are also used in large-scale sports medicine and screening programs where conventional testing is not feasible.
INC Research is a leading global clinical research organization providing the full range of early- to late-stage clinical development services for the world’s biopharmaceutical industry. Our focus is on innovative solutions that reduce cycle times for our customers and accelerate the delivery of life-enhancing drugs to market for the benefit of patients worldwide. As one of the world’s largest global providers of Phase I-IV services, INC Research offers experience spanning more than 100 countries, along with industry-leading patient access and retention capabilities and broad therapeutic expertise, to meet our customers’ clinical development challenges.
Medicines Development Limited (MDL)
Medicines Development Limited (MDL) is a not-for-profit company that specialises in integrating the extensive development skills of its project management team to assist small biotechnology companies to plan and conduct their clinical development programs.
Neuroscience Trials Australia
Neuroscience Trials Australia (NTA) was established in 2001 with support from the Commonwealth’s Major National Research Facilities program and the Victorian Government’s Science, Technology and Innovation (STI) initiative and is Australia’s only clinical neuroscience trials cooperative group. NTA plays a lead role in the facilitation of both commercial and academic clinical trials across investigators, sites and centres for a wide range of clinical neuroscience specialty groups. NTA provides access to key opinion leaders and clinical trial expertise through a range of tailored clinical trials services. NTA is currently local sponsor and facilitator of significant NIH sponsored trials in insulin resistance intervention for stroke led by Yale School of Medicine and a separate trial of a medical device for the interventional management of stroke in collaboration with the University of Cincinnati.
Nucleus Network is Australia’s clinical research centre. The organisation provides specialised clinical research services in Australia for biotech, pharma and medical device companies from around the world.
Since 1993, Quintiles Australia and New Zealand have provided fully integrated services for Phase II-IV clinical studies to the pharmaceutical industry. From offices in five major cities in Australia and a large office in Auckland, New Zealand, hundreds of employees give you responsive service to help you drive your pharmaceutical initiatives. Quintiles’ experience includes studies at about 1,000 different investigator sites since 2004.
RDDT is a privately owned GLP-compliant preclinical safety testing service based in Melbourne. Its GLP-compliant facility is equipped to perform a range of supporting safety studies in various mammalian species to the appropriate regulatory requirements. RDDT’s team is dedicated to developing and providing OECD Principles of Good Laboratory Practice preclinical toxicology and pharmacology services to the biotechnology, pharmaceutical and chemical industries to accelerate the progress of new therapeutics into clinical trials.
TetraQ is Australia’s leading, fully integrated preclinical drug development (CRO) Contract Research Organisation that offers a broad range of high quality integrated and tailored services (ADME, Bioanalysis, Efficacy, Toxicology, Pharmaceutics) globally to biotechnology and pharmaceutical industries.