The guidance advocates the use of central monitoring to ensure the quality of clinical trial data and cites two papers written by the architects of CluePoints’ intelligent statistical algorithms that describe how these techniques can be used to effectively detect anomalies, and help improve the effectiveness of on-site monitoring by prioritizing site visits using central statistical data checks.1
The new FDA guidance describes how central monitoring methodologies should be used, where appropriate, to oversee studies and effectively monitor clinical investigations to protect subjects and enhance the quality of research. The FDA also states that the previously preferred approach for regular on-site monitoring with 100% Source Data Verification (SDV) is no longer called for, particularly due to new technological advances that make it possible to monitor data quality more efficiently.
Not only do the CSM techniques offered by CluePoints play a crucial role in Risk-Based Monitoring, but they are used even more generally as part of a sponsor’s risk-mitigation strategy as they are extremely efficient at identifying data anomalies and, consequently, enhancing the quality of the final submission. Larger pharma sponsors are taking the clinical oversight advantage a stage further and are using CluePoints to ensure that their strategic outsourcing programs are not just getting them to database lock on-time and on budget, they are also safe in the knowledge that the quality and integrity of their clinical data is beyond reproach. They are running regular analyses of the clinical data throughout the study and charging their partners with taking corrective actions as discrepancies are identified.
The resulting efficiencies from undertaking CSM to target the sites identified ‘at risk’ are now being successfully harnessed by many sponsors and CROs alike. The savings that sponsors will enjoy from a comprehensive Central Monitoring approach will no doubt be significant in the medium-term, but even today sponsors can experience tangible cost benefits by reducing on-site monitoring efforts through targeting those sites that are deemed to be outliers using advanced statistical techniques to analyze the clinical trial data.
Marc Buyse, Founder of CluePoints commented, “This is a major step forward for our industry and one that all sponsors should embrace. The opportunity to improve data quality and integrity, while mitigating risk, is the outcome that everyone wants and the agency is encouraging an approach that not only does this but offers companies the opportunity to increase efficiencies and, ultimately, save a lot of money. CluePoints is delighted to be at the forefront of this initiative and is available to consult with anyone who is interested in the practical application of these techniques based on proven and validated experience to date”.
Francois Torche, CEO, CluePoints, says, “The agency’s guidance is recognition of an approach that the CluePoints team has been working towards for a number of years. We have a talented and enthusiastic group of experts that have been assisting sponsors to implement various approaches to Risk-Based Monitoring and the final guidance is a very close match to our overall vision. Subjective Key Risk Indicators based on operational metrics are of value but there is no doubt that an objective assessment of data quality is crucial to managing regulatory risk and ultimately reducing costs”.
Please see below for copies of the papers on Central Statistical Monitoring that are referenced in the FDA Guidance for Industry “Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring” for the guidance itself.