Interview: Clinical Trial Optimization with R

Posted by Cytel

Nov 28, 2017 10:27:00 AM

 

In this blog we turn to some reading matter, and interview Gautier Paux and Alex Dmitrienko about the recent book 'Clinical Trial Optimization with R'.  The book explores a unified and broadly applicable framework for optimizing decision making and strategy selection in clinical development, through a series of examples and case studies. To learn more, read on for Paux and Dmitrienko's insights.

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Topics: Cytel Consulting, Clinical Development Strategy, Software Simulations


The Cytel Story: In the Co-Founders' Own Words

Posted by Cytel

Nov 9, 2017 11:43:00 AM

 In this blog we are excited to unveil a new project which we have been hard at work on over the last few months. 

2017 marks a very special milestone for Cytel – our 30th anniversary.  Cyrus Mehta and Nitin Patel founded Cytel in 1987 with an initial objective to solve a specific problem in computational statistics.

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Topics: Cytel Consulting, Clinical Development Strategy, biostatistics


Accelerating development with combined SAD/MAD approach

Posted by Cytel

Jan 30, 2017 9:50:24 AM

Single ascending dose (SAD) and multiple ascending dose (MAD) studies are typically the first in human studies.  They seek to gain information on safety and tolerability, general pharmacokinetic (PK) and pharmacodynamic ( PD)  characteristics, and of course identify the maximum tolerated dose (MTD).

Conventionally, SAD  and MAD studies were conducted separately, but increasingly are combined into an ‘umbrella’ protocol which addresses both SAD and MAD objectives.

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Topics: Cytel Strategic Consulting, Cytel Consulting, Statistical Programming, Phase 1, Dose-Finding, Compass, Phase I, biostatistics, adaptive designs, adaptive trials


How to get the regulatory green light for your adaptive design?

Posted by Cytel

Jan 23, 2017 10:35:00 AM

As a group, Cytel had over 40 successful regulatory interactions last year, many of which supported approvals for innovative trial design approaches.  In this blog we look at some of the key success factors for regulatory interactions regarding adaptive designs.

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Topics: Cytel Strategic Consulting, Cytel Consulting, Regulation, biostatistics, adaptive designs, adaptive trials


Blinded SSR in early phase biosimilar studies

Posted by Cytel

Apr 7, 2016 10:30:00 AM

 

 Francois Beckers, Global Head of Biostatistics & Epidemiology at Merck KGaA joined us at the East User Group Meeting in March and presented case studies of Merck KGaA’s experiences with Blinded Sample Size Re-estimation in early phase studies, more specifically in the context of biosimilar studies.

 

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Topics: sample size re-estimation, Cytel Consulting, Cytel Videos, Phase 1, Early Phase Trials


Decision Making in Early Clinical Development

Posted by Cytel

Mar 29, 2016 11:00:00 AM

On March 16th and 17th the 5th East User Group Meeting took place in London.  This very successful 2 days saw a variety of talks on aspects of clinical trial design innovation.  Over the next couple of weeks, we will be reviewing some of the key topics which were addressed during the meeting.

In this post, we'll take a look at Paul Frewer of Astrazeneca's presentation on Decision Making in Early Phase Clinical Development.  This talk was very well received by the delegates and prompted plenty of discussion afterwards. 

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Topics: Bayesian Methods, Cytel Consulting, Cytel Videos, Phase 1, Early Phase Trials, phase 2


Cytel Case Study Series II: Adaptive Bayesian Design with Informative Prior

Posted by Cytel

Sep 15, 2015 3:56:42 PM

 

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Topics: Bayesian Methods, Cytel Consulting, Case Study, Adaptive Clinical Trials


Cytel Case Studies Series #1: Using Simulation for Accelerated Early Phase Drug Development

Posted by Cytel

Sep 4, 2015 10:30:00 AM

Our Client's Challenge:

Can knowledge of the relationship between biomarkers and clinical endpoints help us to optimize an early development program and improve the probability of selecting the right dose in Phase 3?

Our client approached us hoping to expedite dose-finding with biomarkers in Phase 1b, and to design an optimal Phase 2b clinical endpoint trial to maximize probability of correct Phase 3 dose selection.

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Topics: Cytel Consulting, Early Phase Trials, Clinical Development Strategy, Proof-of-Concept, Case Study, Biomarkers, Simulations


Dose-finding with Sequential Parallel Comparison Designs

Posted by Esha Senchaudhuri

Apr 23, 2015 3:53:00 PM

Last week the Cytel Blog discussed the benefits of using the Adaptive Maximizing Design [AM Design] for dose-finding trials involving clinical utility limiting therapies. However, there are other ways that a dose-finding trial can make use of frequent-adaptation maximizing designs. Here we look at what happens to early phase clinical development when an AM Design combines with another adaptive design that is slowly gaining popularity, namely the Sequential Parallel Comparison Design. 

