CLINICAL TRIALS

A clinical trial is a scientific study, or an organised test of medicines and new treatment options involving patient and non-patient human volunteers. Clinical trials confirm whether medicines are safe and effective to introduce as new treatments for a particular disease or condition.

Clinical trials may also be used to determine whether an existing medicine can be safely and effectively used for other diseases and/or conditions.

While medicines are extensively tested in laboratories, these tests can only predict how a medicine will act. To thoroughly understand how a new medicine actually works in humans, it needs to be tested on people affected by the disease the medicine is designed to help. These human tests (clinical trials) help doctors to assess if the new medicine is more effective or safer than old medicines or treatments, and to determine the correct dosage of the medicine.

Clinical trials are needed to collect data required by the Australia government to demonstrate that the medicine is safe and effective. It is not until this data has been assessed by the Australian government’s Therapeutic Goods Administration (TGA) that new medicines are approved for prescribing by your doctor or hospital and made available for sale at the pharmacist.

Results from clinical trials can lead to the development of medicines that can prevent thousands of deaths each year and also improve the lives of thousands more people suffering from various medical conditions. How are clinical trials approved?

In Australia, clinical trials must conform to the Ethical Principles of the Declaration of Helsinki and to international Good Clinical Practice guidelines. Before a trial can go ahead it needs to be approved by independent ethics committees that operate according the guidelines issued by the National Health and Medical Research Council (NHMRC Guidelines).

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