Cytel Blog

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

Cytel is conducting a webinar series on complex innovative trial designs. Dr. Thomas Burnett, Senior Research Associate in Medical and Pharmaceutical Statistics at Lancaster University, joined us as the presenter in the latest webinar from this series. In this webinar, “Adaptive Enrichment Designs in Clinical Development”, Dr. Burnett provides us a brief introduction to population enrichment and explains where it fits in clinical trials. He offers his insights on the topics of hypothesis testing and decision making, which is a key component of adaptive designs. You can also learn about a real-world case study (TAPPAS Trial) where this approach was used. Continue reading this blog for highlights from the webinar.

Watch the webinar recording and download the slides by clicking the button.

Read an interview with Dr. Thomas Burnett on adaptive enrichment.

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.

Cytel is hosting a complimentary webinar series that introduces biostatisticians and other members of the development team to some of the more commonly used complex innovative trial designs, the benefits of each, and the practical considerations for adoption. You can access the replay of the completed webinars and register for the upcoming ones by clicking on the button.

In this blog, we interview Dr. Thomas Burnett who is a Senior Research Associate in Medical and Pharmaceutical Statistics at Lancaster University. His main research interests are Adaptive clinical trials and personalized medicine. In the upcoming Cytel webinar on July 15, Thomas will be presenting on the foundational elements of enrichment strategies and adaptive designs.

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.

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.

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.

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.

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.

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.

On May 7, Cytel and Certara conducted a virtual panel discussion on new opportunities and implications for the future of drug development in emerging economies. The speakers included highly acclaimed key opinion leaders and industry experts who spoke about new sources of research funding being channeled towards emerging economies and the need to understand its strategic priorities to properly assess future opportunities for growth.

Our first panelist, James Orbinski is a professor at York University's Dahdaleh Institute for Global Health Research. James is an experienced medical doctor, a humanitarian practitioner, a best-selling author and a leading scholar in global health. After extensive field experience with Médecins Sans Frontières / Doctors Without Borders (MSF), Dr. Orbinski was elected MSF’s international president from 1998 to 2001. He launched its Access to Essential Medicines Campaign in 1999, and in that same year accepted the Nobel Peace Prize awarded to MSF. Our moderator from Cytel, Principal Scientist, Edward Mills began the virtual panel discussion by asking James a series of pertinent questions on the issues around the current pandemic. Continue reading this post for the Q&A.

Get access to the virtual panel replay by clicking on the button below.