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Biostatistics, Data Management, and Medical Writing: a Multidisciplinary Approach to the Development of the CTD Integrated Summaries

Published in Medical Writing Magazine, Volume 29 Number 2 | June 2020

Authors: Shiri Diskin, Tanya du Plessis, Ofra Barnett-Griness


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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Medical Writing is a quarterly publication that aims to educate and inform medical writers in Europe and beyond. Each issue focuses on a specific theme, and all issues include feature articles and regular columns on topics relevant to the practice of medical writing. We welcome articles providing practical advice to medical writers; guidelines and reviews/summaries/updates of guidelines published elsewhere; original research; opinion pieces; interviews; and review articles.