Patients at UHN may be asked if they would like to be involved in a clinical trial during their time at the hospital. A clinical trial is a type of research study that is done to help learn about new ways to prevent, diagnose or treat a disease. This type of research involves human beings who choose to participate. There are different types of clinical trials. Some types of clinical trials that occur at UHN include:
- Prevention trials: The goal of these studies is to prevent disease or condition
- Diagnostic trials: the goal of these studies is to better detect an existing disease or condition. Diagnostic studies may also look at detecting a risk of developing a disease or condition.
- Treatment Trials: the goal of these studies is to find better ways to treat a disease or condition.
- Quality of life trials: the goal of these studies is to see how patients are feeling.
Why are clinical trials conducted?
- To improve medicine
- To provide patients with another option
How are clinical trials developed?
Once it has been decided that a clinical trial is needed, a team of researchers will write a protocol. The protocol is like a recipe for the research team. It tells them why, when and how different parts of the study are to be done.
Approving the Clinical Trial
All clinical trials must be approved by a Research Ethics Board before any patient is approached about the study. A Research Ethics Board is a group of individuals with different professional backgrounds that review all clinical trials to make sure that patients’ rights are protected.
Health Canada also has to approve certain clinical trials, such as any clinical trial that is using an investigational product (an Investigational Product is a medication, agent or device that is not yet on the market).
Only approved clinical trials can be carried out at this hospital. Approved clinical trials may or may not be beneficial to the clinical trial patients and approval does not guarantee that there are no risks involved with the clinical trial.
How are clinical trials run?
At this hospital a doctor leads the clinical trial. There is always one main doctor that is responsible for the trial. This person is called the Principle investigator. There are also other doctors and researchers that work with the Principle Investigator and they are called Co-Investigators. Clinical Research Coordinators work with the doctors and the researchers to help organize and run the study and to help care for the clinical trial patients.
Stages of a clinical trial
There are many different stages of a clinical trial. The main stages for most trials are:
- The informed consent: this process involves sharing of information about the clinical trial between the patient and the research team. This process starts from the moment that a patient is first approached about participating in a clinical trial, and continues throughout the study.
- The screening stage: this process involves determining if the patient is eligible to be involved in the clinical trial as dictated by the study protocol. Not all clinical trials are right for everyone. The study protocol will outline what characteristics a patient must have to be involved.
- Active stage: If the patient is found to be eligible they will begin to receive the treatment, agent or procedure being tested.
- Withdrawal stage: this occurs when the active stage stops and the final information is collected about the patient’s experiences during the active phase.
- Follow up stage: this occurs when the research team continues to monitor the patient’s medical progress after they have finished the active and withdrawal phases. Not all clinical trials include a follow up stage. Follow up allows doctors and scientists to see the long-term outcome of the clinical trial.