Clinical Trials Knowledge Center – Articles, FAQ & Glossary

Welcome to the Knowledge Center, designed to give you immediate access to timely and relevant information about clinical trials. Here, you will find frequently asked questions, podcasts, a glossary of clinical trial terms, clinical trial articles, and much more – all to keep you informed and aware.

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Clinical Trials Frequently Asked Questions

Clinical Trial Glossary

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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.

ELECTROCARDIOGRAM:

An electrocardiogram, or EKG, is a painless test that records the heart's electrical activity. With each heartbeat, an electrical signal spreads from the top of the heart to the bottom. As it travels, the signal causes the heart to contract and pump blood. The process repeats with each new heartbeat. An EKG shows how fast the heart is beating; whether the rhythm of the heartbeat is steady or irregular; and the strength and timing of electrical signals as they pass through each part of the heart.

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 for 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.

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Information included in the Glossary is from Clinicaltrials.gov, which uses content from AIDSinfo, CenterWatch, Inc., ECRI, Eli Lilly and Company, MediStudy.com, Inc. and National Cancer Institute.