Perspectives on Enquiry & Evidence
Cytel's blog featuring the latest industry insights.
April 22, 2024
Written by Boaz N. Adler, Director, Global Product Engagement, and J. Kyle Wathen, Vice President, Scientific Strategy...
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March 13, 2024
Understanding Group Sequential Designs
Group sequential clinical trial designs — a type of adaptive clinical trial design — have emerged as a powerful tool in...
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March 11, 2024
Quantitative Strategies for Rare Disease Clinical Trials
In 2023, rare diseases accounted for 30% of product pipeline under development, about half of which comprising...
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January 15, 2024
Navigating the Clinical Development Landscape: Insights for Success in 2024
After explosive and frenetic activity in the clinical trial industry during the COVID era, the past two years have seen...
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December 29, 2023
The Top Most-Read Posts of 2023
What a year! Perspectives has explored a myriad of topics this year within clinical development — from adaptive trial...
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December 22, 2023
Top Therapeutics Development Topics of 2023
Perspectives covers a wide range of topics within therapeutics development from advice on regulatory submission to...
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December 20, 2023
Top Real-World Evidence and Real-World Data Topics of 2023
Perspectives covers a wide range of topics related to real-world evidence and real-world data, from overcoming health...
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October 30, 2023
Managing Uncertainty: Simulation-Based Assurance in Clinical Trial Design
The past two decades have seen the adoption of great innovation in clinical trial design. Statisticians have risen to...
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August 4, 2023
Bayesian Methods for Strategic Clinical Trial Design
“There is always the risk that interim analyses might occur after the Sufficient Information Threshold has been...
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August 1, 2023
Dynamic Bayesian Borrowing to Bolster Limited Sample Sizes in Rare Indications
Evaluating the efficacy and safety of novel therapies in rare indications can be challenging due to the difficulty of...
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April 18, 2023
Navigating Comparative Effectiveness in the Inflation Reduction Act: Methodological Approaches for Healthcare Challenges
The Inflation Reduction Act (IRA), passed in August 2022, marks a significant shift in the US healthcare landscape,...
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January 25, 2023
Bayesian Approach in Oncology Trials
People think in Bayesian terms all the time: we use prior information and the evidence at hand to make decisions in our...
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January 17, 2023
Bayesian Strategies in Rare Diseases
When it comes to rare diseases, a handful of major challenges to drug development arise. Bayesians strategies have...
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January 13, 2023
Bayesian Methods across the Clinical Development Journey
Bayesian methods, with their ability to facilitate flexibility and learning, are often associated with early-phase...
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January 12, 2023
Why Are There Not More Bayesian Clinical Trials?
Statistical methods have long been fundamental to drug development, and advancements in the last few decades in...
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December 29, 2022
Top Perspectives Articles of 2022
Perspectives on Enquiry and Evidence explores a wide variety of topics within clinical trial design and data science in...
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December 27, 2022
Top Bayesian Topics of 2022
Bayesian methods have been playing a key role in transforming clinical research, providing a variety of new...
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December 21, 2022
Top Interviews of 2022: Industry Voices and Career Perspectives
Perspectives on Enquiry and Evidence features two recurring interview series: Our new Industry Voices series, in which...
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December 16, 2022
Topics in Bayesian Statistical Methods
Bayesian methods have been playing a key role in transforming clinical research, and Bayesian topics are frequently...
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November 29, 2022
Bayesian Adaptive Clinical Trial Designs: INLA vs. MCMC
Bayesian methods have continuously played a key role in transforming clinical research in therapeutic areas such as...
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November 18, 2022
Industry Voices: Dr. Parvin Fardipour on New Horizons in Data Science
In the following interview, Dr. Parvin Fardipour, Quantitative Strategies & Data Science, sits down with Heather...
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November 2, 2022
Bayesian Hierarchical Modelling for Histology-Independent Therapies
Pharmaceutical research in oncology is increasingly focused on the development of therapies targeted at newly...
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October 5, 2022
Platform Trials, Can they Benefit Animal Studies?
Master protocols and platform clinical trials have become an innovative and efficient approach to testing multiple...
