What is a clinical trial? | Stem Cells Australia | What is a clinical trial? | Stem Cells Australia

What is a clinical trial?

Before a new treatment can be made available to patients, it should be tested in clinical trials.

This is an internationally accepted process to minimise potential risk to patients, evaluate the effectiveness of the treatments, figure out the proper dose, and uncover any potential side effects.

How are new treatments
developed?

Are there different types of clinical trials?

Clinical evaluation of a new treatment or drug usually involves several phases of where progress through each phase is based on positive findings from the previous phase. Each phase is designed to answer specific questions. If you are contemplating participating in a clinical trial it is important that you fully aware of the purpose of the study, including potential benefits and risks.

Phases of a Clinical Trial

Image courtesy of the Cancer Institute NSW

Before a new treatment is tested on humans the proposed treatment is first investigated in animal and laboratory tests (preclinical studies). The first phase of clinical trials usually involves only a small number of people and is primarily conducted to test if the new treatment is safe.

If the treatment is promising, they can move on to later phases of clinical trials which usually involve a larger number of patients to test the effectiveness and potential side effects of the drug or treatment. The last phase is usually an ongoing phase after a treatment is approved and available to patients, so they can continue to monitor the effectiveness, and collect more information on any undesired effects.

It can take many years to properly evaluate a proposed treatment through these phases. Many proposed treatments do not pass the later phases of clinical testing. Just because something worked when tested on rats or in a lab, it doesn’t automatically mean that it will work as well in patients.

Who or what regulates clinical research?

In Australia, and in most countries around the globe, there is a requirement that clinical trials are reviewed by an independent committee prior to starting in order to make sure that the approach to be tested has sufficient scientific merit and that the interests of the participants are appropriately taken into consideration.

This is usually undertaken by an ethics committee at the hospital or facility where the trial is being conducted. There is also a requirement for the trials to be registered in an easily accessible database so that patients, doctors and other researchers are aware of what clinical research is underway and who to contact to find out more.

The ANZCTR (or Australian New Zealand Clinical Trial Registry) is the online registry of all clinical trials being undertaken in Australia and New Zealand. You can also search for clinical trials happening in other countries on clinicaltrials.gov, administered by the National Institute of Health in the United States of America.

Please be aware that registration on these sites is not heavily scrutinised, and often relies on an honour system. This means that some stem cell clinics have begun using these platforms as a way to lend legitimacy to their unproven treatments and the claims they promote. These studies will often describe themselves as “patient-funded,” “self-funded,” or “patient sponsored,” and require that patients pay for their participation in the trial.

As a participant in a clinical trial you are not usually expected to pay to participate. Rather your costs, and that of any complication, should be covered by those conducting the trial.

What is a clinical trial?

What is a clinical trial? | Stem Cells Australia | What is a clinical trial? | Stem Cells Australia