Clinical Research

• Observational studies: Look at data to find patterns that answer research questions 

• Interventional studies: Test new treatments or improvements to existing treatments.  

Clinical trials are run in a series of steps, known as phases. Each phase is designed to answer a specific scientific question about the treatment or technique being tested. Once the treatment is successful in one phase, it will move onto the next phase for further testing. As a clinical trial participant, you would only be taking part in one phase of the new treatment. 

Phase 1 

Purpose: to determine how safe a new treatment is which may include identifying a safe dose (how much medication). This may also include determining the best way to give the new treatment (by mouth or in a vein, for example) as well as the effects the treatment may have on the body. 

Phase 2 

Purpose: to determine how well the specific treatment works (effectiveness) and further assess safety. This will also include ongoing monitoring of the effects the treatment may have on the body. 

Phase 3 

Purpose: to compare the new treatment with the current standard of treatment. Trials in this phase will also continue to closely monitor patients for effects the treatment may have on the body. 

Phase 4 

Purpose: to look at the long-term safety and effects of the treatment. Trials in this phase take place after the treatment has been approved for market (use in a hospital or clinic setting). 

Every clinical trial has guidelines about who can participate. These guidelines help to ensure that all trial participants are similar in key ways. This is so researchers can be more certain the trial results are from the treatment and not from other factors. The guidelines for each trial are written in what is known as the trial protocol. 

To find out if you qualify for a clinical trial, please speak with your doctor. Additional tests may be required to ensure that you meet all criteria for participating in a certain trial.

Deciding to take part in a clinical trial is a decision that you, those close to you, your doctor and health-care team make together. Ultimately, it is your personal choice to participate or not. By considering a clinical trial as part of your treatment, you are actively taking part in a decision that affects your life. The following are things to consider when making your decision. 

Possible risks and benefits 

As with all treatments, clinical trials have both benefits and risks. It is important to discuss possible benefits and risks with your doctor as well as with those close to you. Each patient may face different benefits and risks. 

Possible benefits may include: 

• You may be among the first to receive a new treatment that is otherwise not available 

• If the new treatment works and you are receiving it, you may or may not be among the first to benefit 

• You will be closely followed by your doctor and the research team 

• If you are placed in the group that does not receive the new treatment, you will still receive the best standard of treatment available. This may be as good as the new treatment that is being studied 

• You have the chance to help scientists learn more about a condition that will benefit future patients 

Possible risks may include: 

• If you receive the new treatment it may not be better than the current standard of treatment 

• You may experience side effects of the new treatment 

• If you are in the group that receives the standard treatment, you may not do as well as the group that receives the new treatment 

• The new treatment may work for other patients but not for you 

• You may be required to attend additional appointments, take additional medications and have additional tests 

It is important to feel that your health, safety and privacy are protected when you participate in a clinical trial. It is also important to know that you have rights when participating in a clinical trial. Some of these are outlined below. 

How you’re protected 

To protect participants, clinical trials must follow strict rules and meet high standards. These include approval and ongoing monitoring of the trial by: 

• Research Ethics Boards 

• International Conference on Harmonization Good Clinical Practice Guidelines 

• Sunnybrook Policies and Procedures 

• Regulatory Boards, such as Health Canada and the US Food and Drug Administration when appropriate 

Trial protocol 

The trial protocol is a written document that acts as the plan for the trial. It includes all of the information required for research staff to carry out the trial. It will include information about: 

• The reason why the trial is being done 

• Who can participate in the trial 

• How many people are required to participate 

• What treatments participants will receive, including doses and how often 

• What medical tests are required and how often 

• How long the trial is expected to run for 

• What information is collected about participants 

• How to manage side effects of the trial treatment 

• How the researchers will measure if the treatment is working 

Informed consent 

Before deciding to take part in a clinical trial, you will be informed by research staff of the purpose of the trial, the possible risks, possible benefits and what involvement will be required from you. The process of learning this information and making a decision based on it is called informed consent. It is an important step in clinical trials to ensure patient safety. The informed consent is specific to the trial’s protocol. The research staff will go over the document with you to explain the trial in detail, including: 

• The purpose of the trial 

• What treatments will be involved 

• Possible risks, benefits and side effects 

• What tests and procedures may be required 

• What information about you will be collected 

• How your information will be kept confidential 

• Who to contact if you have questions about the trial 

You will receive a printed copy of the informed consent form to read, review and sign if you decide to participate. You will also be able to take the form home. The form must be written in terms that you easily understand. The research staff will be there to answer any questions you may have and to ensure that you fully understand all aspects of the trial. You have the right to take your time to understand the trial and to decide if you want to participate. 

Withdrawing 

You are able to leave a trial at any time, even after signing the informed consent form. Participating in a clinical trial is voluntary and you have the right to make the decision to withdraw from the trial at any point. If you decide to leave a trial, your doctor will discuss treatment options with you and you will continue to receive the best standard treatment available.