Highlights from PhUSE 2017

Posted by Cytel

Nov 17, 2017 5:00:00 AM

PhUSE 2017 took place in Scotland’s capital city Edinburgh, 8th - 11th October, and brought together a range of experts to tackle the most pressing issues facing statistical programmers today.  We found this year's event informative and well attended. In this blog we share some highlights from the sessions and posters the Cytel team attended.  We will share Cytel's own contributions in a...

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Topics: biostatistics, Interim Analyses, Statistical Programming, R programming, clinical trials, FDA, CDISC


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: biostatistics, Cytel Consulting, Clinical Development Strategy


Asking the Right Questions of Your Data: Experiences in Model Informed Drug Development

Posted by Cytel

Nov 6, 2017 5:28:43 AM

 At the Chief Medical Officer Summit earlier this year, Cytel's Director of Quantitative Pharmacology and Pharmacometrics Cecilia Fosser, and Senior Director, Business Development, Chuck Gelb presented on how model-informed drug development (MIDD) techniques can improve decision-making and Probability of Success ( PoS) of clinical trial programs.  In this blog, we share some highlights and the...

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Topics: model-informed-drug-development, pharmacometrics, biostatistics, Clinical Development Strategy


Career Perspectives: Interview with Namrata Deshpande, Senior Team Lead

Posted by Cytel

Sep 29, 2017 3:01:00 PM

Namrata Deshpande, Senior Team Lead will be participating in a round table discussion at the Women in Statistics event in California, October 19-21.

This is the first blog in a new 'Career Perspectives' series and we talk to Namrata to find out more on her career path, achievements, current role at Cytel and her interests outside of work. 

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Topics: biostatistics, Clinical Research Services, Clinical Development Strategy, Statistical Innovations in Clinical Development, Statistical Analysis, Statistical Programming, careers, East, R programming


Case Study: Accurate Event Prediction in a Cardiovascular Outcomes Research Trial

Posted by Cytel

Sep 20, 2017 8:50:19 AM

 

In this blog we share a case study of work our strategic consulting team conducted supporting accurate event prediction for a cardiovascular outcomes research trial using the Major Adverse Cardiac Events ( MACE) composite endpoint. 

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Topics: biostatistics, Cardiovascular, time to event trials


How to handle conservativeness of Exact p-value?

Posted by Ashwini Joshi

Sep 18, 2017 7:38:45 AM

 

By Ashwini Joshi

For small sample data or rare events data, exact non-parametric tests perform better than asymptotic tests. But they come with the disadvantage of conservativeness. Many corrections have been suggested to reduce this conservativeness but none of them solve the problems entirely.  StatXact provides various methods of computing exact p-values. Depending upon the problem at...

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Topics: biostatistics, p value, StatXact, exact statistics, Small Sample Sparse Data, Exact Tests


How can Novel Statistical Methods Tackle Antibiotic Resistance? Interview with Scott Evans

Posted by Cytel

Sep 13, 2017 9:00:00 AM

Antibiotic resistance is one of the greatest challenges facing human health today. We are excited to welcome Dr. Scott Evans of the Harvard T.H Chan School of Public Health (HSPH) to the blog to discuss how the novel statistical methods he is developing could help tackle this global crisis.

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Topics: biostatistics, Clinical Research Services, Clinical Development Strategy, Statistical Innovations in Clinical Development, Antibiotic resistance


Design Concept for Basket Trials: Interview with Bob Beckman

Posted by Cytel

Sep 11, 2017 11:25:00 AM

At the East User Group meeting (EUGM) on 25th and 26th October, we will welcome a number of renowned industry speakers to discuss some of the most promising approaches in innovative trial design. Over the next few weeks, we will profile a number of the speakers and their talks. In this blog, we talk with Bob Beckman M.D in advance of his presentation ‘Design Concept for a Confirmatory Basket...

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Topics: biostatistics, Clinical Research Services, Clinical Development Strategy, Statistical Innovations in Clinical Development, East, Oncology, basket trials


Highlights from the 2017 JSM Program

Posted by Cytel

Aug 15, 2017 7:16:00 AM

Last month, Cytel statisticians headed to Baltimore for the Joint Statistical Meetings and shared some of their latest research and insights.  In this blog we will summarize our highlights -both from Cytel contributions and the sessions Cytel delegates attended. We also provide access to the valuable slide decks from the Cytel authored presentations. 

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Topics: biostatistics, adaptive designs, Adaptive Clinical Trials, Interim Analyses, JSM


Case Study: Cross-study Efficiencies in Biometrics Outsourcing

Posted by Cytel

Aug 2, 2017 7:07:00 AM

As a  biometrics -focused CRO, Cytel regularly works across a program of studies, providing data consistency, and helping to minimize the oversight burden for the sponsor. In this case study, we describe our work with a client on two Phase 1 studies, and how we were able to carry a number of important efficiencies from the first study to the second.  

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Topics: biostatistics, Phase 1, outsourcing, Clinical Research Services, Statistical Programming, medical writing, clinical data management, Clinical Data


Are Adaptive Designs the Answer to Oncology Development Success?

Posted by Cytel

Jul 26, 2017 10:05:39 AM

Sadly, clinical development of anti-cancer therapeutics faces particularly high rates of failure, even in the context of low success in drug development as a whole. Operating costs for oncology trials are also higher than those observed across the spectrum of clinical development.  In a recent article produced for the Pink Sheet ( a leading provider of  insights and analysis for biopharma...

