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

Role of Prediction and Causal Inference in Clinical Research

November 17, 2020

 

As a part of Cytel’s "New Horizons Webinar Series", Alind Gupta, Senior Data Scientist, presents case studies from his research on applying machine learning for predictive analysis and evidence generation.

The biopharmaceutical and healthcare industries now collect more data than ever before due to advances in the variety of information sources combined with the ability to store vast quantities of diverse data. Sophisticated machine learning (ML) and AI techniques allow us to access and analyze any combination of a multitude of data sources. The way that traditional controlled sources are viewed is being adapted in light of new evidence that emerges from real-world data. In his presentation, Alind introduces us to the concept of ML and Causal Inference and discusses case studies from randomized clinical trials and real-world data.

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EAST 6.4 Release: Interview with Yannis Jemiai

May 31, 2016

 

Last week, we were delighted to announce the release of East 6.4 bringing further cutting –edge approaches to the East user community. East is the industry standard platform for clinical trial design, simulation, and monitoring, improving scientific productivity during the critical planning stages of clinical development. In this blog we catch up with Yannis Jemiai, VP of Cytel  to gain some behind-the-scenes insights into the development and  new features of this important release.

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Simulation and Prediction for Adaptive Licensing Decision-Making

January 13, 2015

Janus was the Roman God of transitions, a deity with two faces, one looking towards the past and the other the future. It was only a matter of time therefore, that clinical trial simulators, and other purveyors of predictive analytics would adopt him as an embodiment of their core initiatives. The aptly named Janus Initiative aims to model decision pathways in clinical development, using powerful simulations to help inform multiple stakeholders on adaptive licensing decisions. The objective is to give every stakeholder in the process a sense of what consequences his or her decision-making will have on other stakeholders involved.

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Congratulations Germany!

July 14, 2014

Congratulations to Germany for a fantastic World Cup victory! Records broken and beautiful moments marked this World Cup as extraordinary. We are excited to celebrate this achievement with all of our German colleagues and friends. As the attached article shows, Germany was up against some (statistically) impossible phenomena in the figure of Lionel Messi.  

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Overcoming Prowell's Pitfalls: Cytel Weighs in on Strategies for Oncology Development

June 10, 2014

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The FDA’s Tatiana Prowell (Breast Cancer Scientific Lead in the Office of Hematology  & Oncology Products) recently gave an interview to the Nature Review Drug Discovery, in which she discusses the top three pitfalls faced by drug developers in oncology. Issues which Prowell cite include: selection of appropriate dosage, trial designs without sufficient thought given to interim data, and untimely decisions on the use of biomarkers.

According to the article, “some 90% of drugs that enter phase 1 eventually fail.” The prevalence of these pitfalls is noteworthy for oncology drug development, not least becaues of how easy they are to avoid.When coupled with innovative trial design can achieve significant benefits in efficacy and cost-effectiveness. For example, model-based dose-escalation methods can be used to improve the model dose toxicity profile of the drug in question. Cytel Statistician Charles Liu shows how simple it is to use Cytel’s software to select the optimal dose to carry forward.

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