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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

Analysis data model (ADaM)

ADaM (Analysis Data Model) datasets are a standardized format for analyzing and reporting clinical trial data. ADaM is a model that defines a set of standard domains, or categories, for analysis, such as Demographics, Adverse Events, Efficacy, and others. Each domain in ADaM includes a set of predefined variables, or data fields, that are used to describe and record the data for that domain in a format that is optimized for statistical analysis.

Unlike SDTM datasets, which are used to organize and submit data to regulatory agencies, ADaM datasets are used for data analysis and reporting. ADaM datasets are typically created by mapping data from SDTM datasets to the standard domains and variables defined in the ADaM model. This process involves converting the data from SDTM format to a format that is optimized for statistical analysis, while ensuring that the data is consistent and accurate.ADaM datasets are used by statisticians to analyze clinical trial data and to generate statistical reports that are included in regulatory submissions. By standardizing the format of clinical trial data for analysis and reporting, ADaM datasets help to ensure the accuracy and consistency of study results, which is essential for evaluating the safety and efficacy of new treatments and therapies.