Characterizing Pain Points in Clinical Data Management and Assessing the Impact of Mid-Study Updates.

Therapeutic Innovation & Regulatory Science
Beth HarperKen Getz

Abstract

The causes, degree and disruptive nature of mid-study database updates and other pain points were evaluated to understand if and how the clinical data management function is managing rapid growth in data volume and diversity. Tufts Center for the Study of Drug Development (Tufts CSDD)-in collaboration with IBM Watson Health-conducted an online global survey between September and October 2020. One hundred ninety four verified responses were analyzed. Planned and unplanned mid-study updates were the top challenges mentioned and their management was time intensive. Respondents reported an average of 4.1 planned and 3.7 unplanned mid-study updates per clinical trial. Mid-study database updates are disruptive and present a major opportunity to accelerate cycle times and improve efficiency, particularly as protocol designs become more flexible and the diversity of data, most notably unstructured data, increases.

References

May 2, 2018·Therapeutic Innovation & Regulatory Science·Mary Jo LambertiKen Getz

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