Definition of a clinical trial and their regulations
What is a clinical trial?
Clinical trials are an essential part of developing new treatments. A clinical trial can help researchers investigate a potential new treatment, diagnostic test, device to evaluate the safety and effectiveness of new medical treatments, interventions, or procedures.
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.
Before commencing all clinical trials must obtain approval from an independent Human Research Ethics Committee. Ethical approval is a critical step in the process of conducting clinical trials to ensure that research involving human participants is conducted ethically, with responsibility and with due consideration of participant safety, welfare and rights.