The European Medicines Agency is a decentralized body of the European Union (EU) with headquarters in London. Its main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use. The European Medicines Agency is responsible for the [...]
An independent group of both medical and non-medical professionals who are responsible for verifying the integrity of a study and ensuring the safety, integrity, and human rights of the study participants.
The branch of medical science that deals with the study of incidence and distribution and control of a disease in a population or sub-population. Epidemiological studies can also be designed to evaluate medicine safety.
European Organization for Research and Treatment of Cancer
see European Medicines Agency
The ability of a medicine or treatment to produce a result. A medicine passes efficacy trials if it is effective at the dose tested and against the illness for which it is prescribed. In the procedure mandated by the FDA, Phase 2 clinical trials gauge efficacy, and Phase 3 trials confirm it.
The dose of an investigational agent that produces the outcome considered “effective,” as defined in the study protocol. This could mean a cure of the disease in question or simply the mitigation of symptoms.