Clinical Trial Frequently Asked Questions

General Information

Clinical Trial Frequently Asked Questions

What is a Clinical Trial?

A Clinical trial is a research project in which people volunteer to test new treatments, interventions or tests as a means to prevent, detect, treat or manage various diseases or medical conditions. Some investigations look at how people respond to a new treatment or intervention and what side effects might occur. This helps to determine if a new intervention works, if it is safe, and if it is better than the interventions that are already available.

Clinical trials might also compare existing interventions, test new ways to use or combine existing interventions or observe how people respond to other factors that might affect their health (such as dietary changes).

What are the Potential Benefits of Participating in a Clinical Trial?

By participating in a clinical trial you will contribute to the scientific knowledge about the disease/intervention being studied. Additional benefits may include:

  • Access to the new treatments/interventions before they are made available to the general public.
  • Advice, care and support from trained health professionals who understand your disease or condition.
  • Closer monitoring of your condition, care and treatment.
  • The new intervention may be better for your condition or may have fewer side effects than what you are receiving now.

It is important to note that there is no guarantee that any individual participant will receive any direct benefit from taking part in a trial.

What are the Risks of Participating in a Clinical Trial?

Some possible risks of participation in a clinical trial include:

  • The new intervention in the clinical trial may not work for you.
  • The new intervention may not be as effective as established interventions or standard care.
  • There may be unpleasant, serious or even life-threatening side effects associated with the new intervention.
  • There may be additional treatments, tests or hospital visits.  For example, you may need to have extra blood tests, keep a symptom diary, answer daily questionnaires or attend extra hospital visits.

Before you decide to participate in a clinical trial, the risks and potential benefits will be explained to you and you will have the opportunity to ask questions. You will be given written information called a Participant Information Sheet and Consent Form to read. You may discuss the written information with you family and GP before deciding whether or not to participate.

How do I Leave a Trial?

You may leave a clinical trial at any time. You do not have to give a reason for leaving the trial. The decision to leave a trial will not affect your relationship with your doctor or the institution conducting the research.

Before you leave a trial, you should inform the trial staff to so they can advise you on any effects of leaving the trial, how to leave the trial safely and explain what will happen to any information already collected.  After leaving a trial you should discuss other treatment options with your doctor.

A trial may be stopped if the intervention is found to be unsafe or ineffective.

Where can I Find More Information?

You can download a copy of the NHMRC “Consumer Guide to Clinical Trials” by following this link.

Clinical Trials conducted by Affinity Research are supervised by the Bellberry Human Research Ethics Committees. Bellberry offers information for potential clinical trial participants on their website: http://bellberry.com.au/im-a-participant/information-to-consider If you have any questions or concerns that you do not feel comfortable discussing with your doctor or with an Affinity staff member, Bellberry can be contacted on (08) 8361 6222.

For information about clinical trials being conducted by Affinity Research, call (08) 9242 7640 or fill out this form.