Slides: East User Group Meeting and Trial Design Symposium

Posted by Cytel

Dec 4, 2017 11:28:00 AM

In 2011, Cytel organized its first East User Group Meeting (EUGM) in Paris. Since then, we have held an EUGM almost every year, alternating between locations in Europe and North America.  These meetings have been a great success, giving opportunities for customers and industry colleagues to meet each other as well as with key opinion leaders, whilst learning more about our East software and providing critical feedback. 

This year, the EUGM was held in Cambridge MA on the 25th and 26th of October. In this blog we are delighted to share the slides from some of the speakers' presentations. 

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Topics: Cytel Strategic Consulting, Clinical Development Strategy, Adaptive Clinical Trials, Statistical Innovations in Clinical Development, EAST 6.4, adaptive trials

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

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 informative10-minute video replay of their talk which includes a modeling and simulation case study. 

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

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

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: Clinical Research Services, Clinical Development Strategy, Statistical Innovations in Clinical Development, biostatistics, 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 Trial'. This, the first part of a two-part interview will reveal Bob’s insights into basket trials and their potential. The second part of the blog will delve more deeply into the design concept itself and will be published after the East User Group Meeting. To learn more, read on.

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

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 leaders)  Cytel's Yannis Jemiai explored the key challenges facing oncology development today, and discussed how adaptive designs can help to improve researchers' probability of success. The article tackles the application of adaptive designs in both exploratory and confirmatory development and the potential benefits to stakeholders, including patients. 

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

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 picks this year. 

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

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 Lingyun Liu with TRACON Pharmaceuticals.  

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

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

Jim Bolognese named 2017 American Statistical Association Fellow

Posted by Cytel

May 22, 2017 9:00:00 AM

James (Jim) Bolognese, Senior Director, Strategic Consulting, Clinical Services at Cytel Inc. was named a 2017 fellow of the American Statistical Association (ASA). Jim will be officially honored by the ASA at the Joint Statistical Meetings in Baltimore, Maryland this summer.

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Topics: Cytel Strategic Consulting, Interim Analyses, Statistical Analysis, Clinical Development Strategy, Adaptive Clinical Trials, biostatistics, adaptive designs

FDA 22 Case Studies and Mitigating Phase 3 Risks

Posted by Cytel

Apr 11, 2017 10:29:00 AM

In a January 2017 paper (1), the FDA reviewed 22 case studies where promising Phase 2 trials did not result in efficacy, safety or both being confirmed in a Phase 3 trial.

At the outset, the authors of the paper are careful to state that the aim is not to assess why these unexpected results occurred, but rather to demonstrate how different trials contribute to developing our scientific understanding of the product.

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Topics: Clinical Development Strategy, Phase 3, Adaptive Clinical Trials, adaptive sample size re-estimation, biostatistics, adaptive designs

Infographic: 10 steps to consider before choosing an adaptive design

Posted by Cytel

Nov 21, 2016 11:42:00 AM

While adaptive designs can deliver significant benefits to clinical development-  including ethical benefits for patients, reduced costs, and improved likelihood of trial success- they are not suitable for every clinical trial.  In making the assessment of whether or not to choose an adaptive design, trial planners need to weigh the strategic benefits against the practical implications. 

We have previously discussed on the blog, the 10 steps proposed by Jim Bolognese and Ranganath Nayak to assist sponsors in making this decision. In this blog, we are delighted to share a simple infographic outlining the process. 

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Topics: Clinical Research Services, Interim Analyses, Clinical Development Strategy, trial planning, adaptive designs, adaptive trials, DMC, infographic

Simulations to optimize clinical trial programs

Posted by Cytel

Oct 11, 2016 9:31:00 AM

Its important to take a strategic  approach to clinical development  in order to minimize the potential for Phase 3 attrition. The below infographic, previously published on the blog highlights some of the approvability and economic reasons cited for Phase 3 failure , and the clinical development issues which may have had an impact. 

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Topics: Clinical Development Strategy, Phase 3, Dose Selection, phase 2, Simulations

Adaptive Designs: A Data Management Perspective

Posted by Cytel

Oct 7, 2016 8:29:00 AM

Adaptive designs have the potential to accelerate clinical development, and improve the probability of trial success. While the principle is simple- to reduce the uncertainty in clinical development by obtaining additional information from the ongoing trial- the statistical methodologies can be complex, and expert support is often required to conduct the clinical trial design. There's also complexity in the data collection itself, so knowledgable data management support is needed to successfully execute an innovative trial design.  In this blog, we take a look at 5 top considerations for successful adaptive trial data management. 

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Topics: Data Management, Clinical Development Strategy, Clinical Data, Adaptive Clinical Trials, EDC, data manager, adaptive designs, adaptive trials

Case studies:Learning from less-well understood adaptive designs

Posted by Cytel

Sep 29, 2016 9:28:14 AM

A paper "Best practices case studies for 'less well-understood' Adaptive designs", has been published by the DIA Scientific Working Group on Adaptive Designs as a twin document to the previously discussed "Challenges and Opportunities of 'Less Well Understood' Adaptive Designs".  This publication furthers understanding by reviewing 10 important case studies and sharing details on their design and operational characteristics, as well as related regulatory interactions.  

To read an abstract and details of the full publication click here. 

 In this blog we'll take a look at some of the case studies under discussion. 

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Topics: Rare Disease, Clinical Development Strategy, Adaptive Clinical Trials, Multi-Arm Studies, adaptive sample size re-estimation, Multi-Arm Multi-Stage Studies, EAST 6.4, adaptive designs, adaptive trials, Seamless designs

Practical Challenges of the LUNG-MAP study

Posted by Cytel

Sep 27, 2016 9:24:00 AM

The Lung-MAP  trial is an innovative biomarker driven 'precision medicine' study which evaluates five novel agents for the treatment of patients with advanced squamous cell carcinoma of the lung.  As well as exploring therapeutic options for this indication, it also aims to improve the drug development process. 

At a Cytel seminar earlier in the year, Antje Hoering of CRAB presented to delegates on some of the practical challenges of the Lung-MAP study.

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Topics: Oncology, Precision Medicine, Clinical Development Strategy, Phase 3, phase 2, EDC

An efficient tool for model based meta-analysis

Posted by Cytel

Sep 20, 2016 9:42:00 AM


Drug development is an expensive and risky business.  To maximize a compound’s ultimate chances of commercial as well as regulatory success it’s imperative that sponsors are building up a strong understanding of its characteristics relative to competitors.  This knowledge can support critical decisions along the development path, such as optimizing dosing, and selecting the best active control. Importantly, it also ensures the sponsor can build a body of evidence and quantify the benefits of the compound in the context of other treatment options.  This knowledge can streamline the path to drug approval and support the drug’s chances of commercial success when it reaches the market.

 Model based meta- analysis (MBMA) is becoming an increasingly utilized strategy to conduct this competitive benchmarking. 

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Topics: Clinical Development Strategy, pharmacometrics, clinical development, pharmacology

Getting the best out of your biometrics RFP

Posted by Cytel

Jun 23, 2016 7:21:06 AM


Vendor selection is a critical component of ensuring clinical trial success.  A 2015 report (1)  suggested that clinical outsourcing penetration will reach 72% by 2020- nearly 3 quarters of all clinical trials will be outsourced to professional CROs.  The process of vendor selection and management may be managed by the clinical operations teams within smaller companies, or by outsourcing and functional groups within larger organizations.  The RFP process is a critical part of vendor evaluation, involving significant effort from the sponsor and CRO to ensure that a well-constructed, accurate proposal is created which can deliver what the sponsor needs.

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Topics: Clinical Research Services, outsourcing, Clinical Development Strategy, EDC, database build

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