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.
A best-in-class drug refers to a follow-on drug that is considered superior within an established mechanism of action, providing improved efficacy, safety, patient compliance, and/or reducing the costs or burden of treatment when compared to a first-in-class (FIC) or previous best-in-class (BIC) drug. These drugs may become the new gold standard in their therapeutic area by demonstrating therapeutic superiority without compromising safety or quality of life, making them the preferred choice of treatment