It is important to know what phase a clinical trial is in and what that means for you or your loved one as a potential participant. Find out more about the different phases of testing in a clinical trial.
Observational studies are designed to provide researchers with a better understanding of a condition. Participants do not receive any intervention (e.g., no drug, device, technique or lifestyle approach) in observational studies. These studies instead involve questionnaires and tests that allow researchers to gather more information on the condition and how it affects participants over the length of the study.
For instance, an observational trial may include yearly brain scans, thinking and memory tests, and blood tests for people living with different types of dementia to identify how these conditions progress differently over time.
It is your choice whether you want to join a clinical study. You should never feel pressured to participate. All studies will ask for your informed consent before enrolling you in the study. This means that you are aware of what the study involves, potential risks and benefits, and you have a chance to ask questions. Once you are provided with this information, you can choose to enroll in the study by giving your informed consent. This may involve signing a form virtually or in person.
In cases of advanced dementia where the person is unable to provide consent, a substitute decision-maker may be asked to give consent on the person’s behalf. Substitute decision-makers are family member(s) or someone close to the person living with advanced dementia appointed to make health decisions for them.
Clinical studies can vary in length from months to years depending on the study plan created by the research team. If you no longer want to be part of the study at any point, you are free to leave and withdraw your consent.
The informed consent process, study plan, and other materials used in a study are reviewed by Research Ethics Board(s) at the hospital and/or university where the studies take place. The Research Ethics Board makes sure that participants are protected and risks are limited. Finally, it is important to note that your clinical care will never be affected by your decision to participate, or not to participate in research.
Find out more information about clinical studies.
Clinical research is a key way for researchers to advance our understanding of diseases. This is particularly important for conditions that we don’t know much about, or that don’t have treatments or cures. Depending on the type of study, the outcomes can help to improve the diagnosis, prevention, treatment, management and/or our knowledge of conditions. Clinical studies can also help researchers test and eventually develop new treatments, such as drugs, medical devices and lifestyle interventions.
To date, in Canada, there has not yet been an approved treatment that can stop or slow down the course of dementia. This does not mean that the field of clinical dementia research has slowed; quite the opposite. Getting involved in dementia research means that you can help researchers find new treatments and better understand dementia. Even when a treatment is found not to improve dementia symptoms in a clinical trial, it still provides researchers with key insights that can help them focus in on what might work (e.g., changing doses, length of treatment or the type of intervention).
For participants, clinical research can also provide you with access to treatments or medical testing beyond what is available from your healthcare provider. This can include interventions not approved by Health Canada, or brain scans and other tests not covered by the Ontario Health Insurance Plan (OHIP).
Being involved in a clinical trial can help researchers prevent, treat and/or better understand dementia. In clinical trials, you may receive a drug, medical device or lifestyle intervention that can help with your memory problems; however, there is also a chance that the treatment may not work or may lead to side effects. It is important that you understand what the study involves, the potential risks and benefits, and to have all of your questions answered before making your decision.
A number of helpful resources can help you make an informed decision about participating in clinical research, including: