Increasing Intensity of On-Site Monitoring a Troubling Trend
Applied Clinical Trials
The percentage of source document verification coverage has been decreasing slightly over the past four years. Therefore, the amount of on-site time required by site monitors should also start decreasing.
SPOTLIGHT EVENTRisk-Based Monitoring – Part Two In Depth ReviewMarch 13, 2014
Cambridge, MassachusettsDownload BrochureRegister
RELATED
- What Do Risk-Based Monitoring and Patient Engagement Have in Common?
- Risk-Based Approach to Monitoring
- Has FDA Guidance on Risk-based Monitoring Impacted SDV Coverage Yet?More in Risk-Based Monitoring
In a recent blog, we presented data highlighting the trend in the percentage of source document verification coverage (i.e., percent of eCRF data targeted for SDV) and in particular observed that it has been decreasing slightly over the past four years, presumably related to early adoption of targeted, risk-based monitoring strategies. While the overall decrease has been relatively modest to-date, one might expect that the amount of on-site time required by site monitors should correspondingly start decreasing.
But this month';s Insights graph tells a different - and somewhat troubling - story. Using the Medidata Insights metrics warehouse- now comprising nearly 2,500 studies from 65 sponsor organizations - annual trends were computed and graphed of two critical monitoring efficiency metrics for Phase II/III studies:
- Monitoring on-site rate—the average number of on-site monitoring days per site per year
- SDV velocity—the average number of eCRF data points SDV'd per on-site day
The data shows that site monitors are spending increasingly more days on-site per year, and performing increasing amounts of SDV during each on-site day. This increasing burden—and cost—of site monitoring and SDV can be attributed to the increasing complexity of protocols observed in recent years. It is another reminder of the serious challenges facing clinical R&D organizations and the need to move more aggressively towards a targeted, risk-based monitoring paradigm.
Medidata is very interested to hear your take on these observed trends. Please also stay tuned as we continue to dig deeper into the Insights data through 2012.
Monitoring rates in Phase II-III trials, 2008-2011.
—Medidata Solutions, - www.mdsol.com
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Phase III PROMINENT Trial Initiated to Evaluate Felzartamab for Primary Membranous Nephropathy
June 30th 2025The global Phase III PROMINENT trial has begun dosing patients to evaluate felzartamab in treating primary membranous nephropathy, a serious autoimmune kidney disorder with no FDA-approved therapies.
Funding Cuts Threaten Diversity in Clinical Research
June 27th 2025In this video interview, Kyle McAllister, co-founder, CEO, Trially, discusses how recent federal funding cuts are likely to undermine research focused on underrepresented populations, and why long-term investment in community-based studies is essential to closing persistent health equity gaps.
