
Perspectives on Enquiry & Evidence
Cytel's blog featuring the latest industry insights.

September 21, 2021
Earlier this summer, we published a series of articles on the need to utilize weighting and prioritization tools in the...
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August 13, 2021
Finding the Optimal Trial Design Using Operations Research Methods
With the cloud computing power that we have today, we can run simulation of 1000s of designs with each design...
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August 9, 2021
When to make decisions? Strategic planning of interim looks.
Recently we discussed examining clinical development through a Bayesian lens, in honor of Cytel co-founder Nitin Patel...
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May 14, 2021
Starting the Conversation Early: Incorporating Business Considerations in Optimal Selection of Trial Design
When developing clinical strategy, applying familiar business principles to the specific requirements of clinical...
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May 7, 2021
Never Miss the Optimal Study Design Options
When is a study design considered to be optimal? A good design performs well not only under the ideal target scenario...
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April 28, 2021
Trial Selection: From Art to Science
Recently, Cytel co-founder Professor Cyrus Mehta noted that, “Clinical trial design selection is too much like an art,...
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April 20, 2021
New Dimensions of Clinical Trial Optimization
For much of the past three decades, even as methodologies for clinical trial design have advanced and refined, the idea...
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March 19, 2021
5 Steps to Regulatory Success with Wearables Designs
The use of wearable and digital technology requires considerations for both drugs and devices regulations, and...
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March 18, 2021
Computing & Statistics: Are You Ready for the Industry Transformation?
Over the past ten years High-Performance Computing (HPC) has transformed medical research through advances in genomics,...
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March 12, 2021
Wearables: Translating raw data to actionable information
With wearables likely to become a regular part of clinical trial design, statisticians could benefit by familiarizing...
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March 11, 2021
Data and analysis in Modern Oncology Clinical Development
In the recent years, Oncology trials are seeing a technological shift that is expected to make them faster and more...
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March 5, 2021
Single Arm Multi-Stage Phase 2 Cancer Trials
Early stage Phase 2 clinical trials are often designed as multi-stage single arm trials, which quickly identify...
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February 26, 2021
Empowering Statisticians to Create Complex Bayesian Clinical Study Designs
In the world of clinical trials, the pace of innovation is accelerating, and approaches such as Bayesian methods are...
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February 25, 2021
Use of Wearables in Confirmatory Clinical Trials
The convergence of several distinct trends has made wearables an increasingly attractive option for use in confirmatory...
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February 19, 2021
Selecting Your Next Clinical Trial Design Using Quantitative Methods
C-Suite and R&D Decision-Makers are always striving to make evidence-driven decisions. Yet the rules by which evidence...
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February 18, 2021
Introduction to Evidence Synthesis and Bayesian dynamic borrowing
In the last few years, there has been a growing interest in historical borrowing or augmented trials. There is an...
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February 12, 2021
Leveraging Synthetic and External Control Arms Using Bayesian Methods
In recent times, Single arm trials are being increasingly used to assess new treatment interventions. They establish...
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February 11, 2021
The biostats and clinical overview of a growing clinical strategy
The past two years have witnessed a heightened interest in the use of wearables in clinical development. The unexpected...
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February 9, 2021
New Meta-Analysis in JAMA Uses Novel Quantitative Techniques to Demonstrate Baseline Characteristics Informing Response to Common Therapy for Kidney Cancer
Recent years have witnessed improving survival outcomes for those struggling with a range of common kidney cancers....
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February 2, 2021
Bayesian Methods for Master Protocols
As the use of master protocols becomes more prevalent in drug development, Bayesian methods are extensively used to...
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January 26, 2021
Cytel Thought Leadership on Power of Bayesian Methods
Bayesian models offer a flexible way of incorporating historical controls in the analysis of trial data (whether single...
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January 22, 2021
The Role of Real World Evidence after COVID19
COVID-19 has transformed the pharmaceutical industry in a manner that few could have predicted only a year ago. One of...
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December 16, 2020
2020 Recap by Pantelis Vlachos, Principal/Strategic Consultant, Cytel
As we prepare to close the door on 2020, we asked Pantelis Vlachos, Principal/Strategic Consultant for Cytel, to share...
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December 15, 2020
Satisficing, Optimizing and Globally Optimizing Trial Designs
When designing clinical trials, biostatisticians and clinical development teams are often faced with a conundrum. Given...
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December 9, 2020
7 Key Features of Strategic Clinical Trial Design
As a part of Cytel’s Advanced Design Framework, a new Framework for the statistical design of clinical trials, Cytel...
