The medicinal ingredient in a drug that is responsible for the therapeutic actions of the drug.
Adults
In the context of clinical trials, usually defined as individuals 18 years of age and older.
Adolescent
Usually defined as individuals 12 years old and less than 18 years old.
Adverse event
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.
Children
In the context of clinical trials, usually defined as a child 2 to 11 years of age.
Clinical trial
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.
Controlled trial
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.
Crossover trial
A trial in which subjects receive a sequence of different treatments.
Cytokines
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.
Double-blind trial
A trial where both the investigators and the trial subjects don't know which treatment is given.
Dose-escalation trial
A phase I trial in which the dose of a drug is periodically increased or decreased as new subjects are added.
Name given to the drug used in the clinical trial. This may be a code name, the chemical name of the active ingredient, the non-proprietary name, or a brand name.
Efficacy trial
A trial designed to determine if a treatment is able to treat or prevent a given medical condition.
Elderly
Usually defined as individuals that are 65 years old or older.
First in human administration
A clinical trial where a drug is administered for the first time in humans.
Formulation (formulation of a drug)
The chemical composition of the final medicinal product which includes the active ingredient as well as other ingredients (non-medicinal ingredients).
Fusion Proteins
Proteins created through the joining of two or more genes which were originally coded for separate proteins.
Gene Therapy
A technique for the treatment of genetic disease in which a gene that is absent or defective is replaced by a healthy gene.
Healthy volunteers
Clinical trial subjects that are considered healthy.
Human pharmacology trials
Early trials that usually involve a limited group of healthy volunteers or patients. These trials are designed to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of a drug.
IM
Intra-muscular.
Immunoglobulin
A protein produced by plasma cells and lymphocytes and characteristic of these types of cells. They attach to foreign substances, such as bacteria, and assist in destroying them.
Interventional trial
A trial in which the treatment assigned to the trial subject is predefined by the trial protocol.
In Utero
Unborn, in the womb.
Investigator
Person responsible for the management of the study conduct and subjects.
In Vivo
Within the living body, as opposed to in vitro (in the laboratory).
Infants
Defined usually as children of 28 days old to less than 2 years of age.
IV
Intra-venous
IVRS
Interactive voice response system that allows a computer to interact with humans through the voice and is commonly used for randomisation of treatment.
Ligand
A molecule that binds to another. Often a soluble molecule such as a hormone or neurotransmitter, that binds to a receptor.
The disease or a description of the intended indication that is being investigated in the clinical trial.
Monoclonal Antibody
An antibody produced by a single clone of cells. A monoclonal antibody is a single pure type of antibody.
Multinational trial
A trial that is conducted in more than one country.
Newborns
Born children under the age of 28 days.
Nursing women
A woman that is breastfeeding.
Oncolytic Virus
A virus that preferentially infects and kills cancer cells.
Open trial
A trial in which both trial subjects and trial investigators know which treatment is actually given.
Oral administration
Administration by mouth.
Orphan drug
A drug developed for a rare condition/ disease (a disease that affects usually less than 5 individuals per 10 000).
Parallel groups
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.
Parenteral administration
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.
Patients
Individuals who have a medical condition.
Pediatric population
Population that may include pre-term newborns, newborns, children or adolescents.
Pharmacodynamic
Mechanism by which the drug acts on the body.
Pharmacogenetic:
Study of how genetic factors affect the response to drugs.
Pharmacokinetic
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.
Placebo
A control treatment that does not contain the medicinal ingredient that is given to a group of trial subjects.
P.O.
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.
Prophylaxis
A procedure/ measure used to prevent the development of a disease or to prevent the recurrence of the disease.
Protocol
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.
Radiopharmaceutical
A radioactive drug. These can be used to treat or diagnose a medical condition.
Randomized
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.
Safety trial
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.
Single blind
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.
Body (e.g. Pharmaceutical Companies, research group), or person (investigator) responsible for the conduct of the trial.
Stem Cells
Stem cells are different from other cells of the body in that they have the ability to differentiate into other cell/tissue types. This ability allows them to replace cells that have died.
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.
