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Special Update: US House of Representatives Passes 21st Century Cures Act

Posted by Cytel

Jul 10, 2015 12:54:00 PM

Here at Cytel, we are engaging in a small celebration this afternoon, as the US House of Representatives has just passed the FDA Reform Bill more generally known as the 21st Century Cures Act.

Although this bill is widely viewed as a reform bill, it will provide extensive funding to both the FDA and NIH to ensure that clinical and pharmaceutical research lives up to its potential to deliver life-saving technologies in a faster, smarter way.

Title II of the act contains approximately 150 pages on drug development. We're sure some of you have read it through and through. However, for those putting off their summer reading until August, here are 4 exciting developments that we want all of our friends and affiliates to be aware: 

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Topics: Bayesian Methods, Regulation, Medical Devices, Adaptive Clinical Trials


3 Strategies to Combat Inferential Conservatism in Small Sample Sizes

Posted by Cytel

Jun 25, 2015 4:28:00 PM

When conducting a clinical trial with small or sparse data sets, statistical methods meant for large sample sizes may fail to obtain an accurate interpretation of data. This is where computationally challenging exact methods often come into play.

Exact methods, however, are inferentially conservative in the sense that due to small sample sizes, the actual Type 1 error rate is often smaller than the nominal (intended) rate [1]. There exists an array of strategies to combat this troublesome feature of exact tests, each of which varies along the parameter of computational complexity.

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Topics: Sample Size, Exact Inference, exact statistics, Small Sample Sparse Data


New Cytel Whitepaper: Monte Carlo Simulations for Patient Recruitment

Posted by Cytel

Apr 13, 2015 11:23:00 AM

Cytel has published a new whitepaper on Monte Carlo Simulations for Patient Recruitment, which illustrates how a technique already popular within industrial and business environments is now changing the game of data-driven patient enrollment forecasting. 

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Topics: White Paper, Software Simulations, patient enrollment, Monte Carlo


Data-Driven Trial Planning: An Interview with Pfizer's Chris Conklin

Posted by Cytel

Feb 12, 2015 2:59:00 PM


Data driven decision-making can ensure that every feasibility team achieves its enrollment milestones. By transforming how pharmaceutical companies and CROs conduct feasibility studies, new techniques in recruitment planning are affecting every aspect of trial planning and clinical development strategy.

We sat down with Chris Conklin, the Director of the Feasibility Center for Excellence at Pfizer (pictured below) to discuss innovative ways to think about enrollment factors, and how he uses high-precision forecasting tools like Cytel’s EnForeSys®.

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Topics: Clinical Development Strategy, feasibility studies, patient enrollment


Clinical Development & Statistical Methodology for Cardiovascular Risk Assessment

Posted by Cytel

Feb 3, 2015 2:00:00 PM

A new publication co-authored by Cytel Co-Founder and President Cyrus Mehta considers a range of clinical development methods for cardiovascular outcome trials. Cardiovascular outcome trials, (often referred to as CVOTs), reflect safety standards implemented by the FDA and EMA to determine whether or not new drugs impose undue cardiovascular risk on patients. CVOTs typically occur after Phase 3 trials, and often make up for the slow rate of observed events by enrolling thousands of patients. This adds substantial delay in getting a drug to market.

In this paper, Cyrus and his co-authors explore how adaptive and group sequential methods might shorten this process without compromising the quality of the trial. In particular they consider increases in sample size and early stopping boundaries. They consider the possible benefits of unblinded sample size re-estimation (also known as the Promising Zone Design) in CVOT trials. 

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Topics: Cardiovascular, Group Sequential, Adaptive Clinical Trials


Clinical Drug Development: Predictions & Trends for 2015

Posted by Cytel

Jan 6, 2015 4:00:00 PM

As we head into the new year, the life-sciences industry can look forward to some long awaited advances in pharmaceutical drug development. Here are our predictions for top trends to look out for in 2015.

1: The Arrival of Adaptive Financing:

Adaptive financing was an idea that was cultivated and nurtured by members and affiliates of Cytel. It is the idea that a financial strategy can be built around outcomes that are observed at certain decision points during clinical development (for example, at interim analyses.) Constructing designs with adaptive financing in mind helps provide potential investors and study sponsors with a monetary ballpark of how much innovation will cost, and how much they have the potential to save. This helps overcome one of the biggest bottlenecks in implementing safer and more efficient adaptive trials, namely the perception by many in the industry that these trials are risky.

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Topics: Entrepreneurship, Adaptive Clinical Trials


How to Incorporate New Technology into Your Clinical Development Strategy

Posted by Cytel

Dec 2, 2014 11:00:00 AM

During a recent DIA webinar on reinventing the clinical trial, Laurie Halloran (President of the Halloran Consulting Group) and Irving Dark (Senior Vice President at Cytel) weighed in on a wide array of recent technological breakthroughs that life sciences companies can leverage to simplify clinical development. Their discussion ranged from simple techniques to cut down the 80,000 sheets of paper used for the average clinical trial (“Take it to the Cloud!”) to remote centralized monitoring techniques that make use of cutting edge statistical innovations.

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Topics: Data Management, Clinical Research Services, Entrepreneurship


Michael Proschan on 'Blinded Adaptations, Permutations and t-tests' (Link to Slides)

Posted by Cytel

Oct 30, 2014 10:28:00 AM

 During last week’s East Users Group Meeting, Michael Proschan of the NIH and NIAID, gave a presentation on ‘Blinded Adaptations, Permutations and t-tests.’ Given the close connection between adaptive t-tests and adaptive permutation tests, Proschan argued that it is possible to determine the validity of an adaptive t-test from the validity of an adaptive permutation test. Proschan concludes that in adaptive settings, “permutation tests are often valid in adaptive settings, even if blind is maintained.”

Michael's slides are available below. You can also find two of his recent papers on blinded adaptations in the 'Related Items of Interest' section.  

View Slides

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Topics: permutations, Blind and Unblind Trials, t-tests, 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


Congratulations Germany!

Posted by Cytel

Jul 14, 2014 11:49:00 AM

Congratulations to Germany for a fantastic World Cup victory! Records broken and beautiful moments marked this World Cup as extraordinary. We are excited to celebrate this achievement with all of our German colleagues and friends. As the attached article shows, Germany was up against some (statistically) impossible phenomena in the figure of Lionel Messi.  

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Topics: Prediction, Statistical Analysis, Cytel Congratulates


De-Risking Drug Development using Adaptive Design

Posted by Cytel

May 13, 2014 8:31:00 AM

The VALOR trial recently applied a promising zone design to a Phase 3 evaluation of Vosaroxin, a candidate for the treatment of relapsed/refractory acute myeloid leukemia. CMO Dr. Adam Craig reports that there were intial anxieties about financing a trial that required 800 patients. However, a promising interim look raised investors' confidence in the treatment's success, leading to a high-powered trial of 712 patients.

 

To view a YouTube video of Dr. Adam Craig talking about the Phase 3 VALOR trial, click below.  

 
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Topics: Oncology, Promising Zone, sample size re-estimation, Movers & Shapers, Adaptive Clinical Trials


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