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December 3, 2020
New Whitepaper: Reimagining Clinical-Trials
Increasing Clinical Development Productivity Using Statistics and Cloud-Computing The need for Re-imagining Clinical...
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December 2, 2020
Program and Portfolio Optimization: A New Paradigm
Significant advances have been made to enhance the efficiency of clinical trial designs. However, the traditional...
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November 24, 2020
Cytel and Ingress Health at Virtual ISPOR Europe 2020
Virtual ISPOR 2020, held November 16 to 19, presented new opportunities for scientific interaction amongst HEOR...
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November 18, 2020
We can design over 100,000 clinical trials in less than an hour
The current state of the clinical trials industry faces a challenge that was only hypothetical three or four years ago....
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November 16, 2020
Bayesian Methods for Multiple Cohort Expansion (MuCE) designs
MUCE is a Bayesian solution for cohort expansion trials where multiple dose(s) and multiple indication(s) are tested in...
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November 12, 2020
Join Cytel and Ingress Health at Virtual ISPOR Europe 2020
Cytel and Ingress Health (now a Cytel company) will be contributing to a range of events at Virtual ISPOR EUROPE 2020,...
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November 11, 2020
Interview with Yannis Jemiai: Advanced Design Framework
The widespread use of cloud-computing has altered the clinical trial design process. Whereas three or four years ago,...
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November 5, 2020
Role of RWA in Transforming Oncological Research
In oncology, many manufacturers go into niche indications, where there are very specific tumors, and then they opt for...
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November 4, 2020
Cytel Introduces Advanced Design Framework: Part 3 - Communication Techniques to Ensure Alignment on Data-Driven Clinical Trial Designs
Cytel has recently revealed its Advanced Design Framework, a method developed by Cytel’s thought leaders that draws on...
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October 29, 2020
Advanced Design Framework: Part 2 - A Quantitative Evaluation Approach
Cytel has recently revealed its Advanced Design Framework, a method developed by Cytel’s thought leaders that draws on...
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October 27, 2020
Bayesian Dose-Finding Designs – An Overview
Cytel recently conducted a webinar on Bayesian Dose-finding Designs for Modern Drug Development, presented by Dr. Yuan...
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October 26, 2020
Need for Technology Solutions to Support Computationally
Pharmaceutical and biotech companies are under pressure to deliver more and deliver faster with fewer resources. The...
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October 23, 2020
Yuan Ji on U-Design: An All New Efficacy and Toxicity Dose-Finding Module
Cytel’s New Horizons Webinar Series introduces you to the latest innovations in statistical trial design. This webinar...
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October 22, 2020
An Interview with Bart Heeg (Part 2): New Trends in HEOR
In this two-part blog series, we interview Bart Heeg, Vice President HEOR and Founder at Ingress Health (A Cytel...
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October 21, 2020
Advanced Design Framework: Part 1 - Exploration of Design Space
Cytel has recently revealed its Advanced Design Framework, a method developed by Cytel’s thought-leaders after a decade...
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October 20, 2020
Interview with Thomas Wilke: Health Economics/World Evidence Studies
In this interview with Thomas Wilke, Principal Scientist at Ingress-Health (a Cytel company), we talk to him about his...
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October 19, 2020
The Uniqueness of COVID-19 Data Challenges; The COVID-19 trial tracker
COVID-19 has created extreme uncertainties -- a dearth of historical information combined with the need for safety,...
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October 15, 2020
An Advanced Design Framework for Clinical Development in the Era of Cloud-Computing
For over a decade, advanced trial design techniques have promised efficient trials with accelerated timelines,...
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October 14, 2020
The Increasing Importance of Health Economics
A credible evidence base is needed to support and document the economic value of new technologies and therapeutic...
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October 13, 2020
Introducing Observational Studies – Three Trends for Statisticians
The combination of greater access to electronic health records, bigger electronic claims datasets, and the need for...
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October 12, 2020
Bayesian Statistics and FDA Regulatory Acceptability
Cytel and Novartis are together hosting a complimentary Bayesian Virtual Symposium and an Interactive 7-part workshop....
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October 7, 2020
RWE Needs for Natural History Studies
With the rise in digital technologies, there has been an explosion in the volume and type of data sources. We can...
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October 5, 2020
The Meta-Analytic-Predictive Priors Generation and Comparisons
Staying abreast of the rapid pace of clinical development means adopting innovative or computationally intensive...
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October 1, 2020
Improve Trial Design with Sequential Design and Sample Size
Methods involving Group Sequential Designs are one of the earliest deviations from a traditional two-arm clinical trial...
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September 30, 2020
A Virtual Event Brought to you by Cytel and Novartis on Innovations
Today, there is a need for advanced quantitative techniques to combine all available information for better decision...
