2018 East User Group Meeting Addresses Multiplicity Themes, with keynotes including Stephen Senn and Meinhard Keiser.

Posted by Cytel

Aug 15, 2018 6:08:00 AM

 

Cytel’s 7th East User Group Meeting (EUGM) will take place on November 14 & 15, 2018 at Merck in Darmstadt, Germany, bringing together industry experts, thought leaders and applied statisticians to discuss the future of clinical trials.

The agenda has been developed collaboratively by the EUGM Scientific Committee, and keynote speakers will include Stephen Senn, Meinhard Kieser, Thomas...

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Topics: East, Bayesian Methods, Trial Design, Program and Portfolio Optimization, Adaptive Clinical Trials, phase 2, Simulations, adaptive designs


Unveiling New East 6.5 Modules: Join Our Webinar

Posted by Cytel

Jul 3, 2018 4:15:47 AM

 

 It’s shaping up to be a busy year for Cytel’s software development team with a number of upgrades and planned launches across our range of tools. (Watch this space for announcements soon on new quantitative decision-making software OK GO and an upgrade to EnForeSys). East, our industry leading platform for clinical trial design, simulation, and monitoring will be unveiling version 6.5 in...

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Topics: East, Trial Design, Program and Portfolio Optimization, Adaptive Clinical Trials, phase 2, Simulations


Career Perspectives: Interview with Andrea Hita, Biomedical Data Scientist

Posted by Cytel

Jun 7, 2018 8:39:00 AM

Cytel data scientists apply advanced statistical techniques including predictive modelling of biological processes and drug interactions to unlock the potential of big data.

In this blog from our Career Perspectives series, we talk to Andrea Hita, at Data Scientist at Cytel, to find out more about her career path, her current role at Cytel and her interests outside of work.

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Topics: Recruitment, Trial Design, adaptive designs, careers, model-informed-drug-development, clinical trials, data science, CRO, clinical research, R language, genetic algorithm


Career Perspectives: Interview with Omar Sefiani, Principal Statistical Programmer

Posted by Cytel

Apr 28, 2018 9:50:00 AM

Cytel has industry-leading experts in Statistical Programming, our programmers have years of SAS® Programming expertise, combined with in-depth knowledge of the specific clinical subject matter, which allows for competent and on-time completion of tasks.

In this blog, we talk to Omar, who is based in Geneva to find out more about his career path, current role at Cytel and his interests outside...

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Topics: Recruitment, Trial Design, Statistical Programming, Statistical Analysis, Phase 3, CDISC, careers, clinical trials, CRO, clinical research


Cytel Congratulates Lipopharma and CLINGLIO Consortium on Recent Grant Award

Posted by Cytel

Feb 27, 2018 4:38:00 AM

We extend our congratulations to Lipopharma and the CLINGLIO project consortium on their recent 6,15M€ grant award by the European Union’s Horizon 2020 program. Led by Lipopharma, the multinational consortium brings together 12 academic and industry organizations from Europe, Israel, and the USA.

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Topics: Oncology, Trial Design, adaptive trials, personalized medicine


Providing Evidence that Pollution Accelerates Skin Aging in Fast Moving Consumer Goods Trial

Posted by Cytel

Dec 19, 2017 6:11:00 AM

 

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Topics: Trial Design, Statistical Analysis, FMCG


Webinar Replay: Dual Target Methods for Go/No-Go Decision Making

Posted by Cytel

Oct 31, 2017 10:42:00 AM

As part of Cytel's new Trial Innovations Webinar Series, Pat Mitchell, Statistical Science Director at AstraZeneca presented the October webinar "Formal Go/No-Go decisions are a key component of risk management in early clinical development."

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Topics: Trial Design, Adaptive Clinical Trials, phase 2, go-no-go, clinical development, adaptive designs, Bayesian, custom software


Webinar Replay: Phase 2 Trial Designs using Program-level Simulations

Posted by Cytel

Oct 18, 2017 11:03:00 AM

 

Cytel's new Trial Innovations Webinar Series provides a platform for the most promising new statistical approaches helping to bridge the gap from methodology to implementation. Ultimately, our goal is to enable our audience to improve their chances of success in clinical development.

The series got underway in August with a webinar on ‘Phase 2 Trial Designs using Program-level Simulations,...

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Topics: Trial Design, Program and Portfolio Optimization, Adaptive Clinical Trials, phase 2, Simulations


Measuring Intergroup Agreement and Disagreement

Posted by Cytel

Jun 8, 2017 9:50:07 AM

 

Cytel's Madhusmita Panda presented at this year’s PSI Conference in the Innovative Methodology session on the topic of ‘Measuring Intergroup Agreement and Disagreement’.

In this blog, we share the context, abstract and slides from Panda’s presentation. 

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Topics: Trial Design, Interim Analyses, Statistical Analysis, Clinical Development Strategy, biostatistics


5 session picks for the JSM

Posted by Cytel

Jul 20, 2016 8:30:00 AM

The Joint Statistical Meetings is the largest and arguably most highly respected gathering of statisticians in the world.  It will bring together over 6000 statisticians for this year’s event in Chicago.   As a large meeting, it can be a challenge to navigate and find the sessions which are going to be most valuable for your work.  To help out, we've asked some of the leading lights of our...

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Topics: Oncology, Trial Design, biostatistics, adaptive trials, Biometrics, JSM


Operationally Seamless & Inferentially Seamless Adaptive Designs

Posted by Esha Senchaudhuri

Dec 4, 2014 11:30:00 AM

Fulyzaq® from Napo/Salix was the first drug ever to be approved using an adaptive two-stage "seamless" clinical trial design. However, when Napo Pharmaceuticals sought orphan drug status for Crofelemer (made from the croton lechleri plant, pictured above left), it received a short window from the FDA in which to complete a Phase 3 trial for safety and efficacy. Aiming to diminish both time and...

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Topics: Sample Size, Trial Design, Safety, type 1 error, Dose-Finding


Translational Statistics: How to Move Beyond the Comfort Zone

Posted by Esha Senchaudhuri

Nov 6, 2014 11:09:00 AM

Professor LJ Wei holds that rules are for lawyers, not (necessarily) clinicians. When designing modern clinical trials, the impetus is often to use “efficient and reliable procedures, to obtain clinically interpretable results with respect to risk-benefit analysis…” Yet these efficient and reliable procedures are often just conventions and rules that provide information that is incomplete or...

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Topics: East, East 6.3, Access to Slides PDF, Trial Design, Trial Monitoring, Training and Education, Predictive Enrichment, Precision Medicine, Translational Statistics, Translational Medicine


Bayesian-Bandit Adaptive Designs for Rare Disease Drug Development

Posted by Dr. Sofia Villar (Guest Blogger)

Oct 2, 2014 8:30:00 AM

Sofia S. Villar is a member of the DART (Design and Analysis of Randomised Trials) group at the MRC Biostatistics Unit in Cambridge England. She has recently been awarded the first Biometrika post-doctoral research fellowship. 

In the post below Villar offers her position on how challenges in rare disease drug development may be alleviated by Bayesian-Bandit adaptive designs. The "Multi-armed...

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Topics: Bayesian Methods, Trial Design, Rare Disease


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...

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


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


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...
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Topics: East 6.3, Trial Quality, Trial Design, Entrepreneurship


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


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...

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


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