Author: Sylviane de Viron, Manager, Data & Knowledge, CluePoints
The CluePoints’ Quality Tolerance Limits (QTL) module offers Sponsors and CROs a convenient way to rapidly identify systemic issues and document the approach and any important deviations from the pre-defined QTLs that may be critical to study quality (e.g., impact on safety or reliability of study results).
This module was first released to the CluePoints Monitoring Platform (CMP) in June 2019 to enable effective QTL implementation and support compliance with the expectations established in ICH E6 (R2). Since then, more than 15 organizations and around 50 studies have implemented QTLs in CluePoints, and the rate of adoption has increased each year steadily. For example, in 2019, only 5% of new studies created on the CluePoints platform included QTLs. However, this increased to 9% in 2020 and then 21% during 2021, and data gathered early in 2022 indicates a further acceleration of this trend.
The following are some additional QTL adoption trends that we have compiled:
- For studies implementing QTLs, there is an average of 2.1 QTLs per study, with observed numbers ranging from 1 up to 8.
- For studies implementing QTLs, 94% of them also include KRIs, while 62% include DQA analyses.
- The QTLs implemented thus far are distributed across three general categories as follows:
- Compliance: 46%
- Enrollment & Retention: 43%
- Safety: 11%
Compliance QTLs are primarily focused on Missed Assessments (related to key objectives) and errors in randomization. Enrollment & retention QTLs focus on study and/or treatment discontinuations and enrollment trends (e.g., unbalanced by region, demographics, etc.).
The adoption rate of QTLs within the CluePoints user community is rapidly increasing, and we will continue to compile and periodically share relevant QTL metrics and trends.