E - G of terms

EFFECTIVENESS: Whether a drug achieves its desired effect in the real world.

EFFICACY: (Of a drug or treatment) the ability of a drug or treatment to produce a beneficial result. A drug demonstrates efficacy if it is effective at the dose tested against the illness for which it is prescribed.

ELIGIBILITY CRITERIA: Summary criteria for participant selection; includes inclusion and exclusion criteria.

EMPIRICAL: Based on observation or experience, not experimental data.

ENDPOINT: Overall outcome that the protocol is designed to evaluate.

ENUCLEATION: A surgical procedure to completely remove the eye, keeping it and the surrounding muscles and orbital structures intact.

EPIDEMIOLOGY: The branch of medical science that deals with the study of incidence, distribution and control of a disease in a population.

ETHICS COMMITTEE: See institutional review board or "IRB" definition below

EUROPEAN MEDICINES AGENCY (EMA): The European regulatory agency responsible for the scientific evaluation of applications for European marketing authorization for medicinal products (centralized procedure). EMEAŹ¼s main mission is to protect and promote public and animal health, through the evaluation and supervision of medicines for human and veterinary use.

EXCLUSION/INCLUSION CRITERIA: The medical or social standards determining whether a person may or may not be allowed to enter a clinical trial. These criteria are based on such factors as age, gender, pregnancy status, 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 to ensure the integrity of the study and to keep them safe.

EXENTERATION: The complete surgical removal of the eyeball and other contents of the eye socket.

EXPANDED ACCESS: Refers to any of the regulatory authority procedures, such as compassionate use, parallel track, and treatment Investigational New Drug Application.

EXPERIMENTAL/INVESTIGATIONAL DRUG: A drug that has been authorized for use in a clinical trial but has not been granted marketing approval as a treatment for a particular use.

EXTRA-HEPATIC: Outside the liver. Extra-hepatic disease in cancer refers to lesions that appear outside the liver.

EYE CANCER: Broadly used to describe cancers that arise in or around the eye. Sometimes used interchangeably with OCULAR MELANOMA or UVEAL MELANOMA. Eye cancers can also include diseases such as RETINOBLASTOMA, a childhood cancer of the eye.

FINE-NEEDLE ASPIRATION BIOPSY: Fine-needle aspiration is a diagnostic procedure used to investigate lumps or masses, in this case one on the inside of the eye. In this technique, a thin, hollow needle is inserted into the mass for sampling of cells that, after being stained, will be examined under a microscope and their genetic makeup determined. The genetic makeup of an eye tumour is a good indicator of possible future metastatic spread.

FIRST-IN-HUMAN/MAN STUDY: A clinical trial where a medical procedure or medicinal product, previously developed and assessed through laboratory model or animal testing, or through mathematical modeling is tested on human subjects for the first time.

FOOD AND DRUG ADMINISTRATION (FDA): The U.S. Department of Health and Human Services agency responsible for ensuring the safety and effectiveness of all drugs, biologics, vaccines, and medical devices. The FDA also works with the blood banking industry to safeguard the nation's blood supply.

GAMMA KNIFE: Not a knife at all, but a set of focused beams of gamma radiation used to treat lesions, usually those in the brain. The various beams of radiation enter the brain at several different locations so that only a relatively small dose is received in any given area, except the place where they are focused which receives a large dose of radiation in the expectation that the lesion is destroyed. This is an example of STEREOTACTIC RADIOSURGERY.

GENERIC DRUGS: A medicine with the same active ingredient, but not necessarily the same inactive ingredients, as a brand-name drug. A generic drug may be marketed only after the original drug's patent has expired.


GUT MICROBIOME: Gut microbiota (also called gut flora) is the name given today to the microbe population living in our intestine. Our gut microbiota contains tens of trillions of microorganisms, including at least 1000 different species of known bacteria and collectively the environment is known as the gut microbiome. The gut microbiome is known to be related to the effectiveness of our immune system, although exactly how this mechanism works is not well known and currently there are no proven ways to enhance immune response by altering it.