Medical Writing The Data Economy Biostatistics, data management, and medical writing: A multidisciplinary approach to the development of the CTD integrated summaries
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Volume 29, Issue 2 - The Data Economy

Biostatistics, data management, and medical writing: A multidisciplinary approach to the development of the CTD integrated summaries

Abstract

Analyses of integrated databases of efficacy and safety are a Food and Drug Administration (FDA) requirement. They are very useful in evaluating the safety and efficacy data gathered in multiple clinical studies. However, their utility is dependent upon the quality of the studies and the data gathering methods, which affect the quality of the data. It also depends on a scientifically sound strategy for pooling and analysis of the data, and finally, on the adequate reporting of results. Early involvement of professionals from the data management and biostatistics fields can facilitate the development of valuable integrated summary of safety (ISS) and integrated summary of efficacy (ISE) through implementation of study design and data management strategies that are geared toward pooling of data from multiple studies. Medical writers should also join the process early to acquire the knowledge and understanding required for reporting the data in an accurate and meaningful way.

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