Thomas Frank (1), Ashley Strougo (1), Klaus Lindauer (1), Diether Rueppel (1), Heiner Speth (2)
(1) Sanofi, R&D Operations/Translational Medicine and Early Development (TMED), Pharmacokinetics, Pharmacodynamics and Metabolism Germany, M&S, (2) Sanofi, R&D Operations/TMED, Global Applications
Objectives: The writing of population analyses reports fulfilling the specifications of submission readiness is a time-consuming process and highly subjective to human errors. In order to ease this process and diminish the likelihood of error we have been using LaTeX to write these reports. The objective of this poster is to share our concept and our latest 10 years’ experience in using LaTeX to write population analyses reports.
Methods: The document preparation system LaTeX (TeX Live) has been in use internally for about 20 years to write population analysis reports. The templates were maintained and further developed over the years in order to enable newer functions and improvements of TeX Live, to comply with regulatory requirements, and to ensure simplification that allows less experienced LaTeX users to benefit from the template. The current template version is based on ‘scrartcl’ document class of KOMA-Script (TeX Live 2017 for Linux). It essentially consists of one master file that inputs multiple sub-files representing the textual content of each section of the report. Each file is provided with example text and clear guidance to allow modifications. In general, users only need to modify the sub-files to insert specific information on the analysis performed. Future-safe TeX Live packages like ‘biblatex/biber’ and ‘glossaries’ manage bibliographic data and/or definitions of terms/abbreviations. The rendition of one single PDF file, including creation of reference list and list of abbreviations proceeds automatically by using ‘make’ program. Our LaTeX template is maintained in an internal git repository that enables a shared and version-controlled update.
Results: Over the last 10 years, 28 reports have been issued in the corporate document management system, whereof 27 are part of Common Technical Documents (CTDs). Over the years LaTeX has remained open-source software and found to be very stable. The use of LaTeX-based report writing was found to facilitate the work not only of the author of the report, but also of the Quality Control (QC) reviewer and the coordination group responsible for the submission readiness of the report. For the author, one of the main advantages of using the LaTeX-based report is the easiness in insertion of tables and figures and the creation of the extensive appendices. High-resolution figures and tables can be inserted seamlessly by simple commands and the path to the files. Figures can be inserted in their native PDF format without resulting in an unnecessarily inflation of the size of the report source file or need for prior conversion of graphics file format. As a consequence, updating tables and figures becomes a much easier task. For the QC reviewer, the advantage of using LaTeX-based report lies on the fact that every step in the process is documented and reproducible. Finally, the document coordination group within Sanofi has also benefit from our LaTeX-based reports since there are never formatting issues or rework to be done. Adaptations due to changes in corporate layout guidelines can also be made very easily. In the past we have had some negative feedback from reviewers due to the fact that no MS Word version was available to allow review using ‘track changes’. This issue was almost fully resolved by the advances of tools for commenting in PDF documents. For successful implementation of LaTeX in report writing the team should have at least one expert on the topic who offers comprehensive user support either individually or via channels, e.g., wiki pages, written user guides and regular tutorials.
Conclusions: Our concept for the template was developed in a way that proved to be simple enough to allow non experienced LaTeX users to benefit from it. The advantages of using LaTeX-based report writing are found to overweight the few disadvantages. In general, our group has a very positive experience in using LaTeX-based report writing, and we tend to continue using it in the future.
Reference: PAGE 27 (2018) Abstr 8431 [www.page-meeting.org/?abstract=8431]
Poster: Methodology - Other topics