Clinical Trials

GLOSSARY OF CLINICAL TRIAL TERMS The following terms are sourced from Clinical Trials Ontario. For a more extensive glossary of terms, including different treatment types, see the Save Your Skin glossary of melanoma terms. Adverse Event (also called reaction/side effect) An unintended medical event that may happen during a clinical trial and that may or may not be expected and may or may not be due to the intervention(s) being tested. Adverse events can be mild or less serious (for example a rash) or more severe or serious (for example, death). All adverse events that happen during a trial are reported whether or not they are caused by the intervention. For some people, considering potential adverse events is important when they are thinking about participating in a clinical trial. Arm A group of participants in a clinical trial that receive a specific intervention (or no intervention) based on the protocol of the clinical trials. Bias In a clinical trial, this is a flaw in the study design or in how information is collected or interpreted. A bias may lead to incorrect conclusions being drawn from the study. Blinded If a trial is “blinded” one or more individuals do not know what treatment group participants are randomized to. When participants are “blinded” they do not know which intervention they are receiving. A “double-blinded” study is when both the participants and the study team do not know which treatment arm the participants are in. Blinding is used to help ensure the assessment of outcomes (e.g., disease status, side effects) of a trial are not biased by people knowing what treatment participants receive. Efficacy Another word for effectiveness, which means the ability of an intervention to produce a desired effect or do what it is supposed to do. Eligibility Criteria The ‘qualifications’ set that determines whether or not the trial is right for you. These qualifications may include a disease or condition, a certain age range, living in or near a specific location, a specific ethnicity, etc. Inclusion criteria are the characteristics needed to be part of the clinical trial. For example, for a cancer clinical trial, this might be specific genetic characteristics. Exclusion criteria are characteristics that don’t allow participation in the clinical trial, for example, ‘pregnancy’ or a specific health condition. Endpoint A result that is measured and is used to see whether the clinical trial intervention is beneficial or not. Some examples may include whether a participant contracted a disease, how long a participant survived after receiving a treatment, etc. Expanded Access Sometimes also called compassionate use. This is a way for patients to access interventions that are not yet approved by a regulatory agency, and in circumstances where there are not comparable or satisfactory treatments options available outside of a clinical trial. Informed Consent Participation in a clinical trial is voluntary. If you are thinking about participating in a clinical trial it is important that you are provided with enough information to make an informed decision, an opportunity to ask questions and talk to others you may choose to (e.g. your family or friends) and the time to make a decision that is right for you. A key part of the informed consent process for most clinical trials is a document called the ‘informed consent form’ or ‘consent form’. This document should provide all relevant information about the clinical trial and be written in a way that is understandable to you. You should be given enough time to read it and ask any questions you may have. If you agree to participate, you may be asked to sign the consent form and should be provided with a copy of the form for your own keeping. Informed consent does not always need to be provided in a written consent form. It may be provided in another, non-written form, and however this happens, it is always approved by a Research Ethics Board. Informed consent is an ongoing process throughout a clinical trial. You can withdraw your consent to participate at any time. If you are in a clinical trial and your doctor or study team learn new information that might affect your willingness to continue to participate (e.g., new safety information about the intervention), you should be provided with this information. Intervention Clinical trials study different treatments or interventions on their own or in combination with others. Different intervention types studied in clinical trials may include: • a drug such as a pill, an intravenous treatment, etc. • a medical device such as a pacemaker or an insulin pump • a type of surgery • radiation therapy • a diagnostic procedure • a diet and lifestyle change such as exercise. Masking Another word for blinding Open Label Extension An extension to a blinded placebo-controlled clinical trial whereby all participants receive the active study drug or treatment, no matter which study treatment arm they started in. When the extension trial starts, participants and the study team are considered ‘unblinded’ since they know all participants are receiving the active study drug or treatment (vs. the placebo). Outcome A characteristic(s) being measured in a clinical trial that is related to health. Some examples may include disease status (e.g., if the disease being studied gets worse or better), survival status (how long participants