ACORI | Dictionary: $E

Early Patient Withdrawal

Early patient withdrawal/dropout/discontinuation is when a participant leaves a clinical study before all the required protocol-required elements of the clinical study are completed.

Early Phase

An early phase trial is the first clinical trial of a new treatment performed on humans. It only uses a very small number of participants and low doses for a limited time. The goal is to assess safety, not whether the treatment is effective.

Early Phase 1

Early phase 1 is sometimes conducted before a phase 1 clinical study begins to investigate how or whether a medicine affects the body. They involve very limited human exposure to the medicine (low doses) and have no therapeutic or diagnostic goals.

Eastern Cooperative Oncology Group (ECOG) Performance Status

The ECOG Scale of Performance Status is a crude way to measure a participant's level of functioning in terms of: their ability to care for themself, perform daily activities (walking, working, etc.), and their general physical ability. It is often used as part of clinical study eligibility in order to ensure participants are suitably healthy for a particular clinical study. It is rated from 0-5 in the following manner: 0 Fully active, able to carry on all pre-disease performance without restriction 1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (e.g., light house work, office work) 2 Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours 3 Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours 4 Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair 5 Dead * (Oken, M.M., Toxicity And Response Criteria Of The Eastern Cooperative Oncology Group. Am J Clin Oncol 5:649-655, 1982.)

Effect

Effect is any response or change in a study participant's health or condition that is directly or indirectly caused by the treatment being studied.

Effectiveness

Effectiveness is the extent that a medicine or treatment cures or reduces the severity of a targeted disease or condition and/or its symptoms, as demonstrated by substantial evidence from adequate and well-controlled investigations and observational studies.

Efficacy

Efficacy is the extent that a medicine or treatment cures or reduces the severity of a targeted disease or condition and/or its symptoms, as demonstrated by substantial evidence from adequate and well-controlled investigations and observational studies.

Electronic Health Record (EHR)

Electronic health records exist within one healthcare organization to store information about the patients they are treating and/or have treated.

Electronic Medical Record (EMR)

Electronic medical records exist within one healthcare organization to store information about the patients they are treating and/or have treated.

Eligibility Criteria

Eligibility criteria are rules set by those that run clinical studies in order to clarify who will be included in a study and who will not be included based on information about the potential participant. For example, some studies only accept people over the age of 40 years.

Emergency Use Authorization

Emergency use authorization is when the Food and Drug Administration approves emergency use of certain unapproved medical products or the unapproved use of an approved medical product for certain emergency circumstances, when applied for as a declared health emergency.

Endemic Disease

Endemic disease is the constant presence or usual prevalence of a disease within a given geographic area or population group.

Endpoint

Clinical endpoints are outcome measures that reflect disease, symptoms, signs, or laboratory abnormalities which are the target outcomes in clinical studies. (Note: The term may also refer to any disease or sign that strongly motivates withdrawal of an individual from the study, often called a humane endpoint.)

Enrolled

Clinical study participants are enrolled when they officially agree to participate in a study, have completed the informed consent process, and met eligibility criteria as specified in the protocol.

Enrollment

Enrollment is the time when a clinical study participant officially enters into a clinical study. They have signed the required consent forms and met all inclusion/exclusion criteria. The same term may also be used to define the number of participants in a clinical study.

Epoch

Epoch refers to planned and specific stages of a clinical study. Typical epochs are: a) determination of a potential participant's eligibility, b) time of exposure to treatment, c) time participants are monitored after treatment has ended.

Equity

Equity ensures that anyone, regardless of race, creed, color, or socioeconomics, has an equal opportunity to be eligible for participating in a particular clinical study.

Equivalence Trial

Equivalency trials compare two or more treatments with the goal of showing that the different affects of these treatments is not clinically significant, meaning the treatments do not differ substantially in terms of how they affect the condition they are intended to treat.

Ethics Committee

An ethics committee is a group whose purpose is to protect research participants by monitoring and reviewing clinical studies regularly to ensure participants are safe and well informed about the study, including risks and benefits and potential side effects.

European Medicines Agency (EMA)

The European Medicines Agency is an agency of the European Union that oversees the use of medicinal products, similar to the U.S. Food and Drug Administration.

Events

Events are planned activities (e.g., randomization and study completion) and unplanned occurrences (e.g., adverse events. progression, treatment failure, death)that occur during the clinical study or prior to the clinical study (e.g., medical history).

Exclusion/Inclusion Criteria

Exclusion/inclusion criteria are rules established by the clinical study design that specify who can and who cannot participate in a clinical study, These criteria are designed so as to ensure the health and safety of participants and also so that enrolled participants have the characteristics that will enable investigators to maximize the quality and utility of the results of the clinical study.

Expanded Access

Expanded access is a way for patients with serious diseases or conditions who cannot participate in a clinical study to gain access to a medical product that has not been approved by the Food and Drug Administration.

Expanded Access Type

Expanded access type describes the category of expanded access under Food and Drug Administration regulations.

Expanded Access Type: Individual Patients

"""Expanded access type: individual patients"" allows a single patient"

Expanded Access Type: Intermediate-size Population

"""Expanded access type: intermediate-size population"" allows more than one patient access to a medicine or biological product that has not been approved by the Food and Drug Administration. This type of expanded access is used when multiple patients with the same disease or condition seek access to a specific unapproved medicine or biological product. (CTG) """

Expanded Access Type: Treatment Investigational New Drug (IND)/Protocol

"""Expanded access type: treatment investigational new drug (IND)/protocol"" allows a large"

Expanded Access: Approved for Marketing

"""Expanded access: approved for marketing"" is when the intervention has been approved by the U.S. Food and Drug Administration for use by the public. (CTG) """

Expanded Access: Available

"""Expanded access: available"" is when expanded access is currently available for this investigational treatment"

Expanded Access: No Longer Available

"""Expanded access: no longer available"" is when expanded access was available for this intervention previously but is not currently available and will not be available in the future. (CTG) """

Expanded Access: Temporarily Not Available

"""Expanded access: temporarily not available"" is when expanded access is not currently available for this intervention but is expected to be available in the future. (CTG) """

Experimental Arm

An experimental arm is the group of participants that receives the intervention/treatment that is being tested or evaluated in the clinical study.

Exploratory Study

An exploratory study is a phase 1 or 2 clinical trial that determines the effectiveness and safety of a treatment in groups of generally less than 300 participants.

Exposure

Exposure is when a clinical study participant comes in close contact with a medicinal product, chemical, pathogen, radioisotope, or other substance.

Extension Request

In certain circumstances, a sponsor or investigator may request an extension to delay the standard results submission deadline (generally one year after the primary completion date). The request for an extension must demonstrate good cause. All requests must be reviewed and granted by the National Institutes of Health. (CTG)

Extent of Exposure

Extent of exposure is the extent to which a clinical study participant was exposed to a medicinal product, chemical, pathogen, radioisotope, or other substance. It takes into consideration the strength, dose, duration, frequency, route, and other factors.

Clinical Research Terms Glossary

Terms starting with E