Medical Research in the Spotlight

COVID-19 has raised public awareness of clinical trials within our community. To address community concerns about research conduct in Australia, we discussed some common research questions with the team at Genesis Research Services in Broadmeadow.

WHO RUNS CLINICAL TRIALS AND HOW DO I KNOW IT IS LEGITIMATE?

In Australia, clinical trials are run by registered doctors and clinical research teams. All clinical trials in Australia are registered on the Australian New Zealand Clinical Trial Registry (www.anzctr.org.au), who ensure the trial meets the required Australian standards.

WHAT ARE THE BENEFITS FOR JOINING A TRIAL?

Clinical trials can offer you free access to potential new treatments. You may also receive first access to new treatments, before they are made available to the general public and contribute to medical development.

For the duration of the trial, you receive close monitoring of your condition, care and treatment from a dedicated research team, including medical specialists, often at no cost to you. You play an active role in your own healthcare and gain a greater understanding of your disease or condition.

WHAT WILL BE EXPECTED OF ME DURING A TRIAL?

Each clinical trial is different. Some are short (one visit), while others may have visits over multiple years. This will depend on the disease/condition being researched and how far through the development process the treatment is. You will be made fully aware of the commitment for each clinical trial, and you have the right to withdraw from the study at any time.

WHAT HAPPENS IF SOMETHING GOES WRONG?

If something unexpected happens during the trial, this is called an Adverse Event (AE). AEs are managed by the doctor, clinical research team, and the provider of the investigational treatment (which may be a pharmaceutical or biotechnology company). Any out-of-pocket costs associated with AEs are generally covered by the trial. The health and safety of participants is paramount.

WILL IT COST MONEY AND/OR CAN I GET PAID?

Cost and payment are determined for each trial. If you are involved in a trial for a potential new treatment, you would expect to be reimbursed for your time and/or travel.

If you are involved in a trial using an approved treatment, you may still be required to pay for the treatment. You may benefit from having a dedicated team closely monitoring your progress and condition.

WHY DO CLINICAL TRIALS SOMETIMES INCLUDE A PLACEBO?

During development, a new treatment is compared to a placebo (a ‘dummy’ treatment) to prove that it works. Sometimes, doctors will use a current treatment instead of a placebo, to prove that the new option works better to treat the condition.

Whether you receive a placebo, the current treatment, or the study product will be chosen at random, and (in most cases), you and your doctor will not know which one you received. This is the gold-standard for medication development.

WHAT SYSTEMS ARE IN PLACE TO PROTECT RESEARCH PARTICIPANTS?

The safety and protection of the participants is ensured by government agencies around the world and human research ethics committees. In Australia, we are governed by the National Health and Medical Research Council (NHMRC). Australia has a global reputation for having experienced medical research personnel producing high-quality research data.

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HOW CAN I BE INVOLVED IN A CLINICAL TRIAL?

Clinical trials can be for specific conditions, or they might need healthy people to join for earlier-stage development. You can reach out to your local doctor, or a dedicated research organisation like Genesis Research Services to register your interest. To view a list of current or upcoming clinical trials here in Newcastle, visit www.genesisresearchservices.com/join-a-trial and register your interest. Alternatively, you may call 4985 1860 and speak to our friendly team.