live), health status (fatigue or pain) and side effects. Placebo A clinical trial protocol contains detailed documents with information on how and why the trial is being done, how the trial will be done, how the results will be gathered, analyzed and shared, and who is involved. The typical parts of a clinical trial protocol are: • Background scientific and clinical information • Justification on why the trial is important • Key measurements or endpoints of the trial Who can and can’t be in the clinical trial also called the eligibility and ineligibility criteria What treatments will be used and how, and how or if any adjustments to treatment will be made. The assessments that will be undertaken, including what kind, when, and the type of assessment (for example, blood tests, doctors visits, questionnaires, etc.) A sample informed consent form: • The number of participants needed and why • How results will be analyzed and shared • Safety reporting information • Data that will be collected Protocol A clinical trial protocol contains detailed documents with information on how and why the trial is being done, how the trial will be done, how the results will be gathered, analyzed and shared, and who is involved. The typical parts of a clinical trial protocol are: Background scientific and clinical information Justification on why the trial is important Key measurements or endpoints of the trial Who can and can’t be in the clinical trial also called the eligibility and ineligibility criteria What treatments will be used and how, and how or if any adjustments to treatment will be made The assessments that will be undertaken, including what kind, when, and the type of assessment (for example, blood tests, doctors visits, questionnaires, etc.) A sample informed consent form: • The number of participants needed and why • How results will be analyzed and shared • Safety reporting information • Data that will be collected. Randomized Another way of saying you get there by chance. A common type of clinical trial is a “randomized” clinical trial. These are typically called “phase 3 trials”. In randomized trials two or more interventions (or treatment arms) are being compared to each other. When a trial is randomized, participants are assigned by chance to one of the interventions (or treatment arms). This is important in helping to ensure the results of the trial are not due to health professionals or participants choosing what treatment arm they want to participate on. Research Ethics Board (REB) An independent committee of people with different expertise (for example, law, medicine, ethics, community, etc.) that reviews the ethical acceptability of research involving humans. The REB reviews all study materials including protocols and information or materials given to potential or actual participants with a view to ensuring participants are properly informed and free to make a voluntary decision about participating, and that a study’s potential risks are balanced with potential benefits. The REB continues to review information about the study as long as it is ongoing, including any adverse events and changes to the study along the way. Sponsor The term sponsor is used in two ways in Canada. Health Canada considers the ‘sponsor’ of the trial the organization or individual that is responsible for the regulatory submission and overall conduct of the trial. This can be a company, a hospital, a research group or a clinician researcher. The word sponsor is also used in Canada to describe who is funding the clinical trial. This might be pharmaceutical or medical device company, for example. This same company may or may not be the regulatory sponsor with Health Canada. Withdrawal You can choose to end your participation in the clinical trial at any time without having to provide a reason – this is called withdrawal. If you choose to withdraw from the study, you are encouraged to contact the study doctor or study staff to let them know your decision or to ask them further questions before you make a decision. If you do withdraw, you may be asked questions about your experience with the intervention, and to have laboratory tests and physical examinations considered necessary to safely stop your participation. You may also be able to withdraw your permission to use information that was collected about you for the clinical trial intervention. The study doctor may stop your participation in a study early, and without your consent, for reasons such as: • The study intervention does not work for you • You are unable to tolerate the study intervention • You are unable to complete all required study procedures • New information shows that the study intervention is no longer in your best interest • The study doctor no longer feels this is the best option for you • The Sponsor decides to stop the study • The Regulatory Authority/ies (for example, Health Canada) or research ethics board withdraw permission for this study to continue Your group assignment becomes known to you or others (like the study doctor or study staff) If you are female and plan to or become pregnant If this happens, it may mean that you would not receive the study intervention for the full period described in this consent form. If you are removed from a study, the study doctor will discuss the reasons with you and plans will be made for your continued care outside of the study.