Glossary of Clinical Research - N

N

• National Institutes of Health

NIH. A federal agency in the U.S. that conducts biomedical research in its own laboratories; supports the research of non-Federal scientists in universities, medical schools, hospitals, and research institutions throughout the country and abroad; helps in the training of research investigators; and fosters communication of medical information. Access the National Institutes of Health Web site at http://www.nih.gov. Also called NIH. (NCI)

• Natural history study

• A study that follows a group of people over time who have, or are at risk of developing, a specific medical condition or disease. A natural history study collects health information in order to understand how the medical condition or disease develops and how to treat it. (NCI)
• Study of the natural development of something (such as an organism or a disease) over a period of time. (NLM)

• New Drug Application (NDA)

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

• Nonblinded

Describes a clinical trial or other experiment in which the researchers know what treatments are being given to each study subject or experimental group. If human subjects are involved, they know what treatments they are receiving. (NCI)

• Nonclinical Study

Biomedical studies not performed on human subjects. (ICH E6)

• Nonconsecutive case series

A clinical study that includes some, but not all, of the eligible patients identified by the researchers during the study registration period. This type of study does not usually have a control group. (NCI)

• Non-inferiority trial

A trial with the primary objective of showing that the response to the investigational product is not clinically inferior to a comparative agent (active or placebo control). (ICH E9)

• Nonrandomized clinical trial

A clinical trial in which the participants are not assigned by chance to different treatment groups. Participants may choose which group they want to be in, or they may be assigned to the groups by the researchers. (NCI)