Entries for the website glossary.
(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 standard procedure, Phase II clinical trials gauge efficacy, and Phase III trials confirm it.
Synonyms: effectivenessBased on experimental data, not on a theory.
The extremely hard covering on the exterior of the teeth.
Overall outcome that a clinical trial protocol is designed to evaluate. Common endpoints are severe toxicity, disease progression, or death.
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.
Synonyms: enrolling, enrolled, recruiting, recruitedThe branch of medical science that deals with the study of incidence and distribution and control of a disease in a population.
(In clinical trials) The process of determining that a proposed clinical trial conforms to a wide range of moral, scientific and ethical standards, to ensure that participants in the trial are not abused, mistreated or unfairly taken advantage of. Before a clinical trial can go ahead, it must be given approval via an independent ethics process.
The medical or social standards determining whether a person may be disqualified from entering 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.
(Of a drug) Not licensed for use in humans, or as a treatment for a particular condition. Experimental drugs are studied in clinical trials to determine their safety and efficacy, and are sometimes made available via Special Access Schemes prior to their approval.
Synonyms: investigational