Potential benefits and risks
In addition to helping to find better treatments, therapies and diagnostic tests, clinical trials can also provide direct benefits for participants, including:
- The opportunity to be given a new intervention that may be better for your condition or that has fewer side effects than what you are receiving now. Trials may offer participants access to the newest interventions before they are made available to the general public.
- The chance to play an active role in your own health care and gain a greater understanding of your disease or condition.
- Advice, care and support from trained clinical staff who understand your disease or condition.
- Closer monitoring of your condition, care and treatment.
Clinical trials may also be valuable for people with rare or difficult-to-treat conditions for which there may be limited evidence about how the condition is best treated or managed.
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.
While some clinical trials require minimal time and effort from participants, others may require a major commitment and may involve discomfort or pain. Some interventions may also carry some risk. 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.
- The need for additional treatment, tests, hospital visits or complicated medication requirements arising out of your participation in the trial. For example, you may need to keep a symptom diary, collect 24 hour urine specimens or wear a monitor overnight.
- Depending on the type and phase of the trial, unanticipated risks due to limited use or testing of the intervention in humans.
The risks of a specific trial are described in detail in the participant information and consent form as part of the process of informed consent. This process involves one or more members of the research team explaining the risks of participating in the trial, answering any questions that you may have and providing a document that you will be asked to sign before participating in the research.
Potential participants should carefully consider the possible risks and benefits of participation. When considering the risks of a clinical trial, a person might choose to consider:
- what kind of harm may occur;
- how serious the harm may be; and
- what the chance is of any harm occurring.