Quality Tolerance Limits: An Updated View of Industry Trends
Sylviane de Viron
New data shows the adoption of studies introducing quality tolerance limits continues to surge—and offers clues on focus of implementation.
We presented an
We reported in the previous article that QTLs were implemented in 37.7% of new studies in 2022. This increased to 58.1% in 2023, which confirms that the adoption of QTLs has continued to grow rapidly (see Figure 1). The median number of QTLs per study remained at two, as it was in our previous article.
Additionally, we provided a distribution of the QTLs across three general categories as follows. Results remain very consistent with the updated data.
- Compliance: 55.8% through 2022, up to 62.3% through 2023.
- Enrollment and retention: 32.5% through 2022, down to 29.2% through 2023.
- Safety: 11.3% through 2022, down to 8.5% through 2023.
This year, we have additionally assigned a more specific QTL type for every QTL parameter implemented on the platform, so that we can assess which types are the most commonly used. QTLs for “missed assessment rate” are the most common, occurring in 57.5% of all studies having QTLs. This is followed by “enrolled but ineligible rate” (25.6%) and “early termination rate” (23.6%).
Our data indicated that a strong majority of QTLs being implemented thus far are focused on risks related to data reliability, and more specifically the risk of not having sufficient data to support evaluation of study endpoints. The top four QTL types are arguably in this category, assessing the loss or attrition of evaluable data (or patients) in some form. The fifth QTL type, "safety event of interest rate," appears in 14.6% of studies using QTLs and focuses risks related to patient safety. The QTL type, "lost to follow-up rate" (14.2% of studies), may have implications for both data reliability and patient safety.
Steve Young, Chief Scientific Officer, CluePoints; Sylviane de Viron, Data and Knowledge Manager, CluePoints
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