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September 29, 2020
The New Horizons Series: Adaptive Multi-arm Multi-stage Clinical Trials
Innovation in trial designs are offering new routes forward for organizations of any size. They are now also aligned...
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September 28, 2020
Advantages of platform designs for investigating COVID-19 therapies
Cytel has recently designed and implemented the TOGETHER Trials, funded by the Bill & Melinda Gates Foundation to...
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September 25, 2020
Use of External Controls in Clinical Development – Download Audiobook
Regulators in both the United States and Europe have responded positively to the use of synthetic control arms (SCA)s...
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September 17, 2020
East Alloy: Accelerating the pace of innovation
Keeping up with the rapid pace of clinical development means that we need to adopt the innovative or computationally...
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September 16, 2020
New Audiobook on Synthetic Control Arms
Synthetic control arms (SCA) are virtual trial arms that use historical claims data and observational data to simulate...
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September 9, 2020
Importance of Designing Clinical Trials from a Program Perspective
Cytel’s co-founder, Nitin Patel, conducted a webinar on designing clinical trials from a program-level perspective. His...
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August 31, 2020
Adopt innovative and computationally intensive designs with East Alloy
Pantelis Vlachos, Principal, Strategic Consultant at Cytel, conducted a webinar to introduce the capabilities of East...
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August 25, 2020
Nitin Patel on Designing Clinical Trials from a Program Perspective
It is important to take a strategic approach to clinical development in order to minimize the potential for Phase 3...
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August 19, 2020
Webinar on Adaptive Designs for Dose Finding: Part 2
Bjoern Bornkamp, Statistical Methodologist at Novartis and Jose Pinheiro, Senior Director, Johnson & Johnson provided...
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August 13, 2020
Webinar: Adaptive Designs for Dose Finding
Bjoern Bornkamp, Statistical Methodologist at Novartis and Jose Pinheiro, Senior Director, Johnson & Johnson provided...
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August 11, 2020
Optimizing Information in Trial Design and Implementation
While there is increasing optimism about the discovery of a COVID-19 vaccine, one of the less talked about aspects of...
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August 4, 2020
Estimands and their Implications on Clinical Studies
Last year, Paul Terrill, Associate Principal of Strategic Consulting at Cytel, presented an engaging webinar on the...
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July 22, 2020
Access Sustainable, Verified Innovation with East Alloy
Cytel brings to you a new blog series on technology and Bayesian decision-making by Pantelis Vlachos,...
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July 13, 2020
Interview with Dr. Thomas Burnett on Adaptive Enrichment
Cytel is hosting a complimentary webinar series that introduces biostatisticians and other members of the development...
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June 24, 2020
Webinar - Practical Model-based Approaches for Phase I Oncology Trials
Last week, Cytel conducted its third webinar in the new introductory webinar series on Complex Innovative Trial...
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June 15, 2020
Significance of Bayesian Model-Based Approaches in Oncology Trials: An Interview with Dr. Satrajit Roychoudhury
Cytel conducted a webinar with Dr. Satrajit Roychoudhury, Senior Director, Statistical Research and Data Science...
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June 11, 2020
Adaptive Bayesian Methods: The Secret Weapon in COVID-19 Vaccine Development
A recent Cytel panel led by Vice President of Strategic Consulting Natalia Muhlemann evaluated the role that Bayesian...
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June 10, 2020
Group Sequential Designs and Sample Size Re-estimation
Cytel is conducting a webinar series that introduces biostatisticians to some of the more commonly used complex...
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June 1, 2020
Webinar Replay: Innovative Drug Development at a Glance
In a recent interview with Cytel, Zoran Antonijevic, longstanding chair and leader of the DIA Adaptive Design...
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May 28, 2020
Implications for the Future of Drug Development in Emerging Economies
On May 7, Cytel and Certara conducted a virtual panel discussion on new opportunities and implications for the future...
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May 27, 2020
Group Sequential Designs and Sample Size Re-estimation
In this blog, we speak with Christopher Jennison, Professor of Statistics at the University of Bath, UK. Professor...
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May 18, 2020
Interview with Zoran Antonijevic on Adaptive Design Methods
In this blog, we speak with Zoran Antonijevic, longstanding chair and leader of the DIA Adaptive Design Scientific...
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May 5, 2020
Webinar: A Clinician’s Perspective on Cancer Drugs Development
Cytel's team of oncology trial design and advanced analytics experts are hosting a series of complimentary webinars...
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April 23, 2020
A Clinician’s Perspective on Cancer Drugs Development
Cytel is hosting a webinar, “A Clinician’s Perspective on Cancer Drugs Development”, on April 28, 2020. Our speaker,...
