Glossary A-F

Acute symptoms
Symptoms that begin quickly or only last a short period of time. A sneeze or sore throat would be acute symptoms.
Taking your medication at the right time and the right dose for the recommended period of time.
Adverse Drug Reaction (ADR)
An unintended response to a drug taken at normal doses.
Adverse Event (AE)
An adverse event is a specific undesirable medical occurrence.
  1. a new undesirable medical problem, or,
  2. worsening of a medical problem that you already have.

Undesirable medical problems might include symptoms (e.g., headache), signs (e.g., enlarged liver) or abnormal laboratory tests. An adverse event may or may not be related to your treatment.

An arm is a treatment group in a drug trial. Many drug trials have at least two arms; some have three or more arms. The arms are used to compare different treatments.
Chronic symptoms
Symptoms that last a long time or are usually present.
A group of individuals with characteristics in common. For example, a cohort might include women over 65 who have had a broken hip.
Compassionate Use
Compassionate use is when experimental treatment, not yet approved by the regulatory authorities, is given to someone who is very sick and does not have another treatment option. Compassionate use treatment is limited and special approvals are required.
A contraindication is a specific circumstance when the use of certain drugs or therapies could be harmful.
Control/Control Group
A control is the standard against which treatments are compared. A control group includes all of the subjects in an arm of a study who receive placebo (no treatment) or standard (usual) treatment.
Data Safety and Monitoring Board (DSMB)
An independent committee that reviews data while a clinical trial is in progress. They ensure that subjects are not exposed to undue risk. The committee may recommend that a trial be stopped if the trial objectives have been achieved or if there are safety concerns. The committee includes community representatives and clinical research experts.
Dose-Ranging Study
A dose-ranging study is a clinical trial to test two or more doses of the same drug to determine which dose works best and is least harmful.
In a double-blind study, neither the investigator nor the subject knows which drug or placebo the subject received.
Drug-Drug Interaction
Drug-drug interaction describes what happens sometimes when two drugs are taken at the same time. Taken together, the effect they have can change:
  • There can be an increase or a decrease in the effect of one or both drugs.
  • There may also be an adverse effect that is not normally associated with either drug.
Countries, regions or communities where an infection or disease is present.
The ability of a drug or treatment to produce a favorable result.
Based on experimental data or observations, not on a theory.
The outcome that the study is designed to evaluate.
The branch of medical science that studies the incidence, distribution and control of a disease in different populations.
Expanded Access
Expanded access is when experimental drugs are provided to patients who may benefit from the experimental therapy and are not eligible to participate in other ongoing clinical trials.
Health Outcomes
Health Outcomes measures the impact (what happens) to an individual who has received a certain treatment (could be an experimental drug, diet, exercise, etc.) Health Outcomes can include a wide range of measures, such as medical tests, frequency of doctor's visits, frequency of emergency room visits, patient satisfaction, patient preferences, and health related quality of life.
Immune system
Your body's defense system against infection and certain diseases.
In Vitro Testing
Laboratory testing that does not involve animals or humans.
In Vivo Testing
Testing in animal and humans.
The number of new cases of infection or disease occurring in a specific population in a given time period.
Inclusion and Exclusion Criteria
The rules that determine whether or not someone is eligible to enter a clinical trial. These rules are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.
Informed Consent
Informed consent means deciding if you want to take part in a study. This decision is only made after:
  1. A study staff person has explained the study
  2. You understand the purpose of the study, and
  3. You really understand what you will have to do while in the study.

A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal Investigator.

Investigators are listed on the GSK CSR only for those study sites that proceed to enrol research subjects in to the study protocol. Investigators are not listed if the site does not enrol subjects – for example if the overall study completes before the individual site is able to begin recruitment.

Morbidity Rate
The rate of illness in a population, i.e. the number of people ill during a time peirod divided by the number of people in the total population.
Mortality Rate
The rate of death in a population, i.e. the number of people who die during a time period divided by the number of people in the total population (or the number of people exposed).
Off-Label Use
An approved drug prescribed for conditions other than those approved by the regulatory authorities.
Open-Label Study
A study in which everyone is informed of the drug and dose being administered.
Orphan Drug
A regulatory agency category that refers to medications used to treat diseases and conditions that occur rarely.
The study of costs and benefits of drugs, both financial and quality of life.
The study of how different groups of people respond to drugs, based on their genetic makeup.
The study of how drugs are used and changed in the body; for example, absorption, distribution, metabolism, and excretion of a drug or vaccine.
Phase I
Phase I studies are the first studies of an experimental drug. They are usually conducted in healthy human volunteers. These studies collect information on the tolerability, pharmacokinetics and side effects of the drugs. They do not treat disease or illness.
Phase II
Phase II studies evaluate the safety and effectiveness of an experimental drug. These studies are conducted in patients with a specific disease or medical condition.
Phase III
Phase III studies compare the safety and efficacy of a new experimental treatment against existing therapies. These studies are conducted in a large number of patients with a specific disease or condition.
Phase IV
Phase IV studies are performed after regulatory authorities approval of the drug. These studies are conducted to further understand the safety of the drug in groups of patients with a specific disease or condition. They are also used to secure approval for new indications.
A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebos. When a placebo is used, neither the patient nor the doctor knows what treatment the patient is receiving.
Preclinical Phase
Laboratory or animal studies conducted prior to use of the experimental drug in people.
The total number of people infected or having a disease in a specific population at a particular time.
Principal Investigator
see Investigator
Quality of Life Trials
Studies that explore ways to improve the comfort and quality of life for people with chronic illness. For example, quality of life studies can measure the ability to perform normal daily routines, such as walking and climbing stairs.
Randomization is how people are assigned to a treatment arm in a study. The treatment the subject receives is determined by chance, not by the subject, the doctor, or anyone else.
A combination of medicines used to treat a medical condition.
Risk-Benefit Ratio
This ratio compares the potential risks of treatment to the potential benefits for an individual.
Sensitivity assesses the likelihood that a test will be positive when the person actually has the infection or disease.
Serious Adverse Event(SAE)
A Serious Adverse Event (SAE) is one type of adverse event defined by the regulatory authorities. SAEs include any event that:
  • results in death;
  • is immediately life-threatening;
  • requires in-patient hospitalization or prolongation of existing hospitalization;
  • results in persistent or significant disability or incapacity;
  • is a congential abnormality or birth defect;
  • is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above
Side Effects
A side effect is a specific unintended medical occurrence that is likely to be caused by the treatment. It can be either:
  • a new medical problem, or,
  • worsening of a medical problem that you already have.

Medical problems might include symptoms (e.g., weight loss), signs (e.g., enlarged liver) or abnormal laboratory tests.

Single-Blind Study
A study where either the investigator or the subject (not both) is aware of what drug the subject is taking.
Specificity Specificity
assesses the likelihood that a test will be negative when the person does not actually have the infection or disease.
Standard Treatment
A treatment currently in wide use and approved by the regulatory authorities for a specific disease. The standard is the usual treatment provided for the particular disease.
Study Endpoint
The outcome that the study is designed to evaluate.
A washout is a period of time with no drug. Typically, it is the period of time between the last dose of one drug and the first dose of a new drug.