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

Time_to_Adapt

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 expert biostatisticians. In addition, they have practical experience designing adaptive trials for some of the leading biopharmaceutical companies in the industry. They will draw on this experience to cover topics on:

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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 session called Adaptive Designs II, in which they will discuss Backward Image Confidence Intervals, a solution to the problem of parameter estimation at the end of an adaptive trial.

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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/.
********************
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 wants, Henry Ford was able to revolutionize the automotive industry with the first 26-horsepower engine for the Cadillac Automobile Company (then known as the Henry Ford Company). Not long afterwards, Ford designed the engine for the Ford Model 999 racer, with a reported horsepower of over 86. He went on to develop the Ford Model T and Model A, and the Ford Trimotor aircraft. 
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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 modules are posited to transform early phase dose-escalation and interim decision-making. The Reverend has also made scene-stealing cameo appearances in a number of projects with Cytel Consulting.

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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 to gain a solid foundation in advanced computational methods, Bayesian techniques, and also a range of global film and world literature. 

As a seasoned entrepreneur, Patel also discusses what he views as three critical factors for successful entrepreneurship. Drawing on his experiences as a founder of Cytel, and also from his several years of teaching at the MIT Sloan School and the Indian Institute of Management, Patel notes the importance of developing risk-taking abilities, and drawing on trust and teamwork to counter some of the uncertainties of an unconventional career path. 

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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 enrollment prediction, which is essential for proper trial forecasting and interim decision-making.

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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 Senior Director & Consultant Jim Bolognese has organized a session on making use of adaptive designs to optimize strategy for drug development programs.

In the Ernst & Young 2014 Biotechnology Industry Report, Cytel CTO Nitin Patel writes: "Historically, biotechnology companies haven't fully appreciated the link between trial design and the ability to secure external financing. Yet, adaptive trial designs - which often reduce the risk, time and cost associated with clinical development - can make the math more attractive for investors." [Beyond Borders, p. 20]. 

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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 Marvin Zelen (Research Professor and former Chair of Biostatistics at the Harvard School of Public Health.)

For previous posts click here: 

“They’d report somebody dead, and two months later they’d report that the person was taking therapy.” [1]

This was clinical data in the early 1960s, according to Marvin Zelen, Research Professor in Biostatistics at the Harvard School of Public Health. More precisely, this was emblematic of the type of frustration that led Zelen and others at the Eastern Cooperative Oncology Group to develop the role, function and methodology of ‘data management’ in efforts to improve data quality for confirmatory clinical trials. 

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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 every trial benefits from such designs. While many trials gain considerable improvement to clinical utility with the choice of an adaptive method, others perform just as well with more conventional study designs. 

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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 designs for population enrichment.

Mehta, et al., are sensitive to the dilemma faced by Phase III trial designers choosing between open and restricted enrollment. Open enrollment allows for a large number of patients, and ensures that all patients who may benefit from a therapy have an opportunity to be involved. By contrast, limiting enrollment is a superior practice for revealing the efficacy of a trial for a targeted population. The proposed method allows for biomarker driven enrichment at interim analysis, meaning that only those subgroups that appear to benefit from therapy need to progress to the second stage of the trial.

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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

Predictive_Enrichment

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 biomarkers. In order to determine whether or not such biomarkers have predictive diagnostic capabilities, the biomarkers must first be validated as reliable predictive indicators, and thereafter as responding efficaciously to treatment.

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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 expense of data monitoring while ensuring consistently high data quality. 

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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 approaches.” [1] This means that many oncology trials are slowly moving from large-scale studies of generic populations, towards a system where targeted therapies are offered to smaller sets of patients who all possess certain genetic characteristics.

Nina Selaru of Pfizer Oncology, recently gave a talk at a Cytel Seminar in San Diego in which she described a trial for Xalkori, a therapy for non-small cell lung cancer (NSCLC). Pfizer conducted two Phase 3 trials for Xalkori, one for patients who possessed anaplastic lymphoma kinase (ALK-positive patients) and another for other ‘unselected’ patients. The ALK-positive patients were found to respond very well to treatment. Unfortunately, the ALK-positive patients also displayed certain characteristics not present in the other patients: they were younger, non-smokers who displayed signs of adenocarcinoma. There was concern that these characteristics were driving the efficacy of Xalkori.

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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 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


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 Marvin Zelen (Research Professor and former Chair of Biostatistics at the Harvard School of Public Health.)


 

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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 new and innovative young talent. While some universities offer comprehensive programs in computation, programming, biostatistics and bioinformatics, such an all-encompassing curriculum is rare. Even when possible, the combined contributions of these disciplines to the day-to-day challenges of statistical analysis and data management are often difficult to comprehend without industry experience.

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


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