–Written by Rabia Ahmad, GSK
Back in April 2021, I introduced PHUSE Education “Therapeutic Area” cluster in my blog “PHUSE Education – Therapeutic Areas & Clinical Documents Clusters”. The cluster aims to help clinical data scientists (CDS) gain basic insights to the key components specific to various therapeutic areas (TAs). It does so by providing TA overview documents containing topics such as, disease description, industry standards, links to regulatory documents and sites, endpoints, study design, etc.
The Therapeutic Area cluster team is proud to announce the release of its first document – “Overview: Oncology”. We hope CDSs, particularly those new to Oncology, find the introduction and references useful. The document contains the following sections:
- Overview
- Description of Disease
- Types of Cancers
- Types of Cancer Treatments
- Demographics and Baseline Characteristics
- CDISC Standard TAs and Therapeutic Area User Guides (TAUGs)
- Agency Guidelines (e.g., the EMA, FDA, PMDA)
- Study Design
- Endpoints and Assessments (Key Efficacy and Safety SDTMs & ADaMs)
- Endpoints
- Assessments (Key Efficacy and Safety SDTMs & ADaMs)
- Data Challenges
- Recommended PHUSE Education Material
- Recommended Reading
- References
Please note that, “Overview: Oncology” does not provide a comprehensive overview of oncology therapeutic area; rather it is an introduction to the TA and contains useful links for programmers to get familiar with oncology studies and its requirements.
To help us improve our future deliverables, we would love to hear your feedback. To share ideas or to get involved in one of the Education clusters, reach out to us at education@phuse.global or contact Sascha Ahrweiler at sascha.ahrweiler@phuse.global.
Happy reading!
