- 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
It can be either:
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.
For more information on this register please email GSKClinicalSupportHD@gsk.com
GSK-sponsored clinical studies are those for which GSK is ultimately responsible for all aspects of the study even if some or all of these activities are transferred to another party.
GSK-sponsored clinical trials are those for which GSK is ultimately responsible for all aspects of the study even if some or all of these activities are transferred to another party.
ClinicalTrial.gov is a database that provides summary protocol information for ongoing clinical trials.
IFPMA.org is a search portal provided by the International Federation of Pharamceutical Manufacturers & Associations (IFPMA).
This portal provides a single entry point to search for industry sponsored clinical trials which are on existing registers and databases.
EU Clinical Trials Register is a database of all clinical trials commencing in the European Community from 1 May 2004 onwards. It has been established in accordance with Directive 2001/20/EC.