I finally got around to finishing a white paper on ACES. ACES is a secure, web-based platform, developed as a software-as-a-service (SaaS) model by Cytel, to help clinical teams implement fixed and adaptive trial designs that use interim analyses. The unique feature set of ACES enables it to be extremely useful and effective in facilitating the administrative and operational tasks required when performing interim analyses. ACES was designed to address the concerns of regulatory agencies that are present when conducting unblinded interim analyses.
You can download the full white paper here.
In the past decade, there has been a significant increase in the use of Data Monitoring Committees (DMC) and Adaptive Designs (AD) in clinical trials. While the monitoring of safety data by a formal committee is not required for all clinical trials, it has become the norm to have a formal DMC conduct periodic safety reviews for any controlled trial that evaluates treatments intended to prolong life or reduce risk of major adverse health outcomes, or for trials that compare rates of mortality or major morbidity. Confirmatory, pivotal, and adaptive design trials have more complex operational issues requiring an external and independent DMC. The DMC may have access to unblinded interim data, be required to make expert recommendations about how the trial should continue, and then ensure that planned adaptations are implemented as outlined in the protocol without involving the sponsor or exposing it to unblinded data or results.
This added complexity creates a challenge and a question: how can the DMC, statisticians, and sponsor effectively communicate, share blinded and unblinded data, perform analyses, and implement adaptations without introducing operational bias or compromising the integrity of the trial? One solution is to utilize a sophisticated computer system that can provide the security and necessary firewalls to ensure that interim data is only accessible to those it is intended for, that the rules and processes outlined in the protocol and DMC charter are enforced, and that communication between the DMC and sponsor is effectively facilitated while protecting the integrity of the trial and preventing the introduction of operational bias.
The system must also provide an audit trail that tracks “who saw what and when” providing evidence to regulatory authorities that the protocol was strictly followed with a minimal possibility of bias. This white paper describes the computer system, ACES, which Cytel has built, that makes all of this possible. ACES (Access Control Execution System) has been purpose-built to address the operational complexities inherent in adaptive design and pivotal clinical trials.