CluePoints Statistical Monitoring Used to Check Data Quality in Large Phase III Gastric Cancer Trial

CluePoints, a provider of Centralized Statistical Monitoring (CSM) solutions for clinical trials, 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 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 analysis of the study data by CluePoints found no atypical data patterns that might have negatively affected the confidence in the study results.

Read the full release here.