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

2020 Recap by Yannis Jemiai, Chief Scientific Officer, Cytel

December 17, 2020

As Chief Scientific Officer, Dr. Yannis Jemiai plays a pivotal role in maintaining Cytel’s well-established reputation for statistical excellence and our track-record of bringing innovative analytic approaches to the development of medicines for human health. In this blog, we ask Yannis for his favorite Cytel events from 2020.

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2020 Recap by Pantelis Vlachos, Principal/Strategic Consultant, Cytel

December 16, 2020

As we prepare to close the door on 2020, we asked Pantelis Vlachos, Principal/Strategic Consultant for Cytel, to share his favorite Cytel events of this year. Continue reading this blog for a summary of Cytel’s 2020 contributions around adaptive designs and Bayesian methods.

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Satisficing, Optimizing and Globally Optimizing Trial Designs

December 15, 2020

When designing clinical trials, biostatisticians and clinical development teams are often faced with a conundrum. Given the parameters of their clinical study, they usually begin with five or six possible design options and begin to explore the most promising ones. The likelihood is that none of these trials will be optimal designs. Rather, they meet certain criteria that are “good enough” at which point, clinical development teams might begin to lead one way or another.

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Reimagining Clinical-Trials - Strategic Clinical Trial Design: 7 Key Features

December 9, 2020

 

As a part of Cytel’s Advanced Design Framework, a new Framework for the statistical design of clinical trials, Cytel discovered that a specific combination of process changes and technological advances has the potential to increase clinical development productivity by 10-20%. The Framework summarizes these as Thoroughly Explore, Decide Together and Communicate Tradeoffs. Here are 7 key features of this improved strategic framework. Alternatively, watch the webinar of our Chief Scientific Officer Yannis Jemiai discussing this Advanced Design Framework. 

Watch On Demand

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New Whitepaper: Reimagining Clinical-Trials

December 3, 2020

Increasing Clinical Development Productivity Using Statistics and Cloud-Computing

The need for Re-imagining Clinical Trials: A recent survey conducted by Cytel found that only 42% of respondents reported using any complex or innovative clinical trial designs beyond the familiar group sequential approach. Although regulators respond quite favorably to such designs, sponsors have remained hesitant to use them.

A combination of technological and process advances are necessary to overcome mechanisms that contribute to stagnating statistical innovation in clinical development. Cytel responded by creating this new whitepaper that provides a new strategic framework that can help Clinical Development teams leverage cloud-computing and begin to initiate process changes, necessary to increase development productivity by 10-20%.

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We can design over 100,000 clinical trials in less than an hour. How do we choose from them?

November 18, 2020

The current state of the clinical trials industry faces a challenge that was only hypothetical three or four years ago. Thanks to the advent of cloud-computing and advances in simulation technology, sponsors can now design hundreds of thousands of clinical trials in less than an hour. Yet how do we choose amongst all of these myriad options in a way that optimizes commercial prospects? Cytel’s Chief Scientific Officer sits down with us to discuss the Re-imagined Clinical Trial.

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Interview with Yannis Jemiai: Advanced Design Framework

November 11, 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

According to Yannis Jemiai, Chief Scientific Officer at Cytel, a combination of technology and process changes can establish the foundation for significant increases in productivity. Yannis argues that uncertainty should not be viewed as a challenge but an opportunity. Using statisticians strategically as well as tactically throughout the design process can help R&D teams drive commercial value for greater speed, savings and success.

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Cytel Introduces Advanced Design Framework: Part 3 - Communication Techniques to Ensure Alignment on Data-Driven Clinical Trial Designs

November 4, 2020

Cytel has recently revealed its Advanced Design Framework, a method developed by Cytel’s thought leaders that draws on decades of experience increasing clinical development productivity. The Framework illustrates how advances in design processes and technology can help development teams deliver greater business results, unifying statistics and strategy in the era of cloud computing and making strategic use of well-resourced statisticians.

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Cytel Introduces Advanced Design Framework: Part 2- The Need for A Quantitative Evaluation Approach for Deciding Together

October 29, 2020

Cytel has recently revealed its Advanced Design Framework, a method developed by Cytel’s thought leaders that draws on decades of experience increasing clinical development productivity. The Framework illustrates how advances in design processes and technology can help development teams deliver greater business results, unifying statistics and strategy in the era of cloud computing, and making strategic use of well-resourced statisticians.

The framework consists of three parts: Thoroughly Explore, Decide Together, and Communicate Trade-Offs. This week we take a deeper look into the second part of this Framework, revealing how to effectively incorporate varied perspectives to efficiently design innovative clinical trials. Opportunities for quantitative evaluation criteria and design without bias help R&D teams sift through the thousands of trial designs options to optimize for speed, success, and savings.

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