Perspectives on Enquiry & Evidence
Cytel's blog featuring the latest industry insights.
July 27, 2022
Written by Jing Ping Yeo and Charles Warne Adaptive designs are studies that “include a prospectively planned...
Read article
June 14, 2022
6 Key Trials for Understanding Adaptive Designs for Clinical Trials
Suppose you had to choose six clinical trials intended for registration with regulatory agencies, only six, to explain...
Read article
May 31, 2022
What it means to be a lead analyst on a Global COVID-19 Trial
The TOGETHER Trial for COVID-19 therapies, designed by clinical trial specialists at Cytel won the Society for Clinical...
Read article
May 3, 2022
Adaptive Designs for Early Phase Development: Are the questions right?
In 2005, Pfizer launched a Phase 1 trial for the kinase inhibitor crizotinib. Six years later, it was approved, thanks...
Read article
November 30, 2021
Dr. Julia Edwards Findings Promising Zone Designs
The aim of any clinical research is to detect the actual difference in treatment effect between two groups (power) and...
Read article
March 9, 2021
Seeing Uncertainty: New Frontiers of Statistical Communication
When statistical sciences were in their infancy, the communicative benefits of statistics were widely touted. Thousands...
Read article
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...
Read article
February 4, 2021
Simulation Based Clinical Trial Optimization
The past decade has witnessed the rise of simulations-based clinical trial optimization in a manner unimaginable to...
Read article
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...
Read article
January 29, 2021
Computation and Clinical Trial Design: New Directions
Historically, advances in the statistical design of clinical trials have accompanied progress within the science and...
Read article
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...
Read article
December 17, 2020
2020 Recap by Yannis Jemiai, Chief Scientific Officer, Cytel
As Chief Scientific Officer, Dr. Yannis Jemiai plays a pivotal role in maintaining Cytel’s well-established reputation...
Read article
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...
Read article
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...
Read article
December 3, 2020
New Whitepaper: Reimagining Clinical-Trials
Increasing Clinical Development Productivity Using Statistics and Cloud-Computing The need for Re-imagining Clinical...
Read article
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...
Read article
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....
Read article
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,...
Read article
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...
Read article
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...
Read article
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...
Read article
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...
Read article
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...
Read article
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,...
Read article
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....
Read article
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...
Read article
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...
Read article
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...
Read article
September 21, 2020
Novel Adaptive Platform Trial for COVID-19 Therapies
Cytel has designed and implemented a novel adaptive platform trial for early stage COVID-19. The severity of the...
Read article
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...
Read article
September 4, 2020
Cytel Co-Founder Cyrus Mehta Presents at the Heart Failure Collaboratory, a Public-Private Partnership with FDA
On Friday September 11, Cyrus Mehta, co-founder of Cytel, will be delivering a talk to the Heart Failure Collaboratory,...
Read article
August 26, 2020
Career Perspectives: Interview with Yannis Jemiai, Chief Scientific Officer
As Chief Scientific Officer, Dr. Yannis Jