The following are the terms used in clinical trials.
ADVERSE REACTION: An unwanted effect caused by the administration of drugs. Onset may be sudden or develop over time.
ADVOCACY AND SUPPORT GROUPS: Organizations and groups that actively support participants and their families with valuable resources, including self-empowerment and survival tools.
APPROVED DRUGS: In the U.S., the Food and Drug Administration (FDA) must approve a substance as a drug before it can be marketed.
ARM: Any of the treatment groups in a randomized trial. Most randomized trials have two "arms," but some have three "arms," or even more.
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 processes.
BLIND: A randomized trial is "Blind" if the participant is not told which arm of the trial he is on. A clinical trial is "Blind" if participants are unaware on whether they are in the experimental or control arm of the study; also called masked.
CLINICAL: Pertaining to or founded on observation and treatment of participants, as distinguished from theoretical or basic science.
CLINICAL INVESTIGATOR: A medical researcher in charge of carrying out a clinical trial's protocol.
CLINICAL TRIAL: A clinical trial is a research study to answer specific questions about vaccines or new therapies or new ways of using known treatments. Clinical trials (also called medical research and research studies) are used to determine whether new drugs or treatments are both safe and effective.
COHORT: In epidemiology, a group of individuals with some characteristics in common.
COMMUNITY-BASED CLINICAL TRIAL (CBCT): A clinical trial conducted primarily through primary-care physicians rather than academic research facilities.
COMPASSIONATE USE: A method of providing experimental therapeutics prior to final FDA approval for use in humans. This procedure is used with very sick individuals who have no other treatment options. Often, case-by-case approval must be obtained from the FDA for "compassionate use" of a drug or therapy.
COMPLEMENTARY AND ALTERNATIVE THERAPY: Broad range of healing philosophies, approaches, and therapies that Western (conventional) medicine does not commonly use to promote well-being or treat health conditions. Examples include acupuncture, herbs, etc.
CONFIDENTIALITY REGARDING TRIAL PARTICIPANTS: Refers to maintaining the confidentiality of trial participants including their personal identity and all personal medical information. The trial participants' consent to the use of records for data verification purposes should be obtained prior to the trial and assurance must be given that confidentiality will be maintained.
CONTRAINDICATION: A specific circumstance when the use of certain treatments could be harmful.
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