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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 II clinical trials gauge efficacy, and Phase III trials confirm it (See Food and Drug Administration (FDA), Phase II and III Trials).

ELIGIBILITY CRITERIA: Summary criteria for participant selection; includes Inclusion and Exclusion criteria. (See Inclusion/Exclusion Criteria)

EMPIRICAL: Based on experimental data, not on a theory.

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

ENROLLING: The act of signing up participants into a study. Generally this process involves evaluating a participant with respect to the eligibility criteria of the study and going through the informed consent process.

EPIDEMIOLOGY: The branch of medical science that deals with the study of incidence and distribution and control of a disease in a population.

EXCLUSION/INCLUSION CRITERIA: See Inclusion/Exclusion Criteria.

EXPANDED ACCESS: Refers to any of the FDA procedures, such as compassionate use, parallel track, and treatment IND that distribute experimental drugs to participants who are failing on currently available treatments for their condition and also are unable to participate in ongoing clinical trials.

EXPERIMENTAL DRUG: A drug that is not FDA licensed for use in humans, or as a treatment for a particular condition (See Off-Label Use).

FDA: See Food and Drug Administration.

FOOD AND DRUG ADMINISTRATION (FDA): The U.S. 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/.

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

INCLUSION/EXCLUSION CRITERIA: The medical or social standards determining whether a person may or may not be allowed to enter a clinical trial. These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. It is important to note that inclusion and exclusion criteria are not used to reject people personally, but rather to identify appropriate participants and keep them safe.

IND: See Investigational New Drug.

INFORMED CONSENT: The process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study.

INFORMED CONSENT DOCUMENT: A document that describes the rights of the study participants, and includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document. The participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time.

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 U.S. 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.

INTERVENTION NAME: The generic name of the precise intervention being studied.

INTERVENTIONS: Primary interventions being studied: types of interventions are Drug, Gene Transfer, Vaccine, Behavior, Device, or Procedure.

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.

IRB: See Institutional Review Board.

MASKED: The knowledge of intervention assignment. See Blind

NATURAL HISTORY STUDY: Study of the natural development of something (such as an organism or a disease) over a period of time.

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.

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