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Glossary

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

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.

Regimen

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

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.

Washout

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.