Services- Using Item Libraries
Home – Using item libraries
🧾 Leveraging Item Libraries to Build Fit-for-Purpose QOL Measures
Customizable, validated content for oncology-focused Clinical Outcome Assessments (COAs)
In modern oncology trials, the ability to tailor Quality of Life (QOL) and Patient-Reported Outcome (PRO) measures to specific disease contexts is becoming increasingly valuable. One of the most effective ways to do this is through the use of item libraries—structured pools of validated QOL items developed by organizations such as EORTC and PROMIS.
At Bottomley Consulting Group (BCG), we have extensive experience in using item libraries to support sponsors in building fit-for-purpose COA tools that meet regulatory and clinical needs.
What Are Item Libraries?
Item libraries are curated collections of validated QOL questions (“items”) that can be used to:
Customize instruments for specific tumor types or treatment modalities
Reduce redundancy while maintaining scientific rigor
Adapt to emerging endpoints or novel therapies in early- or late-phase trials
These libraries are widely accepted by regulatory authorities and increasingly used in global oncology trials to increase flexibility while maintaining measurement precision.
How BCG Can Help
We support sponsors in:
Selecting items from libraries such as EORTC Item Library, PROMIS, or PRO-CTCAE
Developing new QOL measures based on tailored item sets
Supporting psychometric validation and endpoint strategy
Advising on documentation for regulatory and HTA submission
Providing guidance on data integration, analysis, and interpretation
We ensure that your item selection is targeted, validated, and aligned with both patient priorities and trial objectives.
Evidence-Based and Current standards
Our work is grounded in the latest scientific knowledge. We regularly publish and contribute to open-access resources that help sponsors stay up to date with current best practices.
📖 Looking for more? Ask us about our most recent publication on QOL item library applications in oncology.
Let’s Design Measures That Matter
Whether you’re building a new PRO tool or customizing an existing one, Bottomley Consulting Group can help you get it right—from concept through implementation.
📩 Contact Us to explore how item libraries can enhance your QOL measurement strategy.