Preface
In this book
This book is designed for people who are interested in using Python for clinical development. Each part of the book makes certain assumptions about the readers’ background:
Part 1, titled “Environment and toolchain” and “Reporting packages”, provides general information on setting up Python development environments for clinical reporting.
Part 2, titled “Delivering TLFs in CSR”, provides general information and examples on creating tables, listings, and figures using Python. It assumes that readers are individual contributors to a clinical project with prior experience in Python. Familiarity with data manipulation using Polars is expected. Recommended references for this part include Python Polars: The Definitive Guide, and the rtflite documentation.
Part 3, titled “Clinical trial project”, provides general information and examples on managing a clinical trial A&R project using Python. It assumes that readers are project leads who have experience in Python package development.
Part 4, titled “eCTD submission package”, provides general information on preparing submission packages related to the CSR in the electronic Common Technical Document (eCTD) format using Python. It assumes that readers are project leads of clinical projects who possess experience in Python package development and regulatory submission processes.
Philosophy
We share the same philosophy described in the introduction of the R Packages book (Wickham and Bryan 2023), which we quote below:
- “Anything that can be automated, should be automated.”
- “Do as little as possible by hand. Do as much as possible with functions.”