Dynamic Text and Automatic Formatting – An R Package to Streamline Time-sensitive Formal Reports

Caesar Li Co-Author
Johnson & Johnson
 
Antoine Stos Co-Author
Johnson & Johnson
 
Yannick Vandendijck Co-Author
Johnson & Johnson
 
Surya Mohanty Co-Author
 
Lauren Crow Co-Author
 
Xiang Li First Author
Johnson & Johnson
 
Lauren Crow Presenting Author
 
Monday, Aug 4: 2:20 PM - 2:35 PM
1211 
Contributed Papers 
Music City Center 
Topline results (TLR) in clinical trials promptly disclose key trial findings to stakeholders following primary analyses. RapTLR enhances TLR generation using functions to manipulate .docx objects. In R, users can navigate the document, modify or create content, and embed interactive appendices, significantly boosting efficiency, accuracy, and objectivity. Incorporating in-text calculations in R ensures precision by eliminating errors from manual data entry, which is crucial during updates from database releases or changes in parameter specifications. RapTLR streamlines appendix construction by allowing users to automatically (1) convert outputs into .docx objects (2) add bookmarks to each output ID (3) append outputs to the report, and (4) create a table of contents that includes bookmarked links for smooth navigation. To ensure objectivity and timeliness in reporting, the program must be set up well before database lock so that results do not impact the pre-planned structure of the TLR. Additionally, multiple statisticians can run the same program and obtain the same results. RapTLR package saves statisticians time while improving quality in a critical phase of a clinical trial.

Keywords

R

Clinical Trials

Pharmaceuticals

Automation

R Package

git 

Main Sponsor

Biopharmaceutical Section