Glossaries | EUPATI Open Classroom

Friday, 1 November 2024, 1:35 AM

Site: EUPATI Open Classroom

Course: EUPATI Open Classroom (EUPATI Open Classroom)

Glossary: Glossary

Effectiveness

The capability of a medicine to produce a desired or expected effect in the real world clinical setting. When talking in terms of efficacy vs. effectiveness, effectiveness relates to how well a treatment works in the practice of medicine, as opposed to efficacy, which measures how well a treatment works in clinical trials or laboratory studies.

Efficacy

Efficacy refers to the ability of a medicine to provide a beneficial effect (a positive benefit/risk ratio) when studied in a clinical trial. When talking in terms of efficacy vs. effectiveness, effectiveness relates to how well a treatment works in the real world practice of medicine, as opposed to efficacy, which measures how well a treatment works in clinical trials or laboratory studies.

Efficiency

In the context of health economics, efficiency of a medicine is a measure of its ability to provide a beneficial effect against its costs to individuals or society. The most efficacious treatment may not be the most efficient (cost-effective) option, for example making it unaffordable for the patients or the health system to implement.

Electrocardiogram

Electroconvulsive Therapy

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.