Glossary


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E

Electrocardiogram

Electrocardiogram

Electroconvulsive Therapy

Electroconvulsive Therapy

Elements to Assure Safe Use

Elements to Assure Safe Use

Eligibility

Eligibility in medicines development usually refers to the requirements that participants must meet in order for them to have the possibility of being selected to participate in a clinical trial. The requirements (criteria) will typically contain not only elements which allow participation (inclusion criteria) but also details of what will prevent someone from participating (exclusion criteria).

Endocrine Therapy

Endocrine therapy, or hormone therapy, is a therapy that adds, blocks, or removes hormones in order to treat a disease. For certain conditions (such as diabetes or menopause), hormones are given to adjust low hormone levels. Hormones can also be given to block the production of natural hormones and to slow or stop the growth of certain cancers (such as prostate and breast cancer).

Endpoint

The endpoint of a clinical trial is a pre-defined event: for instance, the occurrence of a disease, the occurrence of a symptom, or a particular laboratory result. Once someone reaches the endpoint, they are generally excluded from further research in the trial.

Endpoints can be hard (objective) or soft (subjective). In some cases they can be replaced by surrogate endpoints. The endpoints used in a trial must be defined and documented as part of the trial protocol.

Epidermal Growth Factor Receptor

Epidermal Growth Factor Receptor

Epigenetics

Epigenetics is the study of changes in gene activity (expression) that do not involve changes in the underlying DNA sequence (genotype). Epigenetic changes are a regular and natural occurrence, but they can also be influenced by several factors “ including age, environment/lifestyle, and disease state “ through mechanisms that switch genes on or off.

Epigenomics

Epigenomics is the study of the complete set of epigenetic modifications on the genetic material of a cell, known as the epigenome. The epigenome marks the genome in two main ways, both of which play a role in turning genes on or off.

In epigenomics, researchers try to chart the locations and understand the functions of all the chemical tags that mark the genome. Epigenomic maps may someday help doctors make diagnoses and tailor a patient's response to therapies.

Equity considerations

An assessment of how adoption of the new therapy might impact measures of fairness within the health system. For example, will the therapy lead to more benefits for people who are socially or economically disadvantaged?


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