- efficacysearch for term
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(Of a drug or treatment). The maximum ability of a drug or treatment to produce a result regardless of dosage. A drug passes 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 standard procedure, Phase II clinical trials gauge efficacy, and Phase III trials confirm it. trials if it is effective at the dose tested and against the illness for which it is prescribed. In the standard procedure, Phase IIA smaller clinical trial designed to establish whether a drug is effective. Phase II studies are conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks. If there is evidence that the drug is effective, a Phase III study is undertaken, with a larger number of participaants, to confirm this. clinical trials gauge efficacy, and Phase IIIA large clinical trial designed to establish whether a drug is effective and safe enough for widespread use. Phase III studies include expanded controlled and uncontrolled trials after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug and provide and adequate basis for physician labeling. trials confirm it.
Synonyms: effectiveness
- empiricalsearch for term
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Based on experimental(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. data, not on a theory.
- enamelsearch for term
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The extremely hard covering on the exterior of the teeth.
- endpointsearch for term
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Overall outcome that a clinical trialA clinical trial is a research study to answer specific questions about vaccines or new therapies or new ways of using known treatments. Clinical trials are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people. Trials are in four phases: Phase I tests a new drug or treatment in a small group; Phase II expands the study to a larger group of people; Phase III expands the study to an even larger group of people; and Phase IV takes place after the drug or treatment has been licensed and marketed. protocolA study plan on which all clinical trials are based. The plan is carefully designed to safeguard the health of the participants as well as answer specific research questions. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. While in a clinical trial, participants following a protocol are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment is designed to evaluate. Common endpoints are severe toxicity, disease progression, or death.
- enrolmentsearch for term
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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 consentThe 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. process.
Synonyms: enrolling, enrolled, recruiting, recruited
- epidemiologysearch for term
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The branch of medical science that deals with the study of incidence and distribution and control of a disease in a population.
- ethicssearch for term
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(In clinical trials) The process of determining that a proposed clinicalPertaining to or founded on observation and treatment of participants, as distinguished from theoretical or basic science. 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(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. process.
- exclusion criteriasearch for term
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The medical or social standards determining whether a person may be disqualified from entering a clinical trialA clinical trial is a research study to answer specific questions about vaccines or new therapies or new ways of using known treatments. Clinical trials are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people. Trials are in four phases: Phase I tests a new drug or treatment in a small group; Phase II expands the study to a larger group of people; Phase III expands the study to an even larger group of people; and Phase IV takes place after the drug or treatment has been licensed and marketed. . 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 criteriaThe 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. are not used to reject people personally, but rather to identify appropriate participants and keep them safe.
See also: inclusion criteria
- experimentalsearch for term
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(Of a drug) Not licensed for use in humans, or as a treatment for a particular condition. Experimental(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. drugs are studied in clinical trials to determine their safety and 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 standard procedure, Phase II clinical trials gauge efficacy, and Phase III trials confirm it., and are sometimes made available via Special Access Schemes prior to their approval.
Synonyms: investigational