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

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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Need for Technology Solutions to Support Computationally Intensive Bayesian Designs

October 26, 2020

Pharmaceutical and biotech companies are under pressure to deliver more and deliver faster with fewer resources. The cost of drug development, failure rate and human cost associated with prolonged participation in a trial turn out to be steep in case of an ineffective trial. 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.

Bayesian methods are of growing interest to the drug development industry, as they allow clinical investigators to leverage historical trial data as well as learnings from new data as it accrues throughout a trial. The result is better-informed decision making, greater program flexibility, and the ability to run smaller, more resource-efficient trials.

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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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An Interview with Bart Heeg (Part 2): New Trends in HEOR

October 22, 2020

In this two-part blog series, we interview Bart Heeg, Vice President HEOR and Founder at Ingress Health (A Cytel company). Bart provides us insights on the trends in HEOR and explains why Bayesian methods are also important for Health Economics. Read Part 1 here.

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Cytel Introduces Advanced Design Framework: Part 1 - Methods for Thorough Exploration of Design Space

October 21, 2020

Cytel has recently revealed its Advanced Design Framework, a method developed by Cytel’s thought-leaders after a decade of fine-tuning clinical development processes. The framework consists of three parts: Thoroughly Explore, Decide Together, and Communicate Trade-Offs.

The Framework demonstrates how to unify statistics and strategy in the era of cloud-computing, by making strategic use of well-resourced statisticians. This week, we take a deeper look into the first part of this Framework, revealing 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

October 15, 2020

For over a decade, advanced trial design techniques have promised efficient trials with accelerated timelines, reflecting the ability to quantify uncertainty and de-risk trials using adaptive tools. Despite the emergence of these complex innovative designs, the success of Phase 3 trials has continued to hover at 33% while the average time to market remains about 6 years.

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Bayesian Statistics and FDA Regulatory Acceptability

October 12, 2020

 

Cytel and Novartis are together hosting a complimentary Bayesian Virtual Symposium and an Interactive 7-part workshop. This series will expose you to cutting edge topics from industry renowned leaders in Bayesian statistics. The introductory webinar “Bayesian Statistics and FDA Regulatory Acceptability” is presented by Greg Campbell, PhD, Former Director of Biostatistics, U.S. Food and Drug Administration.

In the United States Bayesian statistics has been used in regulatory submissions to the Food and Drug Administration (FDA) for confirmatory clinical trials medical devices for more than fifteen years. In this webinar, Dr. Campbell reviews the Bayesian history and accomplishments for medical devices. He talks about the status and opportunities of Bayesian statistics for pharmaceutical drugs and biologicals. We also learn about the challenges and the future of Bayesian statistics in the regulatory environment. You can access the on demand webinar and register for the rest of the series by clicking the button.

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The Meta-Analytic-Predictive Priors Generation and Comparisons

October 5, 2020

Staying abreast of the rapid pace of clinical development means adopting innovative or computationally intensive designs like Bayesian methods. These methods allow for the incorporation of prior knowledge, in terms of either expert opinion from clinicians or historical data, in statistical inference. Thus, they have the additional advantage of being able to work with real-world data (generally, real-world data has a lot of missing data) without the need to impute missing values. These kinds of models are also flexible enough to work with temporal data. This helps ease the reliance on large sample approximations that are often required for frequentist methods and generally results in greater efficiency in study design.

In this edition of The Informative Bayesian by Pantelis Vlachos, we learn about information borrowing to form a prior distribution. In a Bayesian framework, borrowing from historical data is equivalent to considering informative priors. These priors can be derived as meta-analytic predictive (MAP) priors or using patient-level data.

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Innovations in Bayesian Trials: A Virtual Event Brought to you by Cytel and Novartis

September 30, 2020

 

Today, there is a need for advanced quantitative techniques to combine all available information for better decision making in health care. Bayesian statistics allow us to make probabilistic inferences on the parameter of interest, which is missing in a traditional frequentist approach. Apart from the philosophical issues, Bayesian analysis provides a practical and intuitive tool for interpretation of study results and risk evaluation of clinical hypotheses.

Cytel and Novartis are together hosting a complimentary Bayesian Virtual Symposium and an Interactive 7-part workshop. This series will expose you to cutting edge topics from industry renowned leaders in Bayesian statistics. Click the button to learn more and register.

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