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Deciding To Take Part In a Clinical Trial

Information Guide 

Before deciding to take part in a clinical trial, it’s important to learn all that you can about the trial. Talk to your healthcare team and to the clinical trials team. Ask lots of questions so you can make the best choice for your child (hereby referred to as you). 

How you’re protected 

To protect your health, safety and privacy, every trial must follow strict rules and meet high standards from the FDA and Health Canada. Your safety is always being considered and monitored when you are part of a clinical trial. The trial may be stopped if: 

  • The early results of the trial show that the treatment being tested does not work as expected. 
  • Serious side effects occur during the clinical trial. 
  • Early results show that the new treatment being tested works better than standard treatment In this case, all the people in the clinical trial are offered the new treatment. 

Phases of Clinical Trials 

Phase 1 trials are often the first time a new therapy is tested in people. This phase is used to see how safe a treatment is and what the best dose is. There are usually 15 to 30 people in the trial. 

Phase 2 trials are used to show how well a treatment works. They continue to look at how safe the treatment is and what are the possible side effects. There are usually fewer than 100 people in the trial. 

Phase 3 trials compare a promising new treatment to the standard treatment, which is the accepted and commonly used treatment for a condition or a disease. In particular, researchers want to know if the new treatment is better than the standard one. Phase 3 trials may include people from all over the world. The usual number of people in the trial is several hundred to several thousand. 

 Phase 4 trials gather more information on possible effects – good and bad – after a new treatment has been approved for use in Canada. There are usually several hundred to several thousand people in this phase. 

Randomized Clinical trials 

Clinical trials may have different groups in their design. There are 2 groups most of the time, but there can be more. One group is a control group – the people in this group do not get the treatment being studied. The other group is the experimental group – the people in this group get the treatment being studied. 

To make sure that the groups can be compared with each other, a computer will assign each person by chance to a group. You have an equal chance that you will be assigned to the control group or the experimental group. This is called randomization.  

There are 2 types of randomization. 

In blinded randomization, the researchers know who is in the experimental group and who is in the control group, but the people in the study don’t know. This prevents the people in the study from doing things that may affect the study results. 

In double-blinded randomization, the people in the trial don’t know what group they are in, and neither do the researchers. In science terms, this study design is thought to be the best because neither the participants nor the researchers can affect the study results by doing things that they think they should, based on what group they are in.  

Clinical Trials Using a Placebo 

A placebo is a pill or injection that looks like the substance being tested but doesn’t actually do anything. Giving placebos to one group in a clinical trial lets researchers compare the new treatment to the placebo. Placebos are not given instead of effective standard treatments. For example, a trial may compare a new treatment that is given along with the standard treatment to a placebo given along with the standard treatment. This tells researchers whether the new treatment is effective.  

Placebos are given in trials that are double-blinded. You will be told if a trial does use a placebo, but you won’t know if you’re in the group receiving it and neither will the researchers.  

Understanding the Trial and Informed Consent 

Before you decide to join a clinical trial, you need to understand the protocol. A protocol is a written description of the trial. It explains why the trial is being done, how it will be conducted and how your safety will be protected. 

The protocol will also include information on: 

  • who can participate in the trial (eligibility) 
  • how many people will take part in the trial 
  • what type of treatment will be given and how often 
  • what medical tests you will have during the trial and how often 
  • how long the trial is expected to last 
  • how the researchers will know if a treatment is working  
  • what type of information will be collected and how the information will be analyzed 

Where clinical trials are held 

A clinical trial usually takes place in the same location where standard treatment is given –hospitals, clinics or doctors’ offices. While some trials enroll people at 1 or 2 locations only, a large clinical trial may involve thousands of people at hundreds of locations across the country or around the world.  

The clinical trial team 

Clinical trial teams are made up of doctors, nurses, pharmacists, research assistants and other healthcare professionals who are trained in clinical medicine and in proper conduct of clinical trial research. The person in charge of the clinical trial, usually a physician, is called a principal investigator.  

A clinical research associate or clinical research nurse on the team is there to help support you during treatment. This includes answering your questions, monitoring your health during the trial and helping you understand what will happen during the clinical trial.  

Informed consent 

You should be given all the facts about a clinical trial before you decide to take part. This important process is known as informed consent. 

People interested in taking part in the study receive a printed consent form that outlines key facts about the study. These include details about the treatments and tests and any potential benefits, risks or side effects. 

If you agree to take part, you will be asked to sign the informed consent form. Even after you have signed an informed consent form, you can withdraw from participating in a clinical trial at any time 

Deciding to be in a clinical trial 

Choosing to participate in a clinical trial is a personal decision, and your reasons for signing up may be different from someone else’s. It may help you feel more actively involved in the decisions about your treatment. When you are in a clinical trial, you are part of the research that could bring new hope to others, maybe even your own family and loved ones. 

Learn all that you can about the trial 

Before deciding to take part, it’s important to learn all that you can about the trial. Talk to your healthcare team and to the clinical trials team. Ask lots of questions so you can make the best choice for you. Make sure that you understand the: 

  • type of trial 
  • risks and benefits 
  • costs and time involved 

How you’re protected 

To protect your health, safety and privacy, every trial must follow strict rules and meet high standards.  

Your safety is always being considered and monitored when you are part of a clinical trial. The trial may be stopped if: 

  • The early results of the trial show that the treatment being tested does not work as expected. 
  • Serious side effects occur during the clinical trial. 

Leaving a clinical trial 

Taking part in a clinical trial is voluntary. You may leave the trial (this is called withdrawing your consent) at any time. This doesn’t mean that you won’t be treated any more. You will still be given the best standard treatment after leaving a clinical trial. 

The clinical trial team may also take you out of the trial if they have concerns about your safety and well-being. 

If you do decide to leave a clinical trial, let the clinical team know that you are leaving and why. 

Costs 

In most treatment trials in Canada, your provincial health insurance plan or the group sponsoring the study will cover the cost of care, medicine and testing. But it’s a good idea to ask the clinical trial team about possible extra costs or expenses and whether these are covered. These might include the cost of getting to the treatment centre or medicine to treat side effects of treatment, such as anti-nausea drugs 

When the trial is finished 

Some clinical trials go on for many years. While your part in the trial may be done, all participants have to finish treatment and follow-up before any results can be analyzed. This could take a while because not everyone started at the same time. When the trial is over, it takes time for the researchers to look carefully at all the results before making any conclusions.