What is a clinical trial?

Clinical trials are research studies designed to test new treatments, devices or diagnostic tools that researchers hope will improve outcomes for patients. There are many different types of clinical trial. Some are interventional – for example, asking a patient to take a new experimental drug that researchers hope will potentially have fewer side effects or prolong life compared to existing treatments. Others may be observational, seeking to collect information about how patients respond to other elements of treatment – for example, looking to see whether increased exercise or changes in diet can assist with the management of a particular disease.

Interventional clinical trials will typically follow a structured process that involves four phases of activity and subsequent review.
 
Clinical trials are highly regulated, with the principle aim of ensuring that the rights, safety and well-being of trial participants are protected.

In Australia, clinical trials are governed by the National Health and Medical Research Council (NHMRC) National Statement on Ethical Conduct in Human Research and the NHMRC Australian Code for Responsible Conduct of Research. Clinical Trials involving unapproved drugs or devices are also regulated by the Therapeutic Goods Administration (TGA) who have adopted the international standard for clinical research activities, referred to as ICH-GCP or Good Clinical Practice.

All clinical trials within Ramsay Health Care are conducted by an experienced team that involves medical professionals, nurses, allied health staff and a dedicated clinical trial coordinator. This team of health professionals is there to ensure that all clinical trial activities are run to a high standard, in compliance with the national codes of conduct and, most importantly, to monitor the care of the people enrolled on the trial.

Further information about clinical trials and how they work in Australia can be found from Clinical Trials Australia.