Company insight
companies choose the most promising design with greater certainty. One of the most exciting features of the East Horizon platform is its focus on adaptive trial designs, a cutting-edge methodology that allows clinical trials to adjust dynamically as data is collected. Adaptive trials are becoming increasingly popular because they offer the ability to make real-time decisions on whether to continue, modify, or terminate a trial based on interim data. Historically, the industry has been hesitant to implement adaptive trial designs due to their sophisticated statistical methods and the perceived challenges of implementing them in practice. “Cytel's mission is to promote the adoption of these advanced, cutting-edge methodologies in clinical trial design,” says Trimm. The platform enables quicker decision-making, allowing pharmaceutical companies to identify drugs that show promise early on and focus resources on them, while simultaneously halting development for those that don’t meet efficacy or safety standards. The benefits of adaptive trials are clear: accelerate drug development, improve patient outcomes, and provide more cost-effective solutions for pharmaceutical companies. The East Horizon platform’s adoption of adaptive trial designs is expected to play a pivotal role in accelerating the overall drug development timelines.
Open-source embrace: R programming integration As part of its commitment to flexibility and innovation, Cytel has embraced open- source tools, particularly R programming, to expand the East Horizon platform’s capabilities. R is a powerful statistical programming language that is widely used in the industry, and its integration into the East Horizon platform is a major advantage for users who want to customize their trial designs. The East Horizon platform users can augment its built-in statistical methods by writing their own R scripts, thanks to the platform’s R integration feature. “We don't want to limit our customers to the things that we’re prioritizing, so we provide the option to use R programming
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within the software by simply writing an R script,” explains Trimm. Cytel has made it easy for users to access a library of pre-built R script templates through a package called CyneRgy, enabling even non-programmers to quickly adapt the platform to their specific needs. Moreover, Cytel is taking it a step further by introducing an R coding assistant in December 2024. This tool will assist users in writing R code by responding to natural language prompts. This feature makes the power of R accessible to a broader audience, reducing the barriers to customization without requiring users to have advanced programming skills.
Looking ahead, Cytel plans to allow users to create de-novo custom trial designs using R, explains Trimm, without being limited to the predefined design options in the platform. This will further enhance the flexibility and power of the East Horizon platform, making it an indispensable software for the pharmaceutical industry.
Building trust through security and quality
Given the critical nature of clinical trial data, ensuring data integrity, security, and quality is paramount for Cytel in developing the East Horizon platform, explains Deshmukh. The platform is built on Microsoft Azure, a robust cloud infrastructure known for its high security standards. “Security is a combination of people, processes, and technology,” he continues. Cytel’s engineers undergo rigorous security training, including secure coding practices, static application security testing (SAST), and dynamic application and security testing (DAST). Additionally, Cytel’s development process adheres to strict quality controls. The company uses an agile, incremental approach to software development, with extensive unit testing, peer reviews, and automated testing to ensure that each version of the East Horizon platform meets the highest standards. To address the complexity of statistical algorithms involved in clinical trial design, Cytel also employs expert statisticians who conduct user acceptance testing, ensuring that the platform performs reliably and
accurately. “The quality of our products is very high and the rate of production incidents that we see recorded by our customers is among the lowest in the industry,” adds Deshmukh.
Revolutionising clinical trial design
The East Horizon platform is designed to meet the evolving needs of the pharmaceutical industry, aligning with current trends such as the increasing use of adaptive trial designs and the growing demand for open- source tools. Its flexibility, ease of use, and powerful simulation capabilities make it an attractive solution for pharmaceutical companies seeking to optimise their clinical trial processes. Looking to the future, Cytel is committed to continuously improving the East Horizon platform. The company has already outlined plans for two exciting upcoming modules: Predict and Decide. Predict will focus on interim monitoring analysis and event prediction, allowing clinical teams to make data-driven decisions about a trial’s progression before its completion. Decide will help teams make go/no-go decisions at the end of a trial, enabling informed decisions about whether to move forward to the next phase of development. “These are two very exciting developments that will be coming in the near future within the East Horizon platform,” adds Trimm. These new features will further extend the platform’s capabilities, making it an even more powerful tool for the design and management of clinical trials. Cytel's expectations for the East Horizon platform are high. It is expected to revolutionize clinical trial design by making advanced methodologies, like adaptive trial designs, more accessible to a broader audience. With the East Horizon platform, Cytel is setting the stage for a new era in pharmaceutical research and development. ● East Horizon™, and East®, are trademarks or registered trademarks of Cytel Inc. All rights reserved.
www.cytel.com Clinical Trials Insight /
www.worldpharmaceuticals.net
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