Clinical trials for participants

There are two types of participants in clinical trials:

1. first group will be given the trial medicine or device (treatment group)
2. second group will be treated with current treatment of 'placebo' (control group). 

These two groups are then monitored to gather information about the progress of their illness and to check for any new symptoms or side effects. After the information is assessed, researchers can see which group had the better outcome and discuss benefits and risks of the new treatment. 

There is no guarantee that being in a clinical trial will be of benefit, and there may be risks involved. Lots of effort goes into trying to control risks to your well-being and known possible risks must be explained in a Patient Information and Consent Form (PICF) that will be given to you. 

If new risks are learned during the trial, this information must be shared. If you decide to be a part of the trial you can stop participating at any time. As part of the decision-making process, you will be given a chance to discuss the potential risks and benefits with a clinician. You should make a decision only after you fully understand the study and have had a chance to talk to your family and friends.

Participation in research is completely voluntary. Before you make a decision, you will be provided with a full explanation of the clinical trial, both verbally and in writing. Please carefully consider all the information before deciding to participate. If you have any further queries, ask as many questions as needed.

The explanation of the trial or study will include the following:

• information about the trial medication or device and the testing that has been done
• any possible risks and benefits of the new treatment
• type, frequency and risks of any required medical tests or procedures
• how participation in the study differs from the care you would receive outside of the trial
• any alternative treatment options and any treatments that you will not be able to have while you are in the trial.

Researchers and clinicians, commonly referred to as the Principal Investigators (PIs) usually lead clinical trials. The clinical trial team may include doctors, nurses, pharmacists and other health care professionals. This team is accountable for conduct of the whole trial. 

The Human Research Ethics Committee (HREC) ensures all clinical trials are ethically and scientifically reviewed. 

• To help improve knowledge about a disease
• To help develop a potential treatment for a medical condition
• To help other people impacted by the disease in the future
• Potential access to a drug not yet available to the general public
• Access to the medical professionals from the trial team such as a medical specialists
• Clinical trial related care, monitoring, medical tests and assessments in addition to your usual care

Once the medication reaches the clinical trial, the side effects would have already been extensively tested.  However, not all side effects can be known until the medication is used in humans and there may be unforeseen or unknown additional side effects. It is hard to predict in advance whether side effects might occur but even if they do, appropriate care will be given to participants. 

When ready, the results will be made available to clinicians and these may be published in relevant medical journals and publications. Participants can request the results from the Principal Investigator (PI).

Every clinical trial is conducted in accordance with the SA Health Privacy Policy. Your information remains confidential and will not be shared in any publication results. Your consent to share your information with any other organisation is obtained prior to project commencement and can be discussed with your GP or clinical contact.

• You will only be asked to take part in a research project that is appropriate for you
• Participation in a research project is completely voluntary
• Your treatment will not be affected if you decide not to take part in a research project
• You will receive full information about the project
• You may change your mind and withdraw from a research project at any stage without your care being affected
• You are assured that your dignity, rights, safety, confidentiality and well-being will always be respected