Esha Senchaudhuri

Recent Posts

Why adaptive sample size re-estimation designs preserve type 1 error

Posted by Esha Senchaudhuri

Aug 28, 2014 8:00:00 AM

 

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Topics: Promising Zone, type 1 error, Adaptive Clinical Trials


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


New ISCB Course on Adaptive Design

Posted by Esha Senchaudhuri

Aug 19, 2014 8:48:00 AM

Biostatisticians from Cytel will be delivering a course on adaptive designs at this year’s International Society for Clinical Biostatistics. The course will help attendees develop strategies for interim decision-making, by providing an overview of recent advances in statistical methodology and applying them to case studies in oncology and cardiology

Members of Cytel Consulting are not only...

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Topics: Adaptive Clinical Trials


Backward Image Confidence Intervals for Adaptive Group Sequential Designs (Full Article Attached)

Posted by Esha Senchaudhuri

Aug 14, 2014 8:00:00 AM

Cytel statisticians are looking foward to attending the Conference of the International Society for Clinical Biostatistics, which will be held in Vienna during the week of August 24th. Members of Cytel will be contributing to four sessions at this conference, including an invited talk on innovation entitled 'Beyond Wild Horses: Developing Innovation at Cytel.' They will also be contributing to a...

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Topics: Cyrus Mehta, Access to Paper PDF, Adaptive Clinical Trials


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


Reflections on Statistical Entrepreneurship: An Interview with Nitin Patel

Posted by Esha Senchaudhuri

Aug 5, 2014 11:52:00 AM

Cytel CTO Nitin Patel, recently sat down with ECHOES (a magazine for statistics in clinical trials) to discuss his vision of the future of statistics and statistical programming within the biopharmaceutical industry.

Patel argues that the global reach of statistics in an era of big data will affect both statistical technique and communication. As a result, he encourages aspiring statisticians...

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Topics: Nitin Patel, Statistical Analysis, Entrepreneurship, Computing


Bayesian Approaches in Clinical Trials: Updates on Tools & Techniques

Posted by Esha Senchaudhuri

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...

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Topics: Dose-Escalation, Bayesian Methods


Why Using Adaptive Designs Can Attract Investors to Your Trial

Posted by Esha Senchaudhuri

Jul 29, 2014 6:30:00 AM

Adaptive designs are the unsurprising hot topic of this year’s Joint Statistical Meeting, which features over one hundred and thirty sessions on the subject. Statisticians at Cytel look forward to contributing to the dialogue with two papers on adaptive designs, and a workshop for using simulations to benefit from interim data (i.e. for prediction and trial forecasting.) In addition, Cytel...

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Topics: optimization, Adaptive Clinical Trials


Data Management and Biostatistics III: Statistical Innovation in Clinical Data Management

Posted by Esha Senchaudhuri

Jul 24, 2014 1:30:00 PM

This is the third post in a three part series in which we consider (i) improvements to trial quality that result from bundling data management with biostatistics, (ii) reductions in cost and study length that result from bundling data management with biostatistics, and (iii) the contributions of statistical innovation to clinical data management, such as those by Cytel Board member Professor...

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Topics: Data Management, Clinical Research Services, Marvin Zelen


To Adapt or Not to Adapt? 10 Simple Steps to Deciding Whether Your Next Trial Should be Adaptive

Posted by Esha Senchaudhuri

Jul 22, 2014 11:48:00 AM

 

PROCYSBI, the first drug to receive FDA approval after following an adaptive population re-assessment design, was one of Cytel's most exciting success stories. Could your drug be next?

 

It has become popular to rave about the many regulatory, statistical and financial benefits of adaptive designs when compared to the inflexibility of conventional trials. However, the reality is that not...

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Topics: Cytel Consulting


Predicted Interval Plots: A General Overview

Posted by Esha Senchaudhuri

Jul 17, 2014 7:00:00 AM

In anticipation of Cyrus Mehta’s webinar next week on new predictive analytics tools for trial forecasting, we thought we might give you a few introductory notes on the nature and purpose of Predicted Interval Plots (better known as PIPs).

What are PIPs?