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Topics: Cytel Consulting, Early Phase Trials, Clinical Development Strategy, Adaptive Clinical Trials, psychiatry and neuroscience


Cultivating Versatility in Statistical Consultants

Posted by Esha Senchaudhuri

Dec 16, 2014 4:56:00 PM

Richard Branson once wrote: “I have always valued capability over expertise. While you may need to hire specialists for some positions, take a close look at people who have thrived in different industries and jobs – they are usually more versatile, have transferable skills, and can potentially tackle problems creatively.”

He goes on to write: “Obviously a healthy mix of experience and novel thinking is the ideal, but on balance I would anticipate more fresh and objective solutions to flow from the smart and curious inexpert outsider than the ‘been there done that’ experts.”

Although the versatility to which Branson alludes is instrumental for successful statistical consulting, it is also obvious that an inexpert outsider would not be able to waltz into the drug development industry and make successful contributions. The expertise that is required is simply too much for a non-specialist. This raises an important question:

How should we, as an industry, walk this fine line between specialized expertise and versatile capabilities? 

Consider, for example, the list of seven questions provided below. 

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Topics: Nitin Patel, Cytel Consulting, Entrepreneurship, Clinical Development Strategy, Richard Branson


7 Reasons to Add a Statistical Consultant to Your Team

Posted by Cytel Consulting

Oct 14, 2014 11:05:00 AM

We are often asked how statistical consultants can add value to the clinical development process. What do they contribute to a winning strategy, and how do they optimize business decisions? 

Statistical consultants often have decades of experience in multiple aspects of clinical development, including trial design, portfolio optimization, and regulation. Having a broad and yet nuanced feel for the industry enables statistical consultants to generate novel solutions to an array of challenges faced while navigating clinical development.

If you are thinking of hiring a statistical consultant to your team, you should be aware of the many roles that they can play. Here are some of our consultants' favorite recent projects. 

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Topics: Data Management, Cytel Strategic Consulting, Cytel Consulting


You Own This!

Posted by Laurie Halloran (Guest Blogger)

Oct 7, 2014 2:00:00 PM

Guest blogger Laurie Halloran is the President and CEO of Halloran Consulting Group, a management consulting firm for the life-sciences industry. Here she offers her take on the importance of accountability, obligation and 'ownership' in consulting for pharmaceuticals and medical device companies.

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Topics: Clinical Research Services, Cytel Consulting, outsourcing


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


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


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


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


Frequentist? Time for an update!

Posted by Dr. Pantelis Vlachos, Director at Cytel Consulting

May 19, 2014 10:22:00 PM

Pantelis Vlachos, PhD, is a Director at Cytel Consulting. He works with a team of experts who regularly assist clinical study teams with the design and implementation of Bayesian methods. In this blog post, Pantelis describes key benefits of Bayesian analyses for clinical trials.

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Topics: Bayesian Methods, Cytel Consulting, Trial Monitoring


Cytel Joins DIA Discussion on Predictive Enrichment Strategies

Posted by Cytel Consulting

May 16, 2014 2:48:00 PM

Cytel Consulting's Zoran Antonijevic

The key focus of precision medicine is identification of patients who would most benefit from a treatment. Proper enrichment of patient population greatly improves the probability of regulatory approval as well as product differentiation through improved efficacy and safety. Greater product differentiation leads to greater market access, as reimbursement is now a key driver to commercial success.

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Topics: Enrichment, Cytel Consulting, Adaptive Clinical Trials


New JAMA Study Confirms Importance of Trial Design for FDA Approval

Posted by Cytel Consulting

Apr 24, 2014 11:00:00 AM

Here at Cytel we firmly believe that if you don’t get the design of a clinical program right, then nothing else matters. A study recently published by the Journal of the American Medical Association, once again confirms the vital importance of proper trial design for the timely approval of a new drug. The article reports that nearly half of all submitted NME applications fail upon first submission, and only half of those that fail are eventually approved. The median approval delay is a costly 435 days. At least 53.6% of the trials eventually approved would have benefitted from improved study design: 24 of the unsuccessful first-time applications (15.9%) resulted from uncertainties related to dose selection; 20 of the rejections (13.2%) were due to choice of study end points that failed to display a clinically meaningful effect; 20 of the rejections (13.2%) were a consequence of inconsistent results when different end points were tested; and 17 (11.3%) demonstrated inconsistent results when different trials or study sites were compared. Moreover, 89 (58.9 %) showed inadequate efficacy, raising a question about whether the dose had been selected properly.

Cytel has biostatisticians with broad experience in clinical trial and clinical development program design, including adaptive designs and designs for efficient dose-finding. We are eager to collaborate on your clinical programs to enhance their probabilities of success.

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Topics: Cytel Consulting, Trial Design, Efficacy, Regulation, Safety


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