Jun 26, 2017 8:28:03 AM
Since 2011 we have been celebrating Cytel's birthdays by holding an East Annual Symposium and User Group Meeting ( EUGM), alternating locations between Europe and the United States. Our keynote speakers have featured some of the industry's most eminent biostatistics thought leaders including Stuart Pocock, Dave DeMets, Chris Jennison, Sue Todd, and Franz Koenig. Each annual event has been a...
Topics: biostatistics, adaptive designs, Adaptive Clinical Trials, East, EAST 6.4, Dose-Escalation, Multi-Arm Multi-Stage Studies
Feb 9, 2017 7:34:58 AM
In this blog, Adam Hamm, PhD, Director Biostatistics at Cytel shares some of the most important knowledge he uses in his day to day work as a biostatistician working extensively in oncology research. Adam has broad experience with statistical analysis and methodology over all phases (I-IV) of development, in particular working in the oncology arena.
As a Director of Biostatistics at...
Topics: Oncology, Dose-Escalation, Dose-Finding, biostatistics, adaptive trials, Interim Analyses, Phase 1, phase 2, Phase 3, Early Phase Trials
Sep 2, 2016 10:30:00 AM
Topics: biostatistics, adaptive trials, Dose-Escalation, EAST 6.4, East ESCALATE, BLRM, CRM, Oncology, Early Phase Trials, Eearly Development
Aug 31, 2016 1:11:57 PM
Traditional rule-based approaches to dose escalation such as 3+3 are widely used in early clinical development. They can be appealing due to the simplicity of execution. However, estimates produced may be highly variable and the targeting of true Maximum Tolerated Dose may be poor. Bayesian dose escalation approaches in early phase trials can offer an effective alternative to determining the...
Topics: biostatistics, adaptive trials, Dose-Escalation, EAST 6.4, East ESCALATE, BLRM, CRM
Aug 23, 2016 9:00:00 AM
At the recent JSM meeting in Chicago, Cytel's Jim Bolognese presented the results of work he has conducted evaluating the T-Statistic ( or T-Stat) method for adaptive dose finding of MTD. In this blog we'll provide a brief summary of Jim's findings, and share his slides with our blog readers.
Topics: biostatistics, adaptive trials, adaptive designs, Dose-Escalation, Dose-Finding, Compass, East
Jul 21, 2016 6:30:00 AM
Did you miss our webinar on Single and Dual Agent Dose escalation designs earlier in the year? In this blog we have made the replay available for your review, and also take the opportunity to recap key reasons why you should consider a model based design for your dose escalation study.
Topics: Oncology, Dose-Escalation, Bayesian Methods, EAST 6.4
Nov 10, 2015 4:00:00 PM
Last week Cytel joined forces with Sanofi/Genzyme to devote a full day of workshops and talks related to modern methods in early phase oncology.
Topics: Dose-Escalation, Bayesian Methods
Nov 18, 2014 4:32:00 PM
Statisticians and scientists at Novartis have been at the forefront of developing a new method in early phase oncology trials called the BLRM. Many believe that the BLRM, (short for the Bayesian Logistic Regression Method,) allows for the construction of clinical trials that have the dual benefit of improving treatment for patients participating in the trials, and allowing the trial to complete...
Topics: Dose-Escalation, Bayesian Methods, Phase 1, Early Phase Trials
Sep 4, 2014 1:10:00 PM
Imagine if we were to count the number of possible reasons that investigators might have for monitoring a biomarker during a clinical trial, and multiply that number by the number of possible adaptive designs available for such investigation. We would naturally assume that whatever the number, it would be rather large. This poses an interesting question for a sponsor of an adaptive clinical...
Topics: Access to Paper PDF, Dose-Escalation, Cytel Strategic Consulting, Adaptive Clinical Trials
Aug 21, 2014 10:03:33 AM
Use of the continual reassessment method (CRM) is safe, efficient, and flexible, according to a comprehensive review of 53 published Phase I trials from 2003-2013. The review, just published in the Journal of Clinical Oncology by leading researchers Iasonas and O'Quigley, challenges common misconceptions about model-based dose escalation designs.
Topics: Dose-Escalation, CRM, Phase 1
Aug 8, 2014 9:00:00 AM
Photos leaked from JSM 2014 appear to show the Reverend Bayes partying with his entourage at the Cytel Cocktail Hour, held at Boston’s Seaport Hotel on August 4, 2014. Bayes is, of course, one of the stars of Cytel’s East 6.3, a modular software package driving drug development through high quality trial design and simulations. Bayes's contributions to the East ESCALATE and East PREDICT...
Topics: East 6.3, Dose-Escalation, Bayesian Methods, Cytel Consulting, East PREDICT, East ESCALATE
Jul 31, 2014 4:26:00 AM
Statisticians at Cytel are staunch advocates of the use of Bayesian methods in clinical trials. This summer's Joint Statistical Meeting will feature a panel on "Study Milestone Timeline Projection in Multi-Center Trials: Bayesian and Frequentist Approaches with Real-Life Applications" with three papers co-authored by Cytel experts. The Cytel papers will center on Bayesian approaches for ...
Topics: Dose-Escalation, Bayesian Methods
Jul 15, 2014 8:00:00 AM
Do you design or analyze Phase 1 dose escalation trials? Have you considered methods other than 3+3? This new Cytel video demonstrates how East ESCALATE can help you to explore your options.
Topics: Dose-Escalation, Bayesian Methods, Cytel Videos
May 8, 2014 7:54:00 AM
( Editor's note: This post has been refreshed in December 2016)
Model based algorithms for Phase I dose-escalation have been in existence for nearly thirty years. Despite guarantees of increased statistical power and greater accuracy, there remains a clear preference for rule based algorithms amongst clinicians. The explanation for this is as old as the models themselves.
Topics: Oncology, Dose-Escalation, Bayesian Methods, EAST 6.4, East ESCALATE