“In response to our client’s needs, we have updated our IRT platform to be more efficient by utilizing a modular system architecture with reusable functionality,” Dr. Malcolm Burgess, Executive VP, Interactive Technologies, ICON, told Outsourcing-Pharma.com.
The new platform offers enhanced randomization and clinical supply management capabilities to support adaptive trial execution – a practice which, according to Tufts, can save companies millions each year.
“These changes allow for faster implementation coupled with increased quality,” added Burgess.
“The updates were completed in order to upgrade our technology base and to give us a database structure that would allow us to seamlessly integrate with other technologies in the clinical supply ecosystem. This includes linkages to statistical applications to enable adaptive trial support.”
Adaptive trial designs
The main benefit of the new platform is its flexible randomization engine that can be adjusted mid study. For example, treatment arms can be added or removed as appropriate after an interim analysis.
According to Burgess, this enables adaptive clinical studies while protecting the blind and maintaining data integrity, which has been a major concern for adaptive trial adoption in the past.
“Unblinded statisticians can log in and review or even download patient data, the interface then allows them to adjust the randomization design if appropriate,” he added.
Additionally, the company has developed what it calls the Adaptive Execution Environment, which allows execution of interim and final analyses in a controlled environment with full action traceability.
“All programs needed for an interim analysis are prepared by statisticians or statistical programmers in advance and can be invoked via the web interface of the Adaptive Execution Environment as appropriate during the course of the trial,” explained Burgess.
This allows users to review results, log files, and audit information of all interim analyses at any time. It also eliminates manual data hand-overs for data consistency and reduces the time needed for the analysis.
Analysis results are then available to authorized team members either for on-line review or download before a decision is made and the changes implemented via the Adaptive Execution Environment.