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Glossary of Terms

Adverse reaction: An unwanted effect caused by the administration of drugs. Onset may be sudden or develop over time. Also known as adverse event or side effect.

Approved drugs: In the US, the Food and Drug Administration (FDA) must approve a substance as a drug before it can be marketed. The approval process involves several steps including pre-clinical laboratory and animal studies, clinical trials for safety and efficacy, filing of a New Drug Application by the manufacturer of the drug, FDA review of the application, and FDA approval of application.

Arm: Any of the treatment groups in a randomized trial. Most randomized trials have two "arms," but some have three "arms," or even more.

Atopic dermatitis: A form of eczema, is a chronic, inflammatory disease of the skin. The hallmark of the disease is pruritus (itchiness).

Baseline: 1. Information gathered at the beginning of a study from which variations found in the study are measured. 2. A known value or quantity with which an unknown is compared when measured or assessed. 3. The initial time point in a clinical trial, just before a participant starts to receive the experimental treatment which is being tested. At this reference point, measurable values such as CD4 count are recorded. Safety and efficacy of a drug are often determined by monitoring changes from the baseline values.

Bias: When a point of view prevents impartial judgment on issues relating to the subject of that point of view. In clinical studies, bias is controlled by blinding and randomization (See Blind and Randomization ).

Blind:A randomized trial in which the participants are not informed which arm of the trial they are on or whether they are in the experimental or control arm of the study; also called masked.

Catalysis – a modification and increase in the rate of a chemical reaction induced by material unchanged chemically at the end of the reaction

Clinical: Pertaining to or founded on observation and treatment of participants, as distinguished from theoretical or basic science.

Contraindication: A specific circumstance when the use of certain treatments could be harmful.

Control: A control is the nature of the intervention control.

Control group: The standard by which experimental observations are evaluated. In many clinical trials, one group of patients will be given an experimental drug or treatment, while the control group is given either a standard treatment for the illness or a placebo.

Controlled trials:The standard against which experimental observations may be evaluated. In clinical trials, one group of participants is given an experimental drug, while another group (i.e., the control group) is given either a standard treatment for the disease or a placebo.

Dose-ranging study: A clinical trial in which two or more doses of an agent (such as a drug) are tested against each other to determine which dose works best and is least harmful.

Double-blind study: A clinical trial design in which neither the participating individuals nor the study staff knows which participants are receiving the experimental drug and which are receiving a placebo (or another therapy). Double-blind trials are thought to produce objective results, since the expectations of the doctor and the participant about the experimental drug do not affect the outcome; also called double-masked study.

Drug-drug interaction: A modification of the effect of a drug when administered with another drug. The effect may be an increase or a decrease in the action of either substance, or it may be an adverse effect that is not normally associated with either drug.

Efficacy: (Of a drug or treatment). The maximum ability of a drug or treatment to produce a result regardless of dosage. A drug passes efficacy trials if it is effective at the dose tested and against the illness for which it is prescribed. In the procedure mandated by the FDA, Phase 2 clinical trials gauge efficacy, and Phase 3 trials confirm [the drug's effectiveness].

Eligibility criteria: Summary criteria for participant selection; includes inclusion and exclusion criteria.

Endpoint: Overall outcome that the protocol is designed to evaluate. Common endpoints are severe toxicity, disease progression, or death.

Experimental drug: A drug that is not FDA licensed for use in humans, or as a treatment for a particular condition.

Food and Drug Administration (FDA):The US Department of Health and Human Services agency responsible for ensuring the safety and effectiveness of all drugs, biologics, vaccines, and medical devices, including those used in the diagnosis, treatment, and prevention of HIV infection, AIDS, and AIDS-related opportunistic infections. The FDA also works with the blood banking industry to safeguard the nation's blood supply. Internet address: http://www.fda.gov.

Institutional Review Board (IRB): 1. A committee of physicians, statisticians, researchers, community advocates, and others that ensures that a clinical trial is ethical and that the rights of study participants are protected. All clinical trials in the US must be approved by an IRB before they begin. 2. Every institution that conducts or supports biomedical or behavioral research involving human participants must, by federal regulation, have an IRB that initially approves and periodically reviews the research in order to protect the rights of human participants.

