INDEPTH: DRUGS
Clinical trials
Glossary of drug trial terminology
CBC News Online | March 15, 2006
Adverse Drug Reaction (ADR)
An unintended reaction to a drug taken at doses normally used in humans for prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function. In clinical trials, an ADR would include any injuries by overdosing, abuse/dependence, and unintended interactions with other medicinal products.
Adverse Event (AE)
A negative experience encountered by an individual during the course of a clinical trial, that is associated with the drug. An AE can include previously undetected symptoms, or the exacerbation of a pre-existing condition. When an AE has been determined to be related to the product on trial, it is considered an Adverse Drug Reaction.
Adverse Event Reports
Investigator reports of all serious and adverse events, injury and deaths given to the sponsor, the REB and Health Canada.
Biologic
A virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product applicable to the prevention, treatment or cure of diseases or injuries of humans.
Biotechnology
Any technique that uses living organisms, or substances from organisms, biological systems, or processes to make or modify a product or process, to change plants or animals, or to develop micro-organisms for specific uses.
Blinding
The process through which one or more parties to a clinical trial are unaware of the treatment assignments. In a single-blinded study, usually the subjects are unaware of the treatment assignments. In a double-blinded study, both the subjects and the investigators are unaware of the treatment assignments. Also, in a double-blinded study, the monitors and sometimes the data analysts are unaware. "Blinded" studies are conducted to prevent the unintentional biases that can affect subject data when treatment assignments are known.
Clinical Investigation
A systematic study designed to evaluate a product (drug, device, or biologic) using human subjects, in the treatment, prevention, or diagnosis of a disease or condition, as determined by the product's benefits relative to its risks. Clinical investigations can only be conducted with the approval of Health Canada.
Clinical Research
Study of drug, biologic or device in human subjects with the intent to discover potential beneficial effects and/or determine its safety and efficacy. Also called clinical study and clinical investigation. It does not encompass all the research that is carried out in the clinical setting (e.g., health services research).
Clinical Study Materials
Study supplies (i.e., study test article, laboratory supplies, case report forms) provided by the study sponsor to the investigator.
Clinical Trial
Any investigation in human subjects intended to determine the clinical pharmacological, pharmacokinetic, and/or other pharmacodynamic effects of an investigational agent, and/or to identify any adverse reactions to an investigational agent to assess the agent's safety and efficacy.
Consent Form
A document explaining all relevant study information to assist the study volunteer in understanding the expectations and requirements of participation in a clinical trial. This document is presented to and signed by the study subject.
Contract Research Organization (CRO)
A person or an organization (commercial, academic or other) contracted by the sponsor to perform one or more of a sponsor's study-related duties and functions.
Control Group
A comparison group of study subjects who are not treated with the investigational agent. The subjects in this group may receive no therapy, a different therapy, or a placebo.
Data
This term is legally defined according to the institution. It generally refers to recorded information regardless of form. Most institutions hold title to data while researchers have rights to access the data.
Data Management
The process of handling the data gathered during a clinical trial. May also refer to the department responsible for managing data entry and database generation and/or maintenance.
Deception
Intentionally misleading or withholding information about the nature of an experiment.
Declaration of Helsinki
A series of guidelines adopted by the 18th World Medical Assembly in Helsinki, Finland, in 1964. The declaration addresses ethical issues for physicians conducting biomedical research involving human subjects. Recommendations include the procedures required to ensure subject safety in clinical trials, including informed consent and ethics committee reviews.
Demographic Data
Refers to the characteristics of study participants, including sex, age, family medical history, and other characteristics relevant to the study in which they are enrolled.
Device
An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part or accessory, which is intended for use in the diagnosis, cure, treatment or prevention of disease. A device does not achieve its intended purpose through chemical action in the body and is not dependent upon being metabolized to achieve its purpose.
Documentation
All forms of records that describe or document study methods, conduct and results, including any adverse events and actions taken.
Double blind
The design of a study in which neither the investigator or the subject knows which medication (or placebo) the subject is receiving.
Drug
As defined by the Food and Drugs Act, a drug "includes any substance or mixture of substances manufactured, sold or represented for use in a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals, b) restoring, correcting or modifying organic functions in human beings or animals, or c) disinfection in premises in which food is manufactured, prepared or kept."
