Glossary

Adherence - How well participants follow the treatment plan in a clinical trial.

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Clinical trial - A study of medical treatments (medicines, devices or procedures).

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Clinical trial medication - The medication being tested in a clinical trial.

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Control group - The group of clinical trial participants who do not receive the new treatment. These participants receive either a placebo or standard therapy.

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Controlled clinical trial - A clinical trial that involves dividing participants into two groups, treatment and control. In this type of clinical trial, participants are randomly assigned to one of the two treatments.

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Data Monitoring Committee (DMC) - A committee that reviews data from a clinical trial to see if there is clear harm or benefit for participants while a clinical trial is still on-going. This committee has the ability to stop a clinical trial early if necessary.

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Double masked clinical trial - A clinical trial in which neither the participant nor the clinical trial doctor/nurse know whether the participant is receiving the new treatment or a standard treatment (or placebo).

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Experimental group - The group of clinical trial participants that receive the new treatment.

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Food and Drug Administration (FDA) - The government agency responsible for making sure that drugs and medical devices are safe and effective.

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Informed consent - A participant's right to know all the clinical trial's instructions and procedures, all the risks and benefits of being in the clinical trial and have all his/her questions answered before choosing whether to participate in the clinical trial. This information must be given to the participant both verbally and in writing. Before a participant can participate in a clinical trial, the participant must sign the clinical trial's informed consent form. By signing the informed consent form, the participant acknowledges that he/she understands what participation in the clinical trial will involve and has made a decision to participate. See the section "What is Informed Consent?" for a further explanation.

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Institutional Review Board (IRB) or Human Rights Committee (HRC) - A committee that is not a part of the clinical trial. This committee reviews and approves protocols to make sure that participants are not exposed to unnecessary or excessive risks.

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Medical device - A product that is made or constructed for a particular medical need or purpose (hearing aid, dental implants, intraocular lens, etc.).

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Phase I clinical trial - A clinical trial that tries to show the initial safety of a new medication. These clinical trials are usually done in healthy volunteers.

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Phase II clinical trial - A clinical trial that tries to see if the medication can work in participants with the disease to be treated.

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Phase III clinical trial - Phase IV clinical trial/Post-marketing surveillance participants with the disease to be treated.

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Phase IV clinical trial/Post-marketing surveillance - A clinical trial that is carried out after a medicationis marketed or approved for licensing by the FDA. It evaluates the medication's long-term effects.

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Placebo - A tablet or capsule that contains no medication.

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Protocol - A document that tells the clinical trial doctors how the clinical trial will be conducted.

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Randomization - The process by which a clinical trial patient is assigned to a treatment group by chance (like by the flip of a coin). Participants are randomly assigned to receive either the new treatment or a standard treatment (or placebo).

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Research and Development Committee - A committee formed at each VA facility doing medical research. This committee is responsible for the review of the design of all research projects involving humans. This committee also works closely with the Institutional Review Board at the VA facility to make sure all legal and ethical issues are reviewed.

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Side effect - Any effect caused by a medication other than what was intended when a patient takes a medicine.

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Single masked clinical trial design - A clinical trial in which the participant does not know whether he/she received the new treatment or a standard treatment (or placebo) until the end of the clinical trial. In this type of clinical trial, the doctor and nurse are aware of which treatment the patient is receiving.

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Sponsor - The person, agency, university or pharmaceutical company who pays for the clinical trial.

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Standard therapy/Standard treatment - The usual treatment for an illness to which a new treatment may be compared. This is also known as the control.

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Treatment group - The group of clinical trial participants that receive the new treatment.

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Treatment plan - The way the medication will be used in a clinical trial. The plan is described in the clinical trial's protocol.

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Uncontrolled clinical trial - A clinical trial in which clinical trial doctor and nurse and the participant know what medications are being used. This is also called an open-label clinical trial .