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, our Hrishikesh Kulkarni takes us on a tour of his life as a Cytel software trainer and answers some frequently asked questions about how East training sessions work in practice.

Topics: Trial Design Software, EAST 6.4, Multi-Arm Multi-Stage Studies, East ESCALATE

Photo by Dose Media on Unsplash

By Charles Liu, Senior Product Manager, Cytel

Several years ago, I was one of few Luddites in my social circle still using a “dumb” phone. Other than calls, and (text only!) messaging, it had no other functionality. Once I made the switch, a whole new magical world unveiled itself. With the tap of a button, I could read my email, listen to a podcast, find a...

Topics: Trial Design Software, EAST 6.4, Sample Size

The  Cytel YouTube Channel hosts a wealth of video presentations from Cytel experts as well as external industry and academic speakers about various aspects of clinical trial designs and their implementation.  In this blog, we've gathered 6 popular resources from the channel on topics from quantitative decision-making through to overcoming challenges in management of oncology trials. Read on...

Topics: biostatistics, Adaptive Clinical Trials, adaptive designs, Multi-Arm Multi-Stage Studies, Multi-Arm Studies, EAST 6.4, East PREDICT, pharmacometrics, model-informed-drug-development, Cytel Videos

In 2011, Cytel organized its first East User Group Meeting (EUGM) in Paris. Since then, we have held an EUGM almost every year, alternating between locations in Europe and North America.  These meetings have been a great success, giving opportunities for customers and industry colleagues to meet each other as well as with key opinion leaders, whilst learning more about our East software and...

Topics: EAST 6.4, Adaptive Clinical Trials, adaptive trials, Statistical Innovations in Clinical Development, Clinical Development Strategy, Cytel Strategic Consulting

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

A paper "Best practices case studies for 'less well-understood' Adaptive designs", has been published by the DIA Scientific Working Group on Adaptive Designs as a twin document to the previously discussed "Challenges and Opportunities of 'Less Well Understood' Adaptive Designs".  This publication furthers understanding by reviewing 10 important case studies and sharing details on their design...

Topics: Clinical Development Strategy, adaptive designs, adaptive trials, Adaptive Clinical Trials, adaptive sample size re-estimation, Seamless designs, Rare Disease, Multi-Arm Multi-Stage Studies, Multi-Arm Studies, EAST 6.4

 

Challenge:

Our client, an emerging biotechnology company, was preparing for the next stage of development for their novel compound in a rare disease.  They had two major concerns which they wanted the clinical trial design to address- an anticipated difficulty in recruiting subjects to the trial, and  the cost and time investment associated with running separate phase 2 and phase 3 trials. ...

Topics: biostatistics, adaptive trials, EAST 6.4, Seamless designs, phase 2, Phase 3, Clinical Research Services, Cytel Strategic Consulting

 

Topics: biostatistics, adaptive trials, Dose-Escalation, EAST 6.4, East ESCALATE, BLRM, CRM, Oncology, Early Phase Trials, Eearly Development

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

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

 

At a recent PhUSE SDE, Cytel’s Chitra Tirodkar presented how East PROC MCPMod could be used  to  help solve the problem of uncertain true dose-response relationship in a bronchodilator study.  In this blog we summarize some of the issues, and make Chitra's slides available for download. 

Topics: Dose-Finding, Dose Selection, MCP-Mod, Statistical Programming, SAS, East, EAST 6.4

 Predicting the course of a clinical trial is something which people will always want to do-whether for statistical reasons, planning reasons or business reasons. In this blog we look at examples of where prediction goes off course, and how we can resolve these issues.  We also share valuable video and slidedeck resources from our VP Consulting and Software, Yannis Jemiai.

Topics: East, East PREDICT, Interim Analyses, Cytel Videos, Cytel Events, clinical development, EAST 6.4, adaptive designs, adaptive trials, DMC

 

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...

Topics: East, Bayesian Methods, East PREDICT, Prediction, Software Simulations, Multi-Arm Studies, Multi-Arm Multi-Stage Studies, biostatistics, EAST 6.4, adaptive trials

There has been increasing interest in  multi-arm multi-stage trials with treatment selection and sample size re-estimation at interim analysis. The East 6.4  release incorporates new Multi-Arm Multi-Stage (MAMS) module to support statisticians designing these studies.  In this blog, we take a high level look at some of the features and advantages of this approach.  

Topics: East, Adaptive Clinical Trials, Multi-Arm Studies, Multi-Arm Multi-Stage Studies, EAST 6.4

( 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