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

Webinar: Practical Model-based Approaches for Phase I Oncology Trials

June 24, 2020

Last week, Cytel conducted its third webinar in the new introductory webinar series on Complex Innovative Trial Designs. Our speaker, Dr. Satrajit Roychoudhury is a Senior Director, Statistical Research and Data Science Center at Pfizer. In this webinar, Dr. Roychoudhury gets into the basics of phase I designs in oncology trials, explains the caveats of frequently used traditional designs and provides insights on how implementing a model-based approach can enable a better statistical inference and decision-making. You can watch the replay of the webinar and access the slides by clicking on the button.

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We also had the privilege to interview Dr. Satrajit Roychoudhury. Read our blog where he talks about his interest in statistics, explains the concept of Bayesian model-based approaches and their importance in oncology trials.

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Significance of Bayesian Model-Based Approaches in Oncology Trials: An Interview with Dr. Satrajit Roychoudhury

June 15, 2020

On June 17, 2020, Cytel is conducting a webinar with Dr. Satrajit Roychoudhury, Senior Director, Statistical Research and Data Science Center, Pfizer. Dr. Roychoudhury will be talking about practical model-based approaches for phase I oncology trials. This webinar is a part of Cytel’s “Introduction to Complex Innovative Trial Designs” webinar series. You can register by clicking on the button below.

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In this blog, we bring to you an insightful interview with Dr. Satrajit Roychoudhury where he talks to us about his interest in statistics, explains the concept of Bayesian model-based approaches and their importance in oncology trials.

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Webinar: Group Sequential Designs and Sample Size Re-estimation

June 10, 2020

Cytel is conducting a webinar series that introduces biostatisticians to some of the more commonly used complex innovative trial designs. Our second webinar from this series was held on June 3, 2020, with Professor Christopher Jennison. Professor Jennison spoke about the modern uses of Group Sequential Designs and Sample Size Re-estimation. Group Sequential Designs were one of the earliest deviations from a traditional two-arm clinical trial with no interim looks at the data. They still add amazing value to trials through their abilities to safeguard patients, reach positive conclusions early and keep trial designs simple and streamlined. Sample Size Re-estimation is another key tool in the modern trial designer’s toolkit.

Cytel also did an interview with Professor Jennison where he spoke to us about these methods, their origin and how they add value to the industry. Continue reading this blog for a summary of the webinar. Click on the button below to access the webinar replay and download the presentation slides.

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Webinar: Innovative Drug Development at a Glance

June 1, 2020

In a recent interview with Cytel, Zoran Antonijevic, longstanding chair and leader of the DIA Adaptive Design Scientific Working Group, spoke about adaptive design methods. He gave us insights on how these methods can help achieve new levels of clinical trial efficiency and probability of success.

Cytel is conducting a webinar series that introduces biostatisticians to some of the more commonly used complex innovative trial designs. On May 20, 2020, Zoran Antonijevic joined us as a speaker at a webinar from this series, “Innovative Drug Development at a Glance - The Concepts, The Vision, & The Factors to Consider”. In the webinar, Zoran defines complex innovative trial designs, summarizes the potential benefits of each, and highlights key factors to consider when applying these techniques. Continue reading this blog for a summary of the webinar. Click the button to get free access to the webinar slides and recording.

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Interview with Professor Christopher Jennison: Group Sequential Designs and Sample Size Re-estimation

May 27, 2020

In this blog, we speak with Christopher Jennison, Professor of Statistics at the University of Bath, UK. Professor Jennison provides us insights on group sequential methods, the origin of their implementation and the value they have been adding over the years.

Cytel is hosting a new webinar series that introduces clinical fellows, early career biostatisticians, and others interested in clinical research, to some of the more commonly used complex innovative trial designs. In our previous blog, we spoke with Zoran Antonijevic about adaptive design methods.

Join us for a complimentary webinar on June 3, 2020 where Professor Jennison is going to introduce us to the basics of group sequential designs and sample size re-estimation. Learn how to use these methods and understand how they can improve trial design.

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Interview with Zoran Antonijevic on Adaptive Design Methods

May 18, 2020

In this blog, we speak with Zoran Antonijevic, longstanding chair and leader of the DIA Adaptive Design Scientific Working Group, and former Principal Statistical Consultant at Cytel. We speak about adaptive design methods, their value to the industry, their success and ways to overcome the existing challenges including the hesitation towards its wide adoption.

This summer Cytel is hosting a new webinar series that introduces clinical fellows, early career biostatisticians, and others interested in clinical research, to some of the more commonly used complex innovative trial designs. These webinars will cover the benefits of each design, and the practical considerations for adoption.

On May 20, 2020 Zoran Antonijevic is going to present an introductory overview of all these advanced design methods, in a webinar from this series. This webinar will define complex innovative trial design, briefly introduce the concepts, summarize the potential benefits of each, and highlight key factors to consider when applying these techniques. You can register by clicking on the button below.

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Highlights from the 2020 Virtual CDISC EU Interchange by Angelo Tinazzi - Part 2

April 27, 2020

In the first part of this two-parts blog, I speak about how the European CDISC Committee (E3C) together with CDISC converted our physical event into a virtual one and was held on April 1-2, 2020. I provided a summary of the updates received from the three main health authorities - the US FDA, the Japanese PMDA and the European EMA.

This post offers an overview of the other sessions I attended at the 2020 Virtual CDISC EU Interchange. The agenda was well planned and organized. The distinguished speakers were extremely prepared and answered numerous questions after their presentations. Continue reading for further highlights from the event.

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Highlights from the 2020 Virtual CDISC EU Interchange by Angelo Tinazzi

April 24, 2020

In early March, when countries around the world started implementing lockdowns, the European CDISC Committee (E3C) together with CDISC decided to cancel our physical event in Berlin, planned for April 1-2, 2020. It was a tough decision, but unavoidable and necessary.

We did not let this dampen our spirits and immediately came up with an alternative plan – go virtual with the event! In only two weeks the team managed to pull together a revised program and the registrations were opened on the CDISC website. The scale of the event went from being Europe-only to Global, and around 300 people attended it worldwide. In the end, the event was a hit. Everything worked out very well, with no major technical disruptions and the speakers respecting the allocated time slots.

In this two-part blog post, I share a summary of the sessions I was able to attend, while simultaneously ensuring business continuity for my regular projects.

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Managing risk in clinical development: Is your data strategy fail-safe?

March 5, 2020

Generating high-quality clinical data is a vital but challenging task in modern drug development. Unfortunately, in the current era of ‘big data’ and global clinical operations, spanning multiple sites and digital systems, protecting the quality of clinical data has become harder than ever.

Planning your data strategy is, therefore, crucial to ensure a high-quality evidence package and increase the chances of successful clinical development. However, as we discuss in our new eBook, planning a data strategy is a complex process involving various considerations that require significant amounts of time and expertise to fully address.

Read our eBook for expert insights on planning a data strategy that can help overcome key challenges in clinical development and boost your success.

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In this blog, we discuss the many data-related challenges commonly faced in clinical development and how to implement a fail-safe data strategy that can overcome these challenges, bringing effective new therapies to patients.

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