When discussing a trial with a potential participant, the discussion will always include the risks and benefits. With trials involving a medicine or drug therapy, there is a risk of side effects and it is essential these are discussed with potential participants before they decide to enroll.
In clinical trials, side effects are called Adverse Events. However, the term Adverse Event is broader than just side effects – it includes all changes from when you start the treatment regardless of whether they are related to the treatment or not. Even if you stub your toe, the bruised toe is classified as an adverse event.
Good Clinical Practice (GCP) defines Adverse Events (or AEs) as “Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can, therefore, be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product”.
It can be overwhelming for potential participants when given the trial information sheet with a list of every possible side effect. It is important to remember two things:
- Every medicinal product has side effects. Even drugs like paracetamol have potential side effects.
- It is highly unlikely that you will experience every side effect listed.
Adverse events are grouped into very common, common, uncommon and rare to help potential participants better understand the adverse event information. Rare side effects are usually experienced by less than one in 1000 participants. The study doctor will explain in more detail about how to interpret this information.
Adverse event information should be discussed in the context of the following:
- The side effects of the disease under study
- The adverse event profile of the standard therapy if you do not participate in the trial
- How the potential side effects may interfere with the participant’s lifestyle. For example, fatigue may be more of a problem for a construction worker than for an office worker.
Your study doctor should explain the above information to you during the consent process, and it is important to ask for this information if it is not covered.
What if new adverse events are discovered?
One of the advantages of a clinical trial is that you are monitored more closely than someone having standard of care therapy. At every visit, you will be asked about any problems you have had since the last visit. All adverse events are recorded and the study doctor will make a judgement about the severity of the adverse event (mild, moderate, severe, life threatening) and whether it is related to the study treatment. This information is sent to the people running the trial (the Sponsor) who collates all the adverse event information from every person taking the drug and updates the safety profile of the drug. The updated safety information is sent out to all sites at least annually. If there is any changes to the information in the participant information sheet, you will be provided with an updated copy and asked if you still want to continue in the study.
If a serious adverse event occurs, such as a person is hospitalised or suffers a life-threatening adverse event, the information about this serious adverse event is sent out to all doctors using the drug within 7 days. This means that your study doctor has the most up-to-date information about the drug at all times and can adjust your treatment accordingly.
Always remember that as a clinical trial participant, you can change your mind at any time, for any reason. But please discuss coming off the trial with the study doctor before stopping the medication. That way, the study doctor will ensure you transition off the study treatment and onto standard therapy in the safest way possible.
Understanding the potential risks of a clinical trial in context of the disease under study and other standard of care treatments is an integral part of the decision to participate in a clinical trial. It should not be scary but is a significant consideration for all potential participants.
For more information about clinical trials, talk with your doctor or contact the nursing staff at Affinity Research on (08) 9242 7640.