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...

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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


Adaptive Dose Finding Using Toxicity Probability Intervals

Posted by Esha Senchaudhuri

Oct 28, 2014 9:30:00 AM

Phase 1 oncology trials typically use either rule-based methods or model-based methods to determine the most acceptable level of dose toxicity with which to move forward in Phase 2. This level of toxicity, called the maximum tolerated dose (or the MTD), is the dose which best balances the medical benefits of a higher dose with the risk of toxicity which comes from subjecting a patient to that...

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Topics: Oncology, East 6.3, Access to Slides PDF, East ESCALATE, Adaptive Clinical Trials


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...

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


Statisticians on Software Development Part II: The Philosophy Behind a Software Package

Posted by Esha Senchaudhuri

Sep 25, 2014 10:06:00 AM

 

East: Learn More  StatXact: Learn More Compass: Learn More

A few weeks ago, we posted a synopsis of an event held at ISCB Vienna in which statisticians from Cytel, SAS and Stata spoke about processes for developing software for statisticians. The button below will guide you to a copy of the presentation by...

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Topics: East 6.3, Cytel Consulting, Regulation, Statistical Programming, Entrepreneurship


Statisticians on Software Development Part I: Statisticians from Cytel, SAS and Stata talk Software Development

Posted by Esha Senchaudhuri

Aug 26, 2014 3:00:00 PM

During an invited speakers session at the lnternational Society for Clinical Biostatistics, Cytel VP Yannis Jemiai was joined by R.N. Rodriguez from the SAS Institute and IR White (formerly of Stata), to discuss innovations in software for clinical trials.

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Topics: East 6.3, Trial Quality, Trial Design, Entrepreneurship


What Horsepower Can Teach us about Well-Powered Trials

Posted by Esha Senchaudhuri

Aug 12, 2014 8:30:00 AM

Beyond Wild Horses: Developing Innovation at Cytel

"Horse-and-pony" by arjecahn on flickr. - http://www.flickr.com/photos/arje/95322238/.
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Automotive affluential, Henry Ford, once said: "If I'd asked customers what they wanted, they would have told me a faster horse!" 
 
Thanks to a keen understanding of customers' needs and not merely a statement of their...
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Topics: East 6.3, Trial Quality, Trial Design, Entrepreneurship


The Rev Bayes Parties with Cytel at JSM 2014

Posted by Esha Senchaudhuri

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...

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Topics: East 6.3, Dose-Escalation, Bayesian Methods, Cytel Consulting, East PREDICT, East ESCALATE


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...

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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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