Clinical trials

Clinical trials

Clinical trials are sets of tests performed for medical research and drug development which is used to extract safety and efficacy data.

Industry: Medical devices; Pharmaceutical

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Clinical trials

Natural history study

Pharmaceutical; Clinical trials

Study of the natural development of something (such as an organism or a disease) over a period of time.

New drug application (nda)

Pharmaceutical; Clinical trials

An application submitted by the manufacturer of a drug to the FDA - after clinical trials have been completed - for a licence to market the drug for a specified indication.

Off-label use

Pharmaceutical; Clinical trials

A drug prescribed for conditions other than those approved by the FDA.

Open-label trial

Pharmaceutical; Clinical trials

A clinical trial in which doctors and participants know which drug or vaccine is being administered.

Orphan drugs

Pharmaceutical; Clinical trials

An FDA category that refers to medications used to treat diseases and conditions that occur rarely. There is little financial incentive for the pharmaceutical industry to develop medications for ...

Peer review

Pharmaceutical; Clinical trials

Review of a clinical trial by experts chosen by the study sponsor. These experts review the trials for scientific merit, participant safety, and ethical considerations.

Initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include ...