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: 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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COVID-19 Response: New Opportunities & Implications for the Future of Drug Development in Emerging Economies – Q&A with James Orbinski on Global Health Policy

May 28, 2020

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.

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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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Webinar: Transparent Machine Learning in Oncology

April 29, 2020

In our previous blog, we spoke with Alind Gupta, who works as a Machine Learning Researcher at Cytel in Canada. The interview gives you a deep dive into black-box models and transparent machine learning, and how the latter is becoming more important in clinical research today.

On March 21, Cytel conducted a webinar with Alind on, “Transparent Machine Learning in Oncology”. Alind presented our continuing work in immuno-oncology using Bayesian network models for predicting safety and survival outcomes, extrapolating from limited follow-up data and validating with external real-world data for key subgroups. Continue reading for key highlights from the webinar.

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Interview with Alind Gupta: Transparent Machine Learning in Oncology

April 20, 2020

Cytel is hosting a webinar on Transparent Machine Learning in Oncology, on April 21, 2020. Our speaker, Alind Gupta, Machine Learning specialist, will provide insights on a particular transparent ML method called Bayesian networks, and how we have been using it for HEOR and other real world applications in oncology trials. As the adoption of machine learning is on the rise, we speak to Alind about the differences between black-box models and transparent machine learning, and how the latter is becoming more important in clinical research today. Alind also speaks about the application of ML on real-world data and how it is going to evolve in the coming years.

Machine learning (ML) aims to discover patterns from data that can be used for prediction, but the use of “black-box” ML models in healthcare research and decision-making has been limited, due to clinical liability and lack of trust from stakeholders. FDA guidelines for ML-based devices mandate transparency to assure continual safety and efficiency as notable recent failures have prompted increasing ML research into bias, fairness and causality. This has ramifications for all therapeutic areas but particularly within oncology.

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Webinar: Key Design Considerations for Basket Trials and Umbrella Trials by Jay Park

March 31, 2020

 

Since 1953, when the discovery of the structure of DNA was made, we have seen great advancements in genomics. Particularly, in the last few years, the industry has seen a rapid rate of adoption in biomarkers and how they can be used to improve biomedical interventions. Trial investigators have been showing interest in biomarker-guided trials such as basket trials and umbrella trials, developed under the master protocol framework. As a result, we have been seeing a rapid rate of adoption of these innovative trial methods.

In our previous blog, we spoke with Jay Park, Director, Cytel, about the concept of master protocols, their importance and future growth potential. On March 19, Cytel conducted a webinar with Jay on “Key Design Considerations for Basket Trials and Umbrella Trials”. This webinar introduced two master protocol types and explored their extension to design in various contexts from the HIV epidemic in global health to expedited oncology trials. Continue reading for key highlights from the webinar .

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Interview with Jay Park: The present and future of Master Protocols

March 12, 2020

In September 2018, the FDA provided a draft guidance on master protocols reflecting an increased interest in these designs by industry. This came after a 2017 editorial published by the Drs. Woodcock and LaVange from the FDA in the New England Journal of Medicine. In this guidance master protocol is defined as a protocol designed with multiple substudies, which may have different objectives and involves coordinated efforts to evaluate one or more investigational drugs in one or more disease subtypes within the overall trial structure. As the adoption of these innovative trial methods is on the rise, we speak with Jay Park, Director, Cytel, about the concept of master protocols, their importance and future growth potential. We take a closer look at their use in oncology trials where the increase in biomarker driven enrichment and stratification designs, as well as the use of companion diagnostics, ensures that master protocols are often adopted by trial investigators.

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