CluePoints, a leading provider of Centralized Statistical Monitoring (CSM) solutions for clinical trials and partner of the Partnerships in Clinical Trials Event, has announced that its CSM platform has been used to assess the quality and integrity of data in a Phase III study of gastric cancer. The Stomach Cancer Adjuvant Multi-Institutional Group Trial (SAMIT), sponsored by the Epidemiological and Clinical Research Information Network (ECRIN) at Nagoya University School of Medicine, Nagoya, Japan, implemented the solution to check the quality of the data collated during the eight year study of 1,495 patients across 230 hospitals in Japan. The SAMIT trial is the largest ever adjuvant trial for gastric cancer.
The randomized study was conducted to elucidate the survival benefit of sequential use of paclitaxel followed by oral fluoropyrimidines in comparison with fluoropyrimidines alone, and to compare the two most commonly used oral fluoropyrimidines, UFT and S-1. The CluePoints solution enabled the investigators to check data quality across all clinical subjects in the various hospitals involved in the trial to confirm data consistency and document where any anomalies may have occurred. The information was collected and quality checked centrally at the ECRIN Data Center in Nagoya. The study findings, recently published by Lancet Oncology, show that the exhaustive analysis of the study data by CluePoints found no atypical data patterns that might have negatively affected the confidence in the study results.
"We are delighted that our CSM solution has been successfully used by the Nagoya University School of Medicine to assess the integrity of data collected in this important study", comments Franҫois Torche, CEO of CluePoints. He continues, "CluePoints' platform offers a powerful and sophisticated way of looking at the totality of data to detect anomalies. This not only helps to improve clinical data quality and contributes a significant reduction in overall submission risk, it also offers sponsors the opportunity to target their monitoring towards sites where it is most necessary.”
Professor Junichi Sakamoto, MD, PhD, Director at Tokai Central Hospital, said, "We wanted to perform an independent analysis of the quality of the data collected in the SAMIT trial prior to publication of the results in a major clinical journal. CluePoints provided us with an exhaustive and thorough review of all the data collected, and convinced us of the reliability of the findings across the investigational centers involved in the trial."
Driven by the company's sophisticated patent-pending SMART™ engine and aligned with current FDA and EMA recommendations, CluePoints' approach enables trial sponsors to identify signals in study datasets so that corrective actions are taken early and sites re-assessed periodically throughout the course of the study. This ensures the quality and integrity of the clinical data at substantially lower costs than more conventional on-site monitoring models that use extensive source data verification.
A full paper on the SAMIT study has been published in The Lancet.
For further information on CluePoints' solutions, please visit www.CluePoints.com
*The SAMIT trial is registered at UMIN Clinical Trials Registry, number C000000082.
CluePoints® is a Central Statistical Monitoring solution that has been designed and perfected over the last 10 years. It employs unique statistical algorithms to determine the quality, accuracy and integrity of clinical trial data both during and after study conduct. Aligned with guidance from the FDA and EMA, CluePoints® is deployed to support traditional on-site monitoring and to drive a risk-based monitoring strategy. The value of using CluePoints® lies in its powerful and timely ability to identify anomalous data and site errors allowing improvement in clinical data quality, optimization of on-site monitoring and a significant reduction in overall regulatory submission risk.
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