The Cytel blog keeps you up to speed with the latest developments in biostatistics and clinical biometrics.

Empowering Statisticians to Create Complex Bayesian Clinical Study Designs

February 26, 2021

In the world of clinical trials, the pace of innovation is accelerating, and approaches such as Bayesian methods are gaining traction. These methods bring flexibility and speed to clinical trial design and analysis, and with increased access to the necessary computational power, are transforming today’s clinical research [1]. However, the number of simulation and modeling tools necessary to perform Bayesian computations requires statisticians to be well-resourced technologically. Many biostatisticians may not readily have access to the cloud computing power to make these design approaches practical within the time constraints afforded for statistical design.

There are many dose-finding designs that have been developed over the past 30 years and several more are anticipated [2]. Sponsors often face the dilemma of choosing from the various design options available today. Finding the right dose in Phase 2 gives a potential new therapy its best chance to demonstrate efficacy during Phase 3, and Bayesian techniques prove to be useful for optimal dose-finding.

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Bayesian Dose-Finding Designs – An Overview

October 27, 2020

 

Cytel recently conducted a webinar on Bayesian Dose-finding Designs for Modern Drug Development, presented by Dr. Yuan Ji.

Dr. Ji is a Professor of Biostatistics at The University of Chicago and a well-known name in the industry. In his presentation, he introduces representative Bayesian designs for dose-finding trials. The webinar offers insights on topics including classical DLT-based dose-finding designs, designs with delayed toxicity using time-to-event endpoints, and designs for combination dose-finding trial. Watch the on demand webinar to see the illustration of Bayesian modeling and inference for dose-finding designs that utilize the concept of probability intervals and related methods for clinical development and decision making.
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Yuan Ji on U-Design: An All New Efficacy and Toxicity Dose-Finding Module

October 23, 2020

Cytel’s New Horizons Webinar Series introduces you to the latest innovations in statistical trial design. This webinar from the series is presented by Dr. Yuan Ji, a consultant for Cytel. Yuan is the founder of Laiya Consulting and currently is the Professor of Biostatistics at The University of Chicago. In his presentation, Professor Ji introduces the U-Design version 1.4, which mainly consists of a new module of dose-finding trial designs with joint efficacy and toxicity outcomes.

Click the button to register for the next webinar in this series, presented by Cytel's Ursula Garczarek. Ursula will be presenting a case study on the value of detailed clinical trial simulations for rare diseases.

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TOGETHER trials, and the advantages of adaptive platform designs for investigating COVID-19 therapies

September 28, 2020

Cytel has recently designed and implemented the TOGETHER Trials, funded by the Bill & Melinda Gates Foundation to generate knowledge to help fight COVID-19, particularly in low and middle-income countries. The trials, with sites in Brazil and South Africa, test three existing interventions as possible treatments for COVID-19 in high-risk adults who do not require hospitalization, compared to a placebo.

The TOGETHER trials use an adaptive platform design. This type of design is particularly useful for contexts such as COVID-19 response, where there are many unknowns and a need for accelerated and resource-efficient answers, for 5 reasons.

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East Alloy: Accelerating the pace of innovation

September 17, 2020

Keeping up with the rapid pace of clinical development means that we need to adopt the innovative or computationally intensive designs like Bayesian methods. Yet, cutting edge technology can sometimes be difficult to assess or can introduce risk. Cytel’s new web-native extension of East, East AlloyTM, makes it practical and sustainable to adopt innovative and computationally intensive designs. Continue reading this blog to learn more.

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Adopt innovative and computationally intensive designs with East Alloy

August 31, 2020

Pantelis Vlachos, Principal, Strategic Consultant at Cytel, conducted a webinar to introduce the capabilities of East AlloyTM. East Alloy is a new East environment that enables rapid access to innovation with the trust and support you have come to expect from Cytel. The cloud-native software makes it practical to apply computationally intensive Bayesian methods. Download the brochure to learn more.

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This blog is a part of the new blog series on technology and Bayesian decision-making by Pantelis. Continue reading to learn about the methods and capabilities, such as, Bayesian meta-analytic priors, Bayesian MAMS, adaptive dose-finding and others, available to all East Alloy users. 

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Webinar on Adaptive Designs for Dose Finding: Part 2

August 19, 2020

Bjoern Bornkamp, Statistical Methodologist at Novartis and Jose Pinheiro, Senior Director, Johnson & Johnson provided their insights on adaptive designs for dose finding in Cytel’s latest webinar. The webinar demonstrates how adaptive and Bayesian techniques can be implemented for optimal dose-finding.

This two-part blog series provides a summary of the webinar. Read the first part to get key highlights from the presentation by Jose Pinheiro on the need to conduct dose finding Phase 2 studies, dose selection comparisons and the use of MCP-Mod for dose finding. 

Continue reading this second part to learn about the methods of adaptive dose-finding, presented by Bjoern. Click the button to access the webinar recording and download the presentation slides

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Webinar: Adaptive Designs for Dose Finding

August 13, 2020

Bjoern Bornkamp, Statistical Methodologist at Novartis and Jose Pinheiro, Senior Director, Johnson & Johnson provided their insights on adaptive designs for dose finding in Cytel’s latest webinar. Finding the right dose in Phase 2 gives a potential new therapy its best chance to demonstrate efficacy during Phase 3. A well-executed dose-ranging trial therefore has the potential to alter the course of the entire clinical development program. This webinar demonstrates how adaptive and Bayesian techniques can be implemented for optimal dose-finding.

This two-part blog series will provide a summary of the webinar. In this first part, get key highlights from the presentation by Jose Pinheiro on the need to conduct dose finding Phase 2 studies, dose selection comparisons and the use of MCP-Mod for dose finding. Click the button to access the webinar recording and download the presentation slides

Access Replay

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Access Sustainable, Verified Innovation with East Alloy

July 22, 2020

Cytel brings to you a new blog series on technology and Bayesian decision-making by Pantelis Vlachos, Principal/Strategic Consultant for Cytel. In his inaugural post Pantelis walks us through the features and benefits of our new offering, East Alloy™. East Alloy™ is a web-based extension of East for clinical trial design that blends the pace of SaaS delivery, the ease of use and robustness of Cytel software, and the velocity of cloud-based computing. 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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