Term of the Day
Natural History Study
A natural history study is a preplanned intended to track the course of the disease. Its purpose is to identify demographic, genetic, environmental, and other variables (e.g., treatment modalities, concomitant medications) that correlate with the disease’s development and outcomes. Natural history studies are likely to include patients receiving the current standard of care and/or emergent care, which may alter some manifestations of the disease.
Investigational medicinal product
Investigational medicinal product means a medicinal product which is being tested or used as a reference, including as a placebo, in a clinical trial.