What is a Clinical Trial?
A clinical trial is a research study conducted to evaluate the safety and effectiveness of medical treatments, including new drugs, vaccines, and medical devices. These trials are essential in the development of new treatments for diseases like cancer and COVID-19.
Clinical Trials in Australia
In Australia, a clinical trial is a carefully designed research study that aims to discover or verify the effects of one or more investigational medicines, treatments, or devices. These trials are conducted under stringent ethical and regulatory oversight, adhering to both national and international guidelines.
Regulatory Framework
Clinical trials in Australia must comply with the Therapeutic Goods Administration (TGA) regulations, the National Health and Medical Research Council (NHMRC) guidelines, and the Australian Clinical Trial Handbook. These regulations ensure that the trials are conducted with the highest standards of safety, quality, and ethics.
Ethics Approval
Before commencing, all clinical trials must obtain approval from a Human Research Ethics Committee (HREC). This committee ensures that the trial respects the rights, safety, and well-being of the participants.
Phases
Similar to other countries, clinical trials in Australia are conducted in different phases (Phase 1, Phase 2, and Phase 3), each with specific objectives and methodologies. These phases help in understanding the safety, efficacy, and optimal usage of the treatment being studied.
Participation
Australians can participate in clinical trials voluntarily, contributing to medical advancements. Information about ongoing trials is often available through hospitals, universities, and dedicated clinical trial registries. You can find out which trials we are conducting here.
Impact
Clinical trials in Australia have led to significant medical breakthroughs, including new treatments for diseases like cancer and COVID-19. They play a vital role in improving healthcare outcomes and contribute to the global scientific community. Follow this link to see our past research and the impact Paratus has made
Funding and Support
Various government bodies, research institutions, and private organizations fund and support clinical trials in Australia. This collaborative approach fosters innovation and accelerates the development of new medical solutions.
Phase 1 Clinical Trials
This is the first stage where a new treatment is tested on a small group of volunteers. The main goal is to assess the safety, dosage, and side effects.
Phase 2 Clinical Trials
In this phase, the treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3 Clinical Trials
This phase involves even more participants, often in the thousands, to confirm the treatment's effectiveness, monitor side effects, and compare it with standard or equivalent treatments.
