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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Interview with Thomas Wilke: Health Economics and Real-World Evidence Studies

October 20, 2020

In this interview with Thomas Wilke, Principal Scientist at Ingress-Health (a Cytel company), we talk to him about his background and experience in Health Economics, understand the important considerations of real-world evidence studies and the impact of COVID-19 pandemic on the work of the health economics outcomes researchers who work at Ingress and Cytel. We also cover important HEOR topics such as its benefits for market access studies and real-world analytics (RWA) for regulatory submission.

Cytel and Ingress-Health will be contributing to a range of events at Virtual ISPOR EU 2020, on November 16th – November 19th. Our Real-World analytics teams will be collaborating to deliver a number of interactive workshops, issue panels, posters and podiums to showcase their work and share innovative insights in HEOR, evidence generation, knowledge synthesis and decision analysis.

Click below to download our full list of sessions at ISPOR EU

download the  sessions schedule

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Upcoming Discussions: The Uniqueness of COVID-19 Real-World Data Challenges & The COVID-19 trial tracker

October 19, 2020

COVID-19 has created extreme uncertainties -- a dearth of historical information combined with the need for safety, statistical rigor, and speed has prompted the rapid surge in the generation of clinical data. However, this information is scattered across multiple platforms, making it challenging to measure comparative treatment effects across trials. Consequently, we are seeing a high frequency of failures, that diminishes the public’s confidence in research and slows the path from scientific results to action.

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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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An Interview with Bart Heeg (Part 1):The Increasing Importance of Health Economics

October 14, 2020

A credible evidence base is needed to support and document the economic value of new technologies and therapeutic approaches. Companies need careful cost-effectiveness analyses for successful reimbursement submissions. In this two-part blog series, we interview Bart Heeg, Vice President HEOR and Founder at Ingress Health (A Cytel company). Bart talks about his background in HEOR, founding Ingress Health and its recent acquisition by Cytel. He also talks about the benefits of turning to an HEOR specialist and provides a sneak peek into Cytel’s presentations at the upcoming ISPOR EU 2020 event.

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