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Topics: Trial Design, East PREDICT, Predicted Interval Plots, forecasting


Mehta Publishes Article on Adaptive Designs for Biomarker Driven Population Enrichment in Oncology

Posted by Esha Senchaudhuri

Jul 10, 2014 1:53:00 PM

Complexities with identifying suitable test populations in oncology studies contribute significantly to the 60% attrition rate in Phase III trials. Cyrus Mehta, (President of Cytel) has recently authored a paper on ‘Biomarker Driven Population Enrichment for Adaptive Oncology Trials,’ (forthcoming in Statistics in Medicine) which provides an innovative method for using two-stage adaptive...

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Topics: Oncology, Access to Paper PDF, Enrichment, Adaptive Clinical Trials


5 Reasons to Invest in Adaptive Designs for Population Enrichment

Posted by Esha Senchaudhuri

Jul 8, 2014 6:00:00 AM

The above graphic is from Cyrus Mehta's slides on 'Adaptive Population Enrichment for Oncology Trials with Time to Event Endpoints.'

 

Recent advances in precision medicine have meant that therapeutic treatments can now target subsets of a population that are most likely to respond well to treatment. Identification of such subsets largely relies on the presence or absence of particular...

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Topics: Oncology, Predictive Enrichment, Precision Medicine, Adaptive Clinical Trials


'Multivariate Approaches for Risk-Based Monitoring' An Adaptive Design (Slides Attached)

Posted by Esha Senchaudhuri

Jul 1, 2014 9:47:00 AM

A recent Cytel Seminar on Adaptive Statistical Designs featured a talk by Michael Elashoff (Patient Profiles) on Multivariate Approaches for Risk-Based Monitoring. Elashoff, a former statistical reviewer at the Food and Drug Administration, recommended combining cluster and rules based methods for statistical monitoring. Such adaptive monitoring approaches can substantially reduce the time and...

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Topics: Access to Slides PDF, Trial Quality, Trial Monitoring, Adaptive Clinical Trials


Adaptive Designs for Precision Medicine: A Look at Pfizer's Xalkori Trial (Slides Attached)

Posted by Esha Senchaudhuri

Jun 26, 2014 8:44:00 AM

The rise of biomarker based treatments in oncology has meant a reconceptualization of what constitutes a particular disease. According to the American Society for Clinical Oncology, “We can no longer think of cancer as one disease. Even something like lung cancer could be hundreds of different cancers, each defined by specific molecular characteristics requiring different treatment...

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Topics: Oncology, Access to Slides PDF, Precision Medicine, Adaptive Clinical Trials


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...

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


Data Management & Biostatistics II: Operational Benefits of Bundling

Posted by Esha Senchaudhuri

Jun 3, 2014 7:30:00 AM

This is the second post in a three part series in which we consider (i) improvements to trial quality that result from bundling data management with biostatistics, (ii) reductions in cost and study length that result from bundling data management with biostatistics, and (iii) the contributions of statistical innovation to clinical data management, such as those by Cytel Board member Professor...

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Topics: Data Management, Clinical Research Services


2014 Zelen Award Honors Statistician and Educator

Posted by Esha Senchaudhuri

May 29, 2014 9:58:00 AM

Cytel has taken the initiative to train the next generation of clinical programmers through its innovative Clinnical Programming Laboratory [see Cytel's CliPLab].

What about training the next generation of statisticians? The Harvard School of Public Health has just awarded the 2014 Marvin Zelen Leadership Award in Statistical Sciences to a distinguished statistician and educator. 

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Topics: Marvin Zelen, Training and Education, Statistical Puzzles


Cytel's CliPLab: Training the Next Generation of Clinical Programmers

Posted by Esha Senchaudhuri

May 27, 2014 7:09:00 AM

Although collaboration between industry and academia has been a longstanding tradition in the field of drug development, existing industry forces are reshaping the nature of this partnership. According to Cytel India's Chief Executive Ajay Sathe, the projected expansion of the drug development market between now and 2017, comes at a time when both industry and academia are challenged to supply...

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Topics: Clinical Research Services, Cytel CliPLab, Statistical Programming, Training and Education


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