Establishing Consistent Programming for Pharmaceutical Safety Summarizations Using a DOW Loop
Bradford J. Danner, Steven R. Kirby · 2008
Three types of data collected during an early stage clinical trial study to assess safety are laboratory tests, electrocardiogram parameters, and vital signs. Simple summary statistics of the results and change from baseline are usually presented in an ICH summary report, and it is also useful to include a presentation of out of range shifts relative to baseline. When several varieties of standard programs are available to facilitate summaries, a consistent approach across all datasets and types of summaries in a study could increase efficiency and minimize the possibility of multiple errors. This paper will illustrate an approach which may be applied to various types of data regardless of vertical or horizontal structure. To minimize data step processing and superfluous merging or processing, a DOW loop is employed. Advantages and disadvantages of using this process are discussed, and preliminary results to date are presented.