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Topics: biostatistics, Oncology, Phase 1, Phase 3, Clinical Development Strategy, Adaptive Clinical Trials


Don’t miss these 5 session picks at JSM

Posted by Cytel

Jul 25, 2017 7:37:09 AM

The Joint Statistical Meetings (JSM) is the largest and arguably most highly respected gathering of statisticians in the world.  It will bring together over 6000 statisticians and runs from Saturday, July 29, to Thursday, August 3, 2017. With over 600 sessions,  it can be a challenge to identify the most crucial ones to attend. To help out, we've asked some of the Cytel team for their top...

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Topics: biostatistics, Oncology, Clinical Research Services, Clinical Development Strategy, Adaptive Clinical Trials, Statistical Innovations in Clinical Development, Statistical Analysis, Statistical Programming


Case Study: Seamless Independent Data Monitoring Committee Support

Posted by Cytel

Jul 19, 2017 9:00:13 AM

With adaptive and innovative trial designs on the rise, operational implementation of interim analyses, including management of Independent Data Monitoring Committees is increasingly important.  In this blog, we will share a case study of how Cytel provided a client with seamless Independent Data Monitoring Committee support encompassing committee selection and management, independent...

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Topics: biostatistics, Clinical Research Services, Statistical Programming, Interim Analyses, ACES, DMC


Creating Data Visualizations with R and Shiny

Posted by Cytel

Jul 13, 2017 5:25:00 AM

By Tejasweeni Rajput

It’s been known for centuries that a picture can tell a thousand words. In an era of new technologies, and increasing volume of information, visualizations can help us to express complex data simply and effectively. Advanced technology is now available that allows statisticians and data scientists to drill down into the data sets to be analysed, and develop dynamic...

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Topics: biostatistics, Statistical Programming, Clinical Research Services, R programming


Collaboration Brings Success for the UK Adaptive Designs Working Group.

Posted by Cytel

Jul 11, 2017 6:57:00 AM

The Adaptive Designs and Multiple Testing Procedures Workshop (ADMTP), the first joint meeting of the Adaptive Designs Working Group of the MRC Hubs for Trials Methodology Research and the joint ADMTP Working Group of the International Biometrics Society German and Austro-Swiss Regions, took place in Cambridge, UK last month. 

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Topics: biostatistics, adaptive designs, Clinical Data, Adaptive Clinical Trials


When Biostatisticians Disagree About Ethics

Posted by Cytel

Jul 6, 2017 9:09:00 AM

 By Esha Senchaudhuri

The ethical benefits of adaptive clinical trials have been widely acclaimed: higher prospects for patients to be enrolled into the correct trial arm [1]; shorter trials for the most effective new therapies (see the early stopping outcome of the MUSEC trial) [2]; and enrollments commensurate with the needs of research, i.e. the last patient enrolled is not superfluous to a...

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Topics: biostatistics, Regulation, patient enrollment, Adaptive Clinical Trials, medical ethics


Under wraps: the importance of patient privacy

Posted by Manjusha Gode

Jun 28, 2017 4:36:40 AM

About the Author: Manjusha Gode has over 28 years' IT experience spanning delivery Management, quality management, software testing,  people management, process improvement and multi-locational operations.  She is a pioneering member of Cytel's clinical programming team.

 Clinical data transparency improves decisions for all healthcare stakeholders including patients, caregivers, healthcare...

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Topics: biostatistics, Statistical Programming, Clinical Research Services, CDISC, Regulation


Join us for the East Symposium and User Group Meeting

Posted by Cytel

Jun 26, 2017 8:28:03 AM

Since 2011 we have been celebrating Cytel's birthdays by holding an East Annual Symposium and User Group Meeting ( EUGM), alternating locations between Europe and the United States. Our keynote speakers have featured some of the industry's most eminent biostatistics thought leaders including Stuart Pocock, Dave DeMets, Chris Jennison, Sue Todd, and Franz Koenig.  Each annual event has been a...

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Topics: biostatistics, adaptive designs, Adaptive Clinical Trials, East, EAST 6.4, Dose-Escalation, Multi-Arm Multi-Stage Studies


Cytel ASCO 2017 Report

Posted by Cytel

Jun 20, 2017 7:17:47 AM

 At ASCO 2017, Cytel trial design experts joined our medical and academic colleagues to share the most recent innovations in cancer research.In this blog we will share the abstract and pdf of the poster presentation: TAPPAS: Adaptive enrichment phase 3 trial of TRC105 and pazopanib versus pazopanib alone in patients with advanced angiosarcoma (AAS), co-authored by Cytel's Cyrus Mehta and...

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Topics: biostatistics, Oncology, Phase 1, Phase 3, Clinical Research Services, Clinical Development Strategy, Adaptive Clinical Trials


Poster: Model Based Predictions of Pharmacodynamic Responses in Ulcerative Colitis Patients

Posted by Cytel

Jun 12, 2017 12:30:00 PM

The Population Approach Group in Europe (PAGE) represents a community with a shared interest in data analysis using the population approach. Each June, a meeting of the community is held at a different European location. At this year's meeting in Budapest, Hungary, Cytel's Director of Quantitative Pharmacology and Pharmacometrics, Cecilia Fosser, showcased innovative work on creating model...

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Topics: biostatistics, Statistical Analysis, pharmacometrics, pharmacology, Simulations


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