A recent article in the Journal of Clinical Studies Volume 6, issue 2, 2014* discussed the applicability of new FDA and EMA recommendations for risk-based monitoring. Knowing that greater than 30 per cent of a clinical budget is allocated to cover monitoring costs and more than 50 per cent of that is spent on source document verification (SDV), risk-based monitoring allows companies to more effectively target and prioritize resources around identifiable risks that might compromise the quality and integrity of clinical trials data.
Based on general wisdom that Emerging Regions are less experienced in clinical trials, it would be expected that the sites within these regions require more attention, and monitoring in order to ensure the quality of the data collected.
The authors decided to analyses 6500 studies conducted by 120 sponsor organizations. They evaluated subject enrollment per site, eCRF auto-query rate, Subject visit to eCRF entry cycle time and data management query opened-to- answered cycle time as metrics. While they expected to indications of lower quality and lower patient enrollment, their analysis showed that sites in emerging regions are actually trending more favorably than those in established regions.
In this analysis, 8 regions were evaluated, North America, Western Europe, Eastern Europe, Eastern Europe, Pacific Asia, South America, Central America, Middle East and Africa where North America andWestern Europewere considered as established regions and the remaining 6 other regions as emerging regions.
eCRF auto-query rate is an important indicator of eCRF data quality, and in this analysis the rate for auto query was lower in Africa than established regions while the Middle East was closer to the established regions, when it came to average cycle time from subject visit to eCRF entry at site level, Africa and Pacific Asia out performed established regions. And data management query opened-to-answered cycle time was better in Africa than established regions and Middle East thanWestern Europerespectively. The source of these results are from the Medidata Insight™ metric warehouse.
As a conclusion, enrollment in emerging regions enroll overall more patients than established regions, this may be due at this time to reduced number of trials within these regions. The quality of data in these emerging regions tend to have less at least not more difficulty with reliable eCRF data capture than established regions and finally these sites tend to me more timely with data capture and cleaning than established regions.
This article reinforces the potential of emerging regions, and MENA should not be ignored as a region for patient recruitment while ensuring quality data.
*: Is Risk-Based Monitoring an Appropriate Methodology for Clinical Trials in Emerging Regions? An Analysis of Clinical Site Performance Across Global Geographic Regions (page 26 -28).
ARIANNE Corp (www.ariannecorp.com) conducts clinical trials in emerging economies including MENA and S. Africa. Our local staff is fluent in the native languages, Arabic and French plus English. ARIANNE has a strong international regulatory understanding, and a corporate commitment to develop long-term relationships with a strong team approach to assist your global needs.