Active in Europe, the United States and Asia, a company respectfully established in the fields of biostatistics, data management and central randomization, IDDI has created a new monitoring system responding to the importance and high recommendation of central statistical monitoring (CSM) and the need for their expertise in this type of monitoring.
A pioneer in the field of central statistical monitoring, IDDI, in collaboration with Belgian entities ULB (IRIDIA), GSK Biologicals and UCL (ISBA), is developing and validating a system for monitoring and the statistical control of data quality of clinical trials, primarily based on multiple statistical tests whose results can be exploited by data mining tools and artificial intelligence designed not only to detect anomalies in data due to errors, but also negligence and fraud.
The project known as SMART (Statistical Monitoring Applied to Research Trials), developed with the financial support of the Walloon Region, aims to provide statistical monitoring with an ability to detect the heterogeneity of data throughout investigational centers and to create a quality label for clinical trial data.
While detection of deliberate (fraud) or unintentional errors is a concern at the highest level of pharmaceutical and biotechnology companies, there is currently no integrated and automated system to monitor the quality of data based on statistical tests and techniques of artificial intelligence or data mining.
Currently, clinical trial sponsors are required to set up appropriate measures to monitor the conduct of the trial. The aim of monitoring is to ensure the patients’ well being, compliance with the approved protocol and regulatory requirements, as well as data accuracy and completeness. These classical monitoring approaches that rely on on-site visits are useful for some purposes, but extensive source data verification is extremely time consuming and may have only a limited impact on data quality. It is therefore not surprising that the current practice of performing intensive on-site monitoring is being put to question and that the future interests focus more on pragmatic, risk-based approaches that will improve the cost-effectiveness ratio without compromising the quality and integrity of clinical trials. The central statistical monitoring (CSM) system would optimize on-site monitoring and improve data quality, and therefore could provide a cost effective-way of meeting regulatory requirements for clinical trials.
The CSM software will systematically perform a large battery of statistical tests based on the values of all variables collected in a clinical trial. The methodology and software behind SMART is intended to meet the critical requirements of Sponsors on clinical trial data by reducing the risks of a submission to regulatory agencies (FDA, EMA) by providing a “quality label” on the final data of the clinical trials; and reduce the time to study analysis and the cost of clinical trials by optimizing on-site monitoring and labor-intensive data verification.
Not only is the development of this project an exciting endeavor for IDDI and it’s partners, but SMART could also play an important role in making Wallonia a territory of excellence in Clinical Research, bring added-value to all biopharmaceutical and Clinical Research Organizations in the region, as well as respond to environmental concerns linked to the environmental impact of clinical trials due to extensive travel.
Webinar on CSM: https://www1.gotomeeting.com/register/697411248 :
This webinar presented the underlying principles of a statistical approach to central monitoring. The speakers illustrated typical findings obtained with this approach in actual trials from different therapeutic areas. They also briefly discussed alternatives, such as the use of key‑risk indicators.
Clinical Trials Publication: http://ctj.sagepub.com/content/early/2012/06/08/1740774512447898 : READ THE ABSTRACT ‘A STATISTICAL APPROACH TO CENTRAL MONITORING OF DATA QUALITY IN CLINICAL TRIALS. Published in Clinical Trials on June 8th.
Marie-Laure Dyck – Junior Business Developer – IDDI – TEL. 010/62.15.41 – FAX 010/61.88.88
Damien Tremolet – CEO – IDDI – TEL. 010/62.15.55