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October 4, 2022
MCMC vs. INLA in Bayesian Adaptive Clinical Trial Designs
Integrated Nested Laplacian Approximations (or INLA) are now starting to be used by statisticians as a key tool for...
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October 3, 2022
Bayesian Methods for Historical Borrowing: Conjugate Priors
The wider availability of electronic health data, medical registries, and even larger proprietary datasets means that...
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September 12, 2022
On Frequentist and Bayesian Sequential Clinical Trial Designs
In clinical trials, patient enrollment is often staggered, with data collected sequentially. When designing a clinical...
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September 9, 2022
Developing Synthetic Control Arms Using Bayesian Models
A new trend has emerged over the last decade that has changed the way many clinical trials are conducted. Unlike...
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September 2, 2022
Summer Weekend Read Roundup
Last week, we featured our final Summer Weekend Read, the last in a series designed to showcase some of our most recent...
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August 18, 2022
Highlights from JSM 2022
The American Statistical Association’s annual Joint Statistical Meeting (JSM) gathered over 6,500 attendees from 52...
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August 3, 2022
The Uses of Bayesian Methods in Late-Phase Clinical Trial Strategy
A number of late-phase clinical trial sponsors remain hesitant to employ Bayesian approaches in confirmatory settings,...
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May 16, 2022
Cytel & ARCS Collaborate to Strengthen Early Phase Capabilities
A combination of industry and policy forces have recently changed the shape of Australia’s R&D sector, making it a...
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December 23, 2021
Year-End Roundup: Your Favorite Blog Posts of 2021
Cytel blogs bring you debate and discussion of the newest trends in statistics and quantitative strategy. In 2021, our...
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December 8, 2021
Conditional Powers Vs Bayesian Predictive Power for Adaptive Sample Size Reassessment
Despite the debate in the scientific community on adaptive sample size reassessment (SSR), noteworthy developments have...
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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 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 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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December 21, 2020
Year-End Roundup: Your Favorite Blog Posts of 2020
2020 has been an unusually difficult year as the global pandemic impacted all of our lives. This year, the Cytel blog...
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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 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 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 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 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 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 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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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 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 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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July 27, 2020
Introduction to Population Enrichment by Dr. Thomas Burnett
Cytel is conducting a webinar series on complex innovative trial designs. Dr. Thomas Burnett, Senior Research Associate...
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July 23, 2020
Why Consider a Synthetic or External Control Arm?
Just as there are numerous adaptations that fall within the umbrella of adaptive designs, there are several different...
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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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June 27, 2020
New Whitepaper: Bayesian Methodologies for COVID-19 Drugs
Expert statisticians at Cytel have spent the past three and a half months designing and deploying dozens of trials for...
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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 18, 2020
Why You Should Construct Primary Endpoints Using Bayesian Methods
One of the revelations of the COVID-19 pandemic is that the flexibility and potential of Bayesian designs goes far...
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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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February 25, 2020
Bayesian Methods for Contending with Homogeneity and Heterogeneity in Real World Data
Over the past decade, a new trend began to emerge, changing the way that clinical trials are conducted. Whereas...
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August 31, 2018
Highlights from the JSM 2018 Conference
JSM 2018, ASA’s annual gathering of over 6500 attendees attracted statisticians and data scientists to the beautiful...
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July 2, 2018
Highlights from the PSI 2018 Conference
A number of the Cytel team were in Amsterdam, 3rd- 6th June 2018 for the PSI Conference. This year’s conference was...
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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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May 30, 2017
Interview: How can a Bayesian framework support benefit risk assessment?
A recent paper The case for Bayesian methods in benefit-risk assessment: Overview and future directions (1) co-authored...
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March 24, 2017
Case Study: Improving Go/No-go Decision-Making with Custom Software
Robust go/no-go (GNG) decision-making is essential for effectively managing risk across a clinical portfolio. In early...
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March 2, 2017
Case Study: Bayesian Decision-Making in a Phase 3 Oncology Design
We continue our case study series with this example of a Phase 3 design that uses Bayesian decision making combined...
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April 22, 2016
Dual Agent Dose Escalation Designs
FDA draft guidance on “Co development of two or more unmarketed investigational drugs for use in combination” notes...
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