Intent to treat: Analysis of clinical trial results that includes all data from participants in the groups to which they were randomized ( See Randomization ) even if they never received the treatment.

Investigational new drug: A new drug, antibiotic drug, or biological drug that is used in a clinical investigation. It also includes a biological product used in vitro  for diagnostic purposes.

Nanotechnology: The application of nanoscale science, engineering and technology on matter at the atomic, molecular, and supramolecular levels. This correlates to length scales roughly 1 to 100 nanometers.

Nanoscience: The study of the unique properties of matter that occur at extremely small scales.

Nanoscale: Lengths of roughly 1 to 100 nanometers or one billionth of a meter.

New drug application (NDA): An application submitted by the manufacturer of a drug to the FDA - after clinical trials have been completed - for a license to market the drug for a specified indication.

Open-label trial: A clinical trial in which doctors and participants know which drug or vaccine is being administered. Quantum mechanics: is the study of matter and radiation at an atomic level

Phase 1 trials: A study to assess a drug's safety, tested on a small sample of individuals (20-80), for the first evaluation of the drug in a human. These initial studies will determine a safe dosage range and identify side effects.

Phase 2 trials: A study to evaluate the effectiveness of the drug at various dosages for a particular indication or indications in patients with the disease, or condition under study, and to determine the common short-term side effects and risks. In many Phase 2 trials, one or more groups will receive the experimental drug and another group will be a “control” and receive a placebo or standard of care.

Phase 3 trials: A study to confirm the drug's effectiveness, monitor side effects, compare with standard of care, and record information that will allow the drug or treatments to be used safely.

Phase 4 trials: Post-marketing studies after the drug receives FDA approval, which can be conducted to provide additional information e.g., the drug's risks, benefits and optimal use.

Placebo: A placebo is an inactive substance presented in the same form, i.e., pill, cream, liquid, powder, as the experimental drug. In clinical trials, experimental treatments are often compared with placebo treatments to assess the treatment's effectiveness. In some studies, the participants in the control group will receive a placebo instead of an active drug or treatment.

Placebo controlled trial: A method of investigation of drugs in which an inactive substance (the placebo) is given to one group of participants, while the drug being tested is given to another group. The results obtained in the two groups are then compared to see if the investigational treatment is more effective in treating the condition.

Placebo effect: A physical or emotional change, occurring after a substance is taken or administered, that is not the result of any special property of the substance. The change may be beneficial, reflecting the expectations of the participant and, often, the expectations of the person giving the substance.

Plasma - a collection of charged particles (as in the atmospheres of stars or in a metal) containing about equal numbers of positive ions and electrons and exhibiting some properties of a gas but differing from a gas in being a good conductor of electricity and in being affected by a magnetic field, also referred to as the fourth state of matter

Preclinical trials: the testing that occurs before trials in humans may be carried out.

Quantum mechanics: The study of matter and radiation at an atomic level.

Randomization: A method based on chance by which study participants are assigned to a treatment group.Randomization minimizes the differences among groups by equally distributing people with particular characteristics among all the trial arms. The researchers do not know which treatment is better. From what is known at the time, any one of the treatments chosen could be of benefit to the participant.

Randomized trial: A study in which participants are randomly (i.e., by chance) assigned to one of two or more treatment arms of a clinical trial. Occasionally placebos are utilized.

Scientific rationale: A supposition or assumption advanced as a scientific basis for reasoning or argument, or as a guide to experimental investigation.

Side effects: Any undesired actions or effects of a drug or treatment. Negative or adverse effects may include headache, nausea, hair loss, skin irritation, or other physical problems. Experimental drugs must be evaluated for both immediate and long-term side effects.

Standards of care: Treatment regimen or medical management based on state-of-the-art participant care.

Statistical significance: The probability that an event or difference occurred by chance alone. In clinical trials, the level of statistical significance depends on the number of participants studied and the observations made, as well as the magnitude of differences observed.

Study endpoint: A primary or secondary outcome used to judge the effectiveness of a treatment.