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March 5, 2020
Managing risk in clinical development: Is your data strategy fail-safe?
Generating high-quality clinical data is a vital but challenging task in modern drug development. Unfortunately, in the...
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January 22, 2020
What could you accomplish with a fresh approach to your clinical data strategy?
In the quest for clinical success, we all strive for evidence packages of the highest quality. If the clinical data is...
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January 8, 2020
How to optimize your data strategy to drive success in clinical development
In clinical development, data is the vital ‘foundation’ that supports your programs. To successfully bring a promising...
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November 5, 2019
Drug Development in Rare Diseases - Innovation in Statistical Thinking
Cytel is delighted to have Kannan Natarajan speaking at the “Complex Innovative Trial Design Symposium and East User...
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October 10, 2019
The Challenges of Rare Diseases in Clinical Trials Symposium and Hands-on East Training
A disease is generally considered to be rare if it affects one patient per 200,000 people (1) and most rare diseases...
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November 12, 2018
Can Statisticians Contribute to Enhance the Position of Patients in Clinical Trials?
In this blog, we talk with Robert Greene, Founder and President of the HungerNDThirst Foundation, about his upcoming...
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October 5, 2018
Interview with Stephen Senn: 70 Years and Still Here: The Randomized Clinical Trial and its Critics
We are delighted that Stephen Senn will be joining us at the EUGM on November 14th and 15th in Darmstadt, Germany. In...
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September 27, 2018
Decision Making in Development Programs with Targeted Therapies: with Heiko Götte
In this blog, we talk with Heiko Götte, Senior Expert Biostatistician at Merck about his upcoming presentation at...
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August 15, 2018
2018 East User Group Meeting Addresses Multiplicity Themes, with keynotes including Stephen Senn and Meinhard Keiser.
Cytel’s 7th East User Group Meeting (EUGM) will take place on November 14 & 15, 2018 at Merck in Darmstadt, Germany,...
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July 3, 2018
Unveiling New East 6.5 Modules: Join Our Webinar
It’s shaping up to be a busy year for Cytel’s software development team with a number of upgrades and planned launches...
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February 27, 2018
Congrats to Lipopharma and CLINGLIO Consortium on Recent Grant Award
We extend our congratulations to Lipopharma and the CLINGLIO project consortium on their recent 6,15M€ grant award by...
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October 31, 2017
Webinar Replay: Dual Target Methods for Go/No-Go Decision Making
As part of Cytel's new Trial Innovations Webinar Series, Pat Mitchell, Statistical Science Director at AstraZeneca...
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October 18, 2017
Webinar Replay: Phase 2 Trial Designs using Program-level Simulations
Cytel's new Trial Innovations Webinar Series provides a platform for the most promising new statistical approaches...
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June 8, 2017
Measuring Intergroup Agreement and Disagreement
Cytel's Madhusmita Panda presented at this year’s PSI Conference in the Innovative Methodology session on the topic of...
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December 4, 2014
Operationally Seamless & Inferentially Seamless Adaptive Designs
Fulyzaq® from Napo/Salix was the first drug ever to be approved using an adaptive two-stage "seamless" clinical trial...
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November 6, 2014
Translational Statistics: How to Move Beyond the Comfort Zone
Professor LJ Wei holds that rules are for lawyers, not (necessarily) clinicians. When designing modern clinical trials,...
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October 2, 2014
Bayesian-Bandit Adaptive Designs for Rare Disease Drug Development
Sofia S. Villar is a member of the DART (Design and Analysis of Randomised Trials) group at the MRC Biostatistics Unit...
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September 2, 2014
Impact of Study Design and Development Strategy on Pharmaceutical Programs and Portfolios
As more clinical trials make use of adaptive designs, investors have come to realize that high quality trial designs...
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August 26, 2014
Statisticians from Cytel, SAS and Stata talk Software Development
During an invited speakers session at the lnternational Society for Clinical Biostatistics, Cytel VP Yannis Jemiai was...
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August 12, 2014
What Horsepower Can Teach us about Well-Powered Trials
Beyond Wild Horses: Developing Innovation at Cytel "Horse-and-pony" by arjecahn on flickr. -...
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July 17, 2014
Predicted Interval Plots: A General Overview
In anticipation of Cyrus Mehta’s webinar next week on new predictive analytics tools for trial forecasting, we thought...
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April 24, 2014
New JAMA Study Confirms Importance of Trial Design for FDA Approval
Here at Cytel we firmly believe that if you don’t get the design of a clinical program right, then nothing else...
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