Christian Hove Rasmussen (1), Kaori Ito (1), Lynn McFadyen (1), Paula Burger (1), Mike K. Smith (1)
(1) Pfizer, Inc. Groton, CT, USA and Sandwich, Kent, UK
Objectives: The creation of a large report related to a quantitative analysis is often a painstaking and error-prone task, involving hours of manually copying and pasting figures into word processors, transcribing numbers into table cells, etc. Moreover, should the report require updates due to reviewer’s comments or if the analysis needs to be rerun (e.g. due to a data update), the entire procedure needs to be redone and the resulting report subject to further quality control (QC).
Methods: In this poster we present an ongoing effort at Pfizer, Inc. to make reporting simple, reproducible, and user-friendly by utilizing an automated setup of modeling and data analysis combined with the document system LaTeX. The latter is customized to fit the needs of the pharmaceutical industry.
Results: The LaTeX system allows the user to create a publishable PDF document directly from figure image files and tables from CSV text files. This greatly simplifies formatting which is taken care of automatically according to a predefined template. The template has all submission-ready standards built into it and is therefore fully compliant with regulatory expectations. Furthermore, numbering of and references to sections, figures, tables, etc. is automatically updated as the document is written, and citations are loaded directly from e.g. Google Scholar or Medline using the LaTeX-based reference manager JabRef. The time required to create the report is reduced from weeks to days, and updating it to a matter of minutes or hours. This saves crucial time especially if rework is required in the final stages before a regulatory submission. The way we have set it up allows getting started with the document system with no prior knowledge of LaTeX and only a few hours of training.
Conclusions: Using the reproducible research methods above reduces the overhead in creating reports to the required standards; reduces the likelihood of manual transcription errors and focusses QC on technical and scientific issues rather than document preparation issues.
Reference: PAGE 25 (2016) Abstr 5981 [www.page-meeting.org/?abstract=5981]
Poster: Methodology - Other topics