Each year on May 20 we celebrate International Clinical Trials Day, an opportunity to raise awareness of clinical trials and celebrate the important role they play in healthcare.

Each year on May 20 we celebrate International Clinical Trials Day, an opportunity to raise awareness of clinical trials and celebrate the important role they play in healthcare.

International Clinical Trials Day marks the anniversary of what is known as the very first randomised clinical trial. On May 20 1774, James Lind, a ship’s surgeon in the British Royal Navy, conducted a clinical trial to study the effects of citrus fruits on scurvy in sailor. By dividing 12 sailors into separate groups and testing the effect of providing different treatments to each group, Lind was able to provide evidence of the link between fruit and preventing scurvy. Clinical trials have evolved a great deal since and play a vital role in modern medicine.

So what is a clinical trial, how does one work, who can be involved and are they safe? Naomi Knoblauch, Program Manager of HMRI’s Clinical Trials Unit explains.

What is a clinical trial?

Clinical trials are research investigations in which people volunteer to test new treatments, interventions, or tests as a means to prevent, detect or manage various diseases or medical conditions.

They can include testing medical devices, health service changes, medicines, vaccines, preventive care strategies, behavioural interventions, and more.

Why do we need clinical trials?

Clinical trials are essential to the development of new interventions. Without them, we can’t determine whether a medicine is safe or whether a diagnostic test works in a clinical setting.

What are the phases of a clinical trial?

Clinical trials for new interventions are mainly conducted in different phases. If the intervention looks promising in the early phases of a trial when tested in a small number of people, it moves on to later phases that involve more people.

Phase I
Phase I clinical trials are done to test a new biomedical intervention for the first time in a small group of people to evaluate safety. This trial usually involves between 20 – 80 people.

Phase II
Phase II clinical trials are done to study an intervention in a larger group (usually several hundred people) to determine efficacy and whether it works as intended, and to further evaluate its safety.

Phase III
Phase III studies are done to study the efficacy of an intervention in large groups of trial participants (from several hundred to several thousand) by comparing the intervention to other standard or experimental interventions. Phase III studies are also used to monitor adverse effects and to collect safety information.

Phase IV
Phase IV studies are done after an intervention has been marketed. These studies are designed to monitor the effectiveness of the approved intervention in the general population and to collect information about any adverse effects over longer periods of time.

Who can take part in a clinical trial?

Due to the wide variety of trials taking place, almost anyone can take part in a clinical trial. Trials can involve people of all ages, from children to the elderly, and with all types and stages of a disease or condition.

Taking part in a trial is completely voluntary and participants can withdraw at any time.

All clinical trials have guidelines about who can take part, however, most will have inclusion and exclusion criteria to ensure that the trial will produce useful and reliable results and contribute to the safe conduct of the study.

Are clinical trials safe?

Clinical trials in Australia occur in a highly regulated way. There are lots of rules and guidelines in place that determine to protect those people who volunteer to take part.

What happens when a clinical trial is completed?

Once a clinical trial has been completed researchers examine all the information collected during the study.

Researchers can then determine whether the results mean that the new intervention should continue to the next phase of clinical trial, or, when applicable, seek approval for general use by the relevant authorities, such as the Therapeutic Goods Administration (TGA)

Once a new intervention has been proven to be safe and effective, it may become part of standard treatment for the disease or condition.

How do I get involved in a clinical trial at HMRI?

HMRI often advertises the studies currently recruiting volunteers to participate in their clinical trials on our website here. People can also be part of our Research Register, a register of people who have expressed their interest to be involved in research studies and trials and are contacted when they may be suitable for a trial that is wishing to recruit. More information about the Research Register is available here.