Monthly Archives: September 2014

CluePoints Used to Checked Data Quality in Large Phase III Gastric Cancer Trial

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12-16-14

CluePoints selected by the Nagoya University School of Medicine to assess data quality and integrity

16 September 2014

Cambridge, MA – CluePoints, a leading provider of Centralized Statistical Monitoring (CSM) solutions for clinical trials, 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 8 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 www.thelancet.com

For further information on CluePoints’ solutions, please visit www.CluePoints.com

*The SAMIT trial is registered at UMIN Clinical Trials Registry, number C000000082.

About CluePoints
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.

Media contact
Patrick Hughes – Chief Commercial Officer, CluePoints
Patrick.Hughes@CluePoints.com
+44 (0) 7703 532 749

Want Full Control of Your Risk-Based Monitoring Analyses?

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CluePoints introduces a web-based Central Statistical Monitoring (CSM) SaaS solution

As you may have read on a few industry blogs, we recently launched a Software-as-a-Service (SaaS) solution that can be implemented as part of a sponsor’s Risk-Based Monitoring (RBM) strategy. The web-based Central Statistical Monitoring (CSM) SaaS offering enables customers to control the upload of clinical data for assessment, visualize the findings and interact with analyses to make the understanding of results, comprehension of signals and identification of issues as intuitive as possible. For the first time, sponsors are able to support their RBM efforts and drive their own analyses using in-house staff or by providing their contract research organization (CRO) access to CluePoints’ system.

This web portal aims to put the sponsor in control so that they can run the analysis, set-up the SMART™ engine, construct and manage data within the system, select appropriate statistical tests and perform the complete CSM process independently and objectively. Continuous improvements will be brought to the software to meet clients’ needs.

The Game Plan

Launched in June 2014, the upgrade of CluePoints’ CSM software to a full SaaS solution afforded clients with the ability to:
• Set-up the engine themselves
• Construct and manage data dictionaries (study specific or therapeutic specific variable mapping, transpositions and derivations) within the system
• Select the appropriate statistical tests and thus perform the complete analytics process

The next major release, planned for Q4 2014, will support closer to real-time assessments of data and provide clients with the ability to:
• Access a collection of new visualizations that will enrich the existing findings content
• Provide an action follow-up/ tracking system module that will allow users to document and track any action taken based on reported findings
• Export results into machine-readable format allowing clients to use them in external systems

Although we are enhancing our web application, we will continue to support clients through a traditional Service offering format as well. For clients who wish to utilize the SaaS solution, CluePoints provides on-call support as needed.

Click here to request additional information about our Web Application