Central Monitoring Use in Early-Phase and Small Enrollment Trials
A review of industry methods and adoption trends in those trial segments.
Central monitoring is highly effective in detecting emerging quality issues in clinical trials, but debate continues over its use in early-phase and small enrollment studies due to typically lower data volumes and shorter study timelines. In this analysis, we summarized industry trends in early-phase and small trials using data from the CluePoints central monitoring platform. Out of the 1,062 studies using the platform, 140 were Phase I (13%), 378 were Phase II (36%), and across all phases we observed 175 trials with 100 or fewer enrolled patients (16%) and 65 more with 50 or fewer enrolled patients (6%).
Three key methods are commonly used for central monitoring: Statistical data monitoring (SDM), key risk indicators (KRIs), and quality tolerance limits (QTL).* Figure 1 (see below) illustrates the adoption rates of these three methods in early-phase and small trials. For comparison, we also calculated the adoption rates across all studies using the central monitoring platform, categorized as “overall.”
- SDM: The overall adoption rate for the SDM tool is 78%. Phase I and II trials show a very similar adoption rate (73% and 79%, respectively), while small trials have a slightly lower adoption rate (67% for trials with ≤100 patients and 48% for trials with ≤ 50 patients).
- KRI: The KRI tool has an overall adoption rate of 89%, which is similar to the adoption in Phase I, Phase II trials, and small trials.
- QTL: The overall adoption rate for the QTL tool is at 32%, while Phase I, Phase II trials, and small trials with ≤ 50 patients show a higher adoption rate of 46%, 38%, and 38%, respectively. In small trials with ≤100 patients, the adoption of QTL is very similar to the overall rate. Note, the lower overall adoption to QTL can be attributed to its more recent introduction in the industry.
Takeaways
The use of KRIs is very consistent across clinical trial phases and sizes, indicating that study phase or size does not influence the use of KRIs. SDM adoption is lower in small studies, which is expected given the smaller data volumes available for statistical comparison in these trials.
Importantly, QTL adoption is significantly higher in Phase I and Phase II trials, highlighting the emphasis clinical study teams place on early detection of study-level issues in these critical trial phases.
Steve Young, Chief Scientific Officer; Sylviane de Viron, Data and Knowledge Manager; both with CluePoints
* Definitions:
- SDM involves unsupervised statistical assessment of all collected clinical trial data.
- KRIs focus on pre-identified risks primarily at the site level (but also at the patient, country, and/or study levels).
- QTLs exclusively target study-level risks.
