The medicinal ingredient in a drug that is responsible for the therapeutic actions of the drug.
In the context of clinical trials, usually defined as individuals 18 years of age and older.
Usually defined as individuals 12 years old and less than 18 years old.
Any untoward medical occurrence in a patient or clinical investigation subject administered a drug and which does not necessarily have to have a causal relationship with the drug.
In the context of clinical trials, usually defined as a child 2 to 11 years of age.
An investigation in respect of a drug for use in humans that involves human subjects and that is intended to discover or verify the clinical, pharmacological or pharmacodynamic effects of the drug, identify any adverse events in respect of the drug, study the absorption, distribution, metabolism and excretion of the drug, or ascertain the safety or efficacy of the drug.
A unique six-digit identification number Health Canada assigns to each clinical trial application received.
A trial that includes a control group of subjects that receive a placebo treatment, no treatment, or a drug with an established therapeutic benefit (referred to as 'active control'). The results obtained in the control group are used for comparison to results obtained in the group that received the drug under investigation.
A trial in which subjects receive a sequence of different treatments.
Proteins that are produced by cells. Cytokines interact with cells of the immune system in order to regulate the body's response to disease and infection. Cytokines also mediate normal cellular processes in the body.
The date when Health Canada issued a No Objection Letter to the trial sponsor, which signifies that Health Canada considers the clinical trial acceptable. However, this does not indicate that the trial has started. It is important to note that before a clinical trial can start, it must also be approved by a research ethics board.
A trial where both the investigators and the trial subjects don't know which treatment is given.
A phase I trial in which the dose of a drug is periodically increased or decreased as new subjects are added.
The disease or a description of the intended indication that is being investigated in the clinical trial.
An antibody produced by a single clone of cells. A monoclonal antibody is a single pure type of antibody.
A trial that is conducted in more than one country.
Born children under the age of 28 days.
A woman that is breastfeeding.
A virus that preferentially infects and kills cancer cells.
A trial in which both trial subjects and trial investigators know which treatment is actually given.
Administration by mouth.
A drug developed for a rare condition/ disease (a disease that affects usually less than 5 individuals per 10 000).
Indicates that two or more treatments are evaluated in parallel, meaning at the same time, in two or more separate groups of patients that are also named treatment groups / arms.
Any administration that is not through the gastrointestinal system, meaning oral and rectal. For example, intra-venous, intra-muscular, sub-cutaneous administrations are parenteral administrations.
Individuals who have a medical condition.
Population that may include pre-term newborns, newborns, children or adolescents.
Mechanism by which the drug acts on the body.
Study of how genetic factors affect the response to drugs.
Study of the level of a drug in various tissues of the body, for example, blood.
Phase I clinical trial
Clinical trials designed mainly to determine the pharmacological actions of the drug and the safety (side effects) associated with increasing doses. Pharmacokinetic studies (evaluating drug levels in tissues such as blood) as well as drug interaction studies are usually considered as Phase I trials regardless of when they are conducted during drug development. Phase I trials are generally conducted in healthy volunteers, but may be conducted in patients when administration of the drug to healthy volunteers is not ethical.
Phase II clinical trial
Clinical trials to evaluate the efficacy of the drug in patients with medical conditions to be treated, diagnosed or prevented and to determine the side effects and risks associated with the drug. If a new indication for a marketed drug is to be investigated, then those clinical trials may generally be considered Phase II trials. These trials provide preliminary information on the safety and efficacy of the drug in patients.
Phase III clinical trial
Controlled or uncontrolled trials conducted after preliminary evidence suggesting efficacy of the drug has been demonstrated. These are intended to gather the additional and confirmatory information about the clinical efficacy and safety under the proposed conditions of use for the drug.
Phase IV clinical trial
All studies performed within the approved indication after the drug has been approved by the regulator for the market. These studies are often important for optimizing the drug's use. They may be of any type but must have valid scientific objectives. Commonly conducted studies include safety studies and studies designed to support use under the approved indication, for example mortality and morbidity studies, or epidemiological studies. These trials do not usually require regulatory approval by Health Canada.
A control treatment that does not contain the medicinal ingredient that is given to a group of trial subjects.
Per orem or per os, which means by mouth.
Preterm newborn infant
Usually designates an infant born before 37 weeks of its conception.
Previously Treated Patient (PTP)
Patients who have been previously treated for a disease
Previously Untreated Patients (PUP)
Patients who have not been previously treated for a disease.
A procedure/ measure used to prevent the development of a disease or to prevent the recurrence of the disease.
A document that describes the objective(s), design, methodology, statistical considerations and organisation of a trial.
A concise, summarised description used by sponsors to briefly characterise the protocol.
A radioactive drug. These can be used to treat or diagnose a medical condition.
A trial in which trial subjects are allocated to a given treatment by chance.
Recombinant medicinal product
A drug elaborated using genetic material from various organisms.
A trial that gathers information on the adverse effects of a drug. Usually all clinical trials of drugs in development will collect information on adverse events.
Indicates that trial subjects don't know the treatment they are taking [for example (e.g.), placebo Vs test drug) but the investigator of the trial does.
Somatic cell therapy
Means the use of autologous (emanating from the patient himself), allogeneic (coming from another human being) or xenogeneic (coming from animals) somatic living cells (cells not involve in reproduction such as ovules and spermatozoa) for therapeutic, diagnostic or preventive effect.
A "PENDING" status means Health Canada is pending the receipt of information from the sponsor indicating that the trial started. An "ONGOING" status means Health Canada has received information from the sponsor indicating the proposed study start date, and an "ENDED" status means Health Canada has received information from the sponsor indicating that the clinical trial has ended.
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