Featured Articles
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The Technology You Need For Bayesian Clinical Trial Design
1/7/2021
Gain some behind-the-scenes insights into the development of this new module and understand how your company can leverage East Alloy to conduct computationally intensive designs with ease, confidence, and speed.
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Regulatory Approval For Bayesian Clinical Trials
1/7/2021
Clinical trials designed using Bayesian statistics are gaining prominence due to challenges raised by coronavirus. Former FDA Director of Biostatistics, Gregory Campbell, discusses best practices for securing regulatory approval when submitting a trial that employs Bayesian clinical trial design.
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Need For Technology Solutions To Support Computationally Intensive Bayesian Designs
12/9/2020
As the industry seeks new levels of clinical trial efficiency and probability of success, more companies are looking to use advanced, innovative and computationally intensive designs like Bayesian methods. With East AlloyTM, a web-native extension of Cytel’s world-renowned East® software, users can sustainably adopt Bayesian designs to expedite clinical development and overcome uncertainty without compromising scientific rigor.
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Re-imagining Clinical Trials: Leveraging Statistics & Cloud-Computing To Increase Development Productivity
12/2/2020
While regulatory and operational barriers remain a cause for concern in the sphere of research and development, there is mounting evidence that regulators will accept well designed flexible studies that put patients first. There is even more evidence that clinical operations teams can rise to the challenge. There are a growing number of drug approvals, for example, which include adaptive designs for regulatory findings, even for pivotal studies. What Development teams now need in the age of cloud computing is a process that allows new technology to explore more designs strategically.
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Re-Imagining Clinical Trials In The Era Of Cloud Computing: A Conversation
11/2/2020
The widespread use of cloud-computing has altered the clinical trial design process. Whereas three or four years ago, it would take a statistician perhaps two or three days to design five clinical trial designs, a well-resourced statistician can now simulate and model well over 100,000 designs in less than 30 minutes. How does this affect the process of designing clinical trials?
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Advanced Design Framework Part 3 – Communication Techniques To Ensure Alignment On Data-Driven Clinical Trial Designs
11/2/2020
The stakes are high in pharmaceutical development, and selection of the statistical trial design often requires several layers of approval before a team has authorization to proceed. Unfortunately, incomplete information, misinformation or bias during these preliminary discussions can have long-term consequences. In this blog we explore how clear articulation of the chosen design’s benefits and drawbacks can help ensure data-driven decision-making that improves speed, success, and savings.
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Advanced Design Framework: Part 2 – The Need For A Quantitative Evaluation Approach For Deciding
11/2/2020
Has your organization ever completed the execution of a long, expensive Phase 3 clinical trial only to learn that the organization is unable to commercialize the therapy? This blog shares how to effectively incorporate varied perspectives to efficiently design innovative clinical trials.
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Advanced Design Framework: Part 1 – Methods For Thorough Exploration Of Design Space
11/2/2020
Time and design tool limitations have restricted the breadth of design exploration possible, so it has been necessary to carefully select the portion of the design space to examine for consideration. This blog reveals how to explore hundreds of thousands of designs available to sponsors, rapidly and in real-time, to improve the chances of identifying the design that optimizes for speed, success, and savings.
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An Advanced Design Framework For Clinical Development In The Era Of Cloud-Computing
11/2/2020
While the number of trial designs and types have gently expanded, finding the optimal trial design for a specific context remains an elusive goal. Cloud-computing has altered the process of trial design, by taking familiar techniques for simulation and modeling, and generating thousands of different trial designs.
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An Illustrative Guide To Clinical Trial Design In The Era Of Cloud-Computing
11/2/2020
The mere availability of complex innovative trial design methodologies cannot translate into higher success rates in regulatory submission or approval if the process that drug development teams use for statistical design remains unchanged. Advanced technology now enables leaders to actively facilitate process improvements. Cytel’s new Infographic demonstrates the combination of technology and design process advances required to unify statistics with commercial strategy.