Unveiling New East 6.5 Modules: Join Our Webinar

Posted by Cytel

Jul 3, 2018 4:15:47 AM

 

 It’s shaping up to be a busy year for Cytel’s software development team with a number of upgrades and planned launches across our range of tools. (Watch this space for announcements soon on new quantitative decision-making software OK GO and an upgrade to EnForeSys). East, our industry leading platform for clinical trial design, simulation, and monitoring will be unveiling version 6.5 in the Fall, and delegates at the PSI conference in early June had the chance to grab a sneak peek of the new functionality in one to one demos.

We’ll also be opening the hood on the new design capabilities you can expect in East 6.5 at a complimentary webinar on Wednesday July 18, 11:00AM - 12:00 US EDT (16:00 UK, 17:00 EU).

Our presenters Pantelis Vlachos and Charles Liu, will introduce the 3 new available modules and share their insights on the supporting methodologies and their practical applications. New developments in the East software are typically derived from two sources: our team’s interaction with our customers, particularly during East training; and from our consulting practice when we help clients design their trials.

The new modules in East 6.5 include:
MCPMod (design with Multiple Comparisons Procedures)

MCPMod allows you to measure the likelihood that particular dose-response curves are the right mathematical model for a given set of data. East MCPMod will allow designing a trial using optimal allocation and then analyze the trial data using various dose/model selection criteria resulting
into a solid base (target dose) for the next phase confirmatory trial.

Population Enrichment (Adaptive designs)

An adaptive enrichment design allows the full population is segmented during interim analyses. Recently, we worked with TRACON Pharmaceuticals to design their TAPPAS trial that incorporated a population enrichment component to help overcome the potential heterogeneity of treatment effect between subpopulations for an angiosarcoma design.

Program-Level Design
It is important to take a strategic approach to clinical development to minimize the potential for Phase 3 attrition. This new module will help users apply simulations to optimize their clinical trial programs.
Click the button below to secure your place at the webinar. 

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Topics: East, Trial Design, Program and Portfolio Optimization, Adaptive Clinical Trials, phase 2, Simulations


Career Perspectives: Interview with Namrata Deshpande, Senior Team Lead

Posted by Cytel

Sep 29, 2017 3:01:00 PM

Namrata Deshpande, Senior Team Lead will be participating in a round table discussion at the Women in Statistics event in California, October 19-21.

This is the first blog in a new 'Career Perspectives' series and we talk to Namrata to find out more on her career path, achievements, current role at Cytel and her interests outside of work. 

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Topics: East, Clinical Research Services, Statistical Programming, Statistical Analysis, Clinical Development Strategy, Statistical Innovations in Clinical Development, biostatistics, R programming, careers


Design Concept for Basket Trials: Interview with Bob Beckman

Posted by Cytel

Sep 11, 2017 11:25:00 AM

At the East User Group meeting (EUGM) on 25th and 26th October, we will welcome a number of renowned industry speakers to discuss some of the most promising approaches in innovative trial design. Over the next few weeks, we will profile a number of the speakers and their talks. In this blog, we talk with Bob Beckman M.D in advance of his presentation ‘Design Concept for a Confirmatory Basket Trial'. This, the first part of a two-part interview will reveal Bob’s insights into basket trials and their potential. The second part of the blog will delve more deeply into the design concept itself and will be published after the East User Group Meeting. To learn more, read on.

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Topics: Oncology, East, Clinical Research Services, Clinical Development Strategy, Statistical Innovations in Clinical Development, biostatistics, basket trials


Join us for the East Symposium and User Group Meeting

Posted by Cytel

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 great success with a  mix of scientific presentations, animated discussion, round tables and pre-conference software workshops. 

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Topics: East, Dose-Escalation, Adaptive Clinical Trials, Multi-Arm Multi-Stage Studies, biostatistics, EAST 6.4, adaptive designs


New East Insights Video:Creating an SSR Design

Posted by Cytel

Nov 9, 2016 9:03:11 AM


Adaptive sample size re-estimation designs are an important part of the statistician's toolkit. In this first in a series of East Insight videos, Cytel Statistician Charles Liu walks us through the creation of an adaptive sample size re-estimation design in East with a 5 minute demo. Watch the video and download the accompanying slidedeck to recreate the steps. 

