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 Cytel's Vice President of Consulting, Yannis Jemiai.

In the presentation, Yannis talks about the decision-making process behind software development, and how it aligns with a general philosophy to empower, simplify and educate. He explains how software developers choose from a variety of statistical algorithms in putting together a classic software package. "Just because we can," he cautions, "doesn't mean that we should." 

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


Adaptive Clinical Trials: Your Questions Answered

Posted by Cytel Consulting

Sep 23, 2014 11:32:07 AM

If you're a company considering an adaptive trial for the first time, you probably have many questions. One of our customers recently sat down with us to discuss some anxieties about an adaptive trial. The ensuing discussion included senior members of Cytel Consulting. Here's a transcript of  our conversation. 

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5 Scenarios When ‘Keep it Simple’ May Be Bad Advice for Clinical Trial Designers

Posted by Esha Senchaudhuri

Sep 18, 2014 10:44:00 AM

When designing clinical trials, many trial designers are advised to keep the trial simple. Prima facie, the keep it simple principle seems like sound advice. There are various logistical uncertainties that arise when implementing a clinical trial, and the more simple a trial – so conventional wisdom says – the easier it is to respond to these uncertainties.

According to Zoran Antonijevic, a Senior Director at Cytel Consulting, there is reason to doubt such conventional wisdom. After all, flexibility is hardly a virtue of a traditional trial design. Simple designs may seem to make it easier to monitor data and report results. However, a flexible design can better address remaining uncertainties in product development. These uncertainties are related to treatment effect, dose selection, or a sub-population that would experience the best benefit/risk from the treatment.

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Topics: Oncology, Promising Zone, sample size re-estimation, Enrichment, Cytel Consulting, Efficacy, Interim Analyses, forecasting, optimization, Program and Portfolio Optimization, R&D, Adaptive Clinical Trials


FDA Industry Session Features Panel on "Seamless Adaptive Designs"

Posted by Cytel

Sep 16, 2014 3:30:00 PM

An FDA Industry Statistics Workshop on September 23 will feature a panel on seamless adaptive designs. Seamless adaptive designs are studies which are able to combine two stages of a clinical trial into one adaptive study, thereby cuting trial costs and reducing study length. The panel will feature Cytel Statistician Lingyun Liu,Lisa Kammerman of AstraZeneca, and Joshua Chen of Merck. The FDA's Sue-Jane Wang will be the featured discussant.

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Topics: Cytel Consulting, Adaptive Clinical Trials


Empirical Study Confirms Positive Impact of Adaptive Designs

Posted by Esha Senchaudhuri

Sep 11, 2014 11:56:00 AM

According to a recent Impact Report from the Tufts Center for the Study of Drug Development, 21% of active clinical trials improve trial success rates and cut operating costs by designing trials with simple adaptive elements like sample size re-estimation and opportunities for early stopping. 

Cytel Senior Biostatistician Zoran Antonjevic, who also chairs the DIA’s Adaptive Design Scientific Working Group (ADSWG), says the CSDD's findings come very close to the numbers reported by the ADSWG. The ADSWG recently updated its published findings in a Therapeutic Innovation & Regulatory Science article entitled, ‘Adaptive Design: Results of 2012 Survey on Perception and Use.’ The Survey team, led by Cytel statistician and Senior Director Caroline Morgan, used a variety of source material to report on adaptive designs in clinical trials between 1996 and 2012.

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Topics: White Paper, Adaptive Clinical Trials


FDA-Industry Session on Cardiovascular Outcome Trials: Mehta on EXAMINE Trial’s Promising Zone Design

Posted by Esha Senchaudhuri

Sep 9, 2014 10:41:00 AM

 

The FDA requires sponsors of new antidiabetic drugs to conduct cardiovascular outcome trials (CVOTs). CVOTs demonstrate that new therapies do not place unacceptable cardiovascular risk on patients suffering from Type 2 diabetes. The average CVOT requires about 5000 patients and takes an average of 5 years to complete. However, a recent white paper by the Cardiac Safety Research Consortium outlines a variety of methods to decrease sample size and study duration, by employing group sequential and adaptive CVOT designs. 

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Topics: Cyrus Mehta, Promising Zone, Trial Design, FDA, Interim Analyses, Cardiovascular, Adaptive Clinical Trials


Adaptive Designs for Evidence Based Oncology: Insights from the Experts

Posted by Esha Senchaudhuri

Sep 4, 2014 1:10:00 PM

Imagine if we were to count the number of possible reasons that investigators might have for monitoring a biomarker during a clinical trial, and multiply that number by the number of possible adaptive designs available for such investigation. We would naturally assume that whatever the number, it would be rather large. This poses an interesting question for a sponsor of an adaptive clinical trial. Are there any general principles for trial design that may be gleaned from these various possible scenarios?

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Topics: Access to Paper PDF, Dose-Escalation, Cytel Strategic Consulting, Adaptive Clinical Trials


Impact of Study Design and Development Strategy on Pharmaceutical Programs and Portfolios

Posted by Esha Senchaudhuri

Sep 2, 2014 11:19:00 AM

As more clinical trials make use of adaptive designs, investors have come to realize that high quality trial designs can result in significant improvements to a trial’s financial risk profile. Regardless of a trial’s eventual success or failure, a well-constructed design provides a drug with the highest possible probability of success while mitigating financial risk.

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Topics: Nitin Patel, Cyrus Mehta, Promising Zone, Trial Quality, Cytel Strategic Consulting, Trial Design, Entrepreneurship, Program and Portfolio Optimization, R&D, Adaptive Clinical Trials


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


Bayesian Trial Designs are Safe, Efficient & Flexible: A Review of Published Phase 1 Studies

Posted by Charles Liu

Aug 21, 2014 10:03:33 AM

 

 

Use of the continual reassessment method (CRM) is safe, efficient, and flexible, according to a comprehensive review of 53 published Phase I trials from 2003-2013. The review, just published in the Journal of Clinical Oncology by leading researchers Iasonas and O'Quigley, challenges common misconceptions about model-based dose escalation designs.

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Topics: Dose-Escalation, CRM, Phase 1


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


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