MHRA shares CluePoints case study to demonstrate the value of statistical monitoring in clinical trial oversight and monitoring
King of Prussia, PA – 7th March 2022: CluePoints, the premier provider of Risk-Based Study Execution (RBx) and Risk-Based Quality Management Software for clinical trials, has been cited in the updated Good Clinical Practice (GCP) guidance from the UK’s MHRA, putting the agency´s considerable weight behind CluePoints’ industry-leading statistical monitoring solutions.
The document, Oversight and Monitoring Activities, covers a broad range of clinical trial activities, including the use of committees to manage trials or review emerging safety data, the central review of clinical trial data, data management processes, and pharmacovigilance signal detection.
It also outlines the benefits of statistical monitoring, an aspect of centralized monitoring in which statistical approaches or modeling examine clinical or performance data as it accumulates. This allows for site-to-site comparisons of data points, with the aim of flagging risk signals like unusual patterns, variances, or distributions, for further investigation. It is an approach that can quickly and accurately reveal issues that on-site monitoring can easily miss, such as equipment malfunction, training needs, protocol misinterpretation, rater variability, and even fraud.
To demonstrate the value of the method, the MHRA has reviewed and shared a case study of the CluePoints SMARTTM engine. “It is a statistical software solution that examines if data collected are consistent, and if not, pinpoints those investigator sites that differ substantially from the others involved in a trial. In this regard, it is powerful in detecting outlying sites,” says the guidance.
The shared case study focuses on a phase II vaccine trial of 16,000 patients across 200 investigator sites in the North American, European, and Asian Pacific regions.
To gain a comprehensive evaluation of data quality and ensure any necessary corrective action could be taken early, the sponsor deployed CluePoints’ SMART engine. The statistical monitoring solution scheduled analyses every six months during the four-year study, comparing multiple data points across the sites.
It found several sites in one country (Country X) had recorded significantly lower mean body temperature measurements than those in other nations. This prompted an investigation that found all sites in Country X had received miscalibrated thermometers.
The error magnitude was too small to be detected using traditional on-site monitoring but was revealed instantly using statistical analysis methods. As such, investigators were able to take swift, corrective action, replacing all defective thermometers before the issue could impact data quality or integrity.
Patrick Hughes, Co-Founder & CCO at CluePoints, commented: “Centralized Statistical Monitoring, for which CluePoints has become famous, has the potential to expedite drug development pathways and protect patient safety, yet sponsors and CROs have often lacked practical guidance on using the method to gain these significant and long-needed benefits.
The updated MHRA guidance is a huge step forward for modern trial design. We are incredibly proud to be the only statistical monitoring technology provider included in the document. We feel it truly demonstrates the power of our solutions and the ongoing commitment we have to improve traditional and ineffective processes using practical and robust technology solutions. Alongside the Cooperative Research and Development Agreement (CRADA) that CluePoints has with FDA to support their focused site inspection, this represents an important regulatory message in support of fit-for-purpose technology that enables process improvement that is long overdue.
As we move further into the era of digitalized clinical trials, we are keen to continue sharing our knowledge and innovation with the broader scientific community. Because better clinical trials mean faster access to efficacious, life-changing drugs for the people we, as an industry, all serve.”
For further information on CluePoints’ solutions and further case studies, please visit www.cluepoints.com
CluePoints is the premier provider of Risk-Based Study Execution (RBx) and Data Quality Oversight software. Our products utilize comprehensive statistical algorithms to determine clinical trial data quality, accuracy, and integrity, both during and after study conduct. Aligned with guidance from the FDA, EMA, and ICH E6 (R2), CluePoints® is deployed to support central and on-site monitoring, medical review, quality risk management, and drive a holistic risk-based strategy in all trials. Coupled with thought leadership and consulting expertise to aid pre-study risk assessment, identification of risk controls, and solution implementation, you now have everything you need to adhere to global regulatory guidance. The result is increased operational efficiency, lower costs, and reduced regulatory submission risk as part of the industry paradigm shift to RBx.