 

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Topics: East, sample size re-estimation, adaptive sample size re-estimation, adaptive trials


How does the T-Statistic stack up for finding MTD?

Posted by Cytel

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.

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Topics: East, Dose-Escalation, Dose-Finding, Compass, biostatistics, adaptive designs, adaptive trials


PROC MCPMod in Bronchodilator Case Study

Posted by Cytel

Jul 5, 2016 8:00:00 AM

 

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. 

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


Determining the future course of your trial

Posted by Cytel

Jun 16, 2016 10:23:00 AM

 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.

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


EAST 6.4 Release: Interview with Yannis Jemiai

Posted by Cytel

May 31, 2016 7:30:00 AM

 

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


EAST takes on Multi-Arm Multi-Stage Designs

Posted by Cytel

Mar 11, 2016 12:30:00 PM

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.  

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


Translational Statistics: How to Move Beyond the Comfort Zone

Posted by Esha Senchaudhuri

Nov 6, 2014 11:09:00 AM

Professor LJ Wei holds that rules are for lawyers, not (necessarily) clinicians. When designing modern clinical trials, the impetus is often to use “efficient and reliable procedures, to obtain clinically interpretable results with respect to risk-benefit analysis…” Yet these efficient and reliable procedures are often just conventions and rules that provide information that is incomplete or difficult to make clinically interpretable.

In a presentation to the East User Group Meeting, Professor Wei identifies 11 problematic areas that currently challenge trial designers. After giving an overview of the challenges that arise in each, Professor Wei provides a few simple solutions about how to overcome them. All the solutions, however, require moving beyond the comfort zone of conventional procedures.

In the slides attached Wei discusses:

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Topics: East, East 6.3, Access to Slides PDF, Trial Design, Trial Monitoring, Training and Education, Predictive Enrichment, Precision Medicine, Translational Statistics, Translational Medicine


Clinical Impact Beyond 'Time to First' Analyses

Posted by Esha Senchaudhuri

Oct 21, 2014 9:00:00 AM

Every year, the East Users Group Meeting brings together notable experts from industry and academia to discuss the future of biostatistical advances in clinical trials, as well as the role of software in facilitating these breakthroughs. In honor of this year’s event, which will be taking place at the Loews Hotel in Philadelphia on October 22, the Cytel Blog will spend the next couple of weeks providing glimpses into the range of discussion presented at the EUGM table.

One debate that has already received quite some attention, involves the weighting of various morbidities in studies with composite endpoints. In a 2013 editorial in the European Heart Journal of the European Society of Cardiology, EUGM speaker Professor L.J. Wei and his colleagues wrote, "A reported P-value must not be confused with an assessment of the magnitude of a treatment's effect in a way that is meaningful to the patient, the clinician and the regulator." [1]

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Topics: East, East 6.3, Statistical Programming, Statistical Puzzles, Statistical Analysis, Cardiovascular


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

Posted by Esha Senchaudhuri

Jun 10, 2014 7:01:00 AM

 East: Learn More

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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Topics: Oncology, East, Regulation, FDA, East PREDICT, Predictive Enrichment, Interim Analyses, Prediction


The Perils of Poor Recruitment

Posted by Esha Senchaudhuri

May 5, 2014 10:21:00 PM

A new JAMA study on discontinued randomized trials in Switzerland, Germany and Canada, reports that poor recruitment accounts for 101 out of 253 trials that were eventually discontinued (or about 10% of the 1017 trials which participated in the study). When restricted to industry-sponsored trials with non-healthy volunteers, poor recruitment accounted for the discontinuation of 40 trials out of 119 that were discontinued. Across the board, poor recruitment was the foremost cause of trial discontinuity.

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Topics: Nitin Patel, East, East 6.3, Access to Slides PDF, Recruitment, East Recruit, Sample Size, Promising Zone, sample size re-estimation, Adaptive Clinical Trials


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