Drug product
A finished dosage form (e.g. tablet, capsule, or solution) that contains the active drug ingredient usually combined with inactive ingredients.
Effective dose
The dose of an investigational agent that produces the outcome considered "effective," as defined in the study protocol. This could mean a cure of the disease in question or simply the mitigation of symptoms.
Efficacy
A product's ability to produce beneficial effects on the duration or course of a disease. Efficacy is measured by evaluating the clinical and statistical results of clinical tests.
Ethics committee
An independent group of both medical and non-medical professionals who are responsible for verifying the integrity of a study and ensuring the safety, integrity, and human rights of the study participants.
Exclusion criteria
Refers to the characteristics that would prevent a subject from participating in a clinical trial, as outlined in the study protocol.
Food and Drug Administration (FDA)
The U.S. Department of Health and Human Services agency that enforces the U.S. Food, Drug and Cosmetics Act and related federal public health laws, and grants investigational and new drug approvals.
Formulation
The mixture of chemicals and/or biological substances and excipients used to prepare dosage forms.
Generic drug
A medicinal product with the same active ingredient, but not necessarily the same inactive ingredients as a brand-name drug. A generic drug may only be marketed after the original drug's patent has expired.
Good clinical practice (GCP)
International ethical and scientific quality standard for designing, conducting, monitoring, recording, auditing, analyzing and reporting studies. Insures that the data reported is credible and accurate, and that the subject's rights and confidentiality are protected.
Human subject
A patient or healthy individual participating in a research study. A living individual about whom an investigator obtains private information or data through intervention or interaction.
Inclusion criteria
A list of criteria that must be met by all study subjects.
Informed consent
The voluntary verification of a patient's willingness to participate in a clinical trial, along with the documentation thereof. This verification is requested only after complete, objective information has been given about the trial, including an explanation of the study's objectives, potential benefits, risks and inconveniences, alternative therapies available, and of the subject's rights and responsibilities in accordance with the current revision of the Declaration of Helsinki.
Institution
Location of research. Retains ultimate responsibility for human subject regulation compliance.
Investigator
A medical professional, usually a physician but may also be a nurse, pharmacist or other health-care professional, under whose direction an investigational drug is administered or dispensed. A principal investigator is responsible for the overall conduct of the clinical trial at his/her site.
Investigator's brochure
Relevant clinical and non-clinical data compiled on the investigational drug, biologic or device being studied.
In vitro testing
Non-clinical testing conducted in an artificial environment such as a test tube or culture medium.
In vivo testing
Testing conducted in living animal and human systems.
Longitudinal study
A study conducted over a long period of time.
Monitor
Person employed by the sponsor or CRO who reviews study records to determine that a study is being conducted in accordance with the protocol. A monitor's duties may include, but are not limited to, helping to plan and initiate a study, and assessing the conduct of studies. Monitors work with the clinical research co-ordinator to check all data and documentation from the study. See also CRA.
Monitoring
Reviewing a clinical study, ensuring conduct, proper records and reports are performed as stated in the clinical protocol, standard operating procedures, GCP and by regulatory requirements.
Nuremberg code
As a result of the medical experimentation conducted by Nazis during the Second World War, the U.S. Military Tribunal in Nuremberg in 1947 set forth a code of medical ethics for researchers conducting clinical trials. The code is designed to protect the safety and integrity of study participants.
Off label
The use of a drug for a purpose other than that approved of by Health Canada.
Open-label study
A study in which all parties, (patient, physician and study coordinator) are informed of the drug and dose being administered. In an open-label study, none of the participants are given placebos. These are usually conducted with Phase I & II studies.
Over the counter (OTC)
Drugs available for purchase without a physician's prescription.
Patient
Individual seeking medical care.
Pharmacoeconomics
The study of cost-benefit ratios of drugs with other therapies or with similar drugs. Pharmacoeconomic studies compare various treatment options in terms of their cost, both financial and quality of life. Also referred to as "outcomes research."
Phase I study
The first of four phases of clinical trials, Phase I studies are designed to establish the effects of a new drug in humans. These studies are usually conducted on small populations of healthy humans to specifically determine a drug's toxicity, absorption, distribution and metabolism.
Phase II study
After the successful completion of phase I trials, a drug is then tested for safety and efficacy in a slightly larger population of individuals who are afflicted with the disease or condition for which the drug was developed.
Phase III study
The third and last pre-approval round of testing of a drug is conducted on large populations of afflicted patients. Phase III studies usually test the new drug in comparison with the standard therapy currently being used for the disease in question. The results of these trials usually provide the information that is included in the package insert and labeling.
Phase IV study
After a drug has been approved by Health Canada, phase IV studies are conducted to compare the drug to a competitor, explore additional patient populations, or to further study any adverse events.
Pivotal study
Usually a phase III study which presents the data that Health Canada uses to decide whether or not to approve a drug. A pivotal study will generally be well-controlled, randomized, of adequate size, and whenever possible, double blind.
Placebo
An inactive substance designed to resemble the drug being tested. It is used as a control to rule out any psychological effects testing may present. Most well-designed studies include a control group which is unwittingly taking a placebo.
Pre-clinical testing
Before a drug may be tested on humans, pre-clinical studies must be conducted either in vitro but usually in vivo on animals to determine that the drug is safe.
Protocol
A detailed plan that sets forth the objectives, study design, and methodology for a clinical trial. A study protocol must be approved by an REB before investigational drugs may be administered to humans.
Protocol amendment
Changes or clarifications made in writing to the original protocol.
Quality assurance
Systems and procedures designed to ensure that a study is being performed in compliance with Good Clinical Practice (GCP) guidelines and that the data being generated is accurate.
Randomization
Study participants are usually assigned to groups in such a way that each participant has an equal chance of being assigned to each treatment (or control) group. Since randomization ensures that no specific criteria are used to assign any patients to a particular group, all the groups will be equally comparable.
Recruitment
Act of enrolling subjects with the proper inclusion criteria.
Recruitment period
Time allowed to recruit all subjects for a study.
Regulatory affairs
In clinical trials, the department or function that is responsible for ensuring compliance with government regulations and interacts with the regulatory agencies. Each drug sponsor has a regulatory affairs department that manages the entire drug approval process.
Research
Systematic investigation designed to develop or contribute to generalizable knowledge. Includes Clinical Research.
Review Ethics Board (REB)
An independent group of professionals designated to review and approve the clinical protocol, informed consent forms, study advertisements, and patient brochures, to ensure that the study is safe and effective for human participation. It is also the REB's responsibility to ensure that the study adheres to Health Canada's regulations.
Research team
Investigator, sub-investigator and clinical research co-ordinator involved with study.
Risk benefit ratio
Risk to individual subject vs. potential benefits. Also called Risk-Benefit Analysis.
Serious adverse event (SAE)
Any adverse event (AE) that is fatal, life-threatening, permanently disabling, or which results in hospitalization, initial or prolonged.
Source data
All information contained in original records and certified copies of results, observations or other facets required for the reconstruction and evaluation of the study that is contained in source documents.
Source documentation
Location where information is first recorded including original documents, data and records.
Sponsor
Individual, company, institution or organization taking responsibility for initiation, management and financing of study.
Standard operating procedure (SOP)
Official, detailed, written instructions for the management of clinical trials. SOPs ensure that all the functions and activities of a clinical trial are carried out in a consistent and efficient manner.
Standard treatment
The currently accepted treatment or intervention considered to be effective in the treatment of a specific disease or condition.
Sub-investigator
Helps design and conduct investigation at a study site.
Subject/study subject
Participant in a study. See "Human Subject."
Telephone report
Notification via telephone to Health Canada of unexpected fatal or life threatening advent associated with a clinical study.
Unexpected adverse drug reaction
A reaction that is not consistent in nature or severity with study application.
Vulnerable subjects
Group/individual that cannot give informed consent because of limited autonomy (e.g., children, mentally ill and prisoners). Also refers to subjects who may be unduly influenced to participate (e.g., students, subordinates and patients).
Well being
Subject's physical and mental soundness.
^TOP
|
|
 |
 MENU |
|
|
| QUICK FACT |
In Canada, a clinical research nurse/clinical research associate with two to four years experience can expect to make between $25,000 and $32,900 US. A comparable nurse in a U.S. hospital or clinical site stands to earn $50,000 - $60,000 US.
(Source: Industry Canada)
|
|
| EXTERNAL LINKS: |
|
|
| MORE: |
|
|
|
CBC does not endorse and is not responsible for the content of external sites. Links will open in new window.
