Cytel Inc., recently unveiled Compass, an industrial strength software package for adaptive dose-finding studies based on frequentist or Bayesian methods.
The FDA's recently issued adaptive trial guidelines draft encourages adaptive design use, especially in attempts to identify the optimal dose level.
Cytel has been at the forefront of applying adaptive trials in clinical practice for several years. Compass® has been developed from this experience and knowledge gained by East®, the extensively used adaptive and group sequential software for registration studies. Compass® now extends Cytel's adaptive design software line to include phase 2 dose-finding clinical trials.
Designers of dose ranging studies are challenged to find the correct dose(s) to carry into confirmatory development. The PhRMA Adaptive Dose Response Group has shown that adaptive methods often substantially improve on traditional designs at this crucial best dose determination stage.
Wider use of adaptive trials at this stage was previously inhibited by the lack of validated commercial software. Sponsor statisticians and their regulatory counterparts could only attempt to write their own statistical design code.
The advent of Compass® provides study planners with a workflow for modern dose identification study construction using accepted adaptive methods. The built-in high-speed simulation engine quantifies design option decision-making, while visualizations of the trial characteristics improve understanding amongst both development teams and regulators, too.
A demonstration is replay-able at: http://www.cytel.com/News/Webinars.aspx
Driving Diversity with the Integrated Research Model
October 16th 2024Ashley Moultrie, CCRP, senior director, DEI & community engagement, Javara discusses current trends and challenges with achieving greater diversity in clinical trials, how integrated research organizations are bringing care directly to patients, and more.
AI in Clinical Trials: A Long, But Promising Road Ahead
May 29th 2024Stephen Pyke, chief clinical data and digital officer, Parexel, discusses how AI can be used in clinical trials to streamline operational processes, the importance of collaboration and data sharing in advancing the use of technology, and more.
The Rise of Predictive Engagement Tools in Clinical Trials
November 22nd 2024Patient attrition can be a significant barrier to the success of a randomized controlled trial (RCT). Today, with the help of AI-powered predictive engagement tools, clinical study managers are finding ways to proactively reduce attrition rates in RCTs, and increase the effectiveness of their trial. In this guide, we look at the role AI-powered patient engagement tools play in clinical research, from the problems they’re being used to solve to the areas and indications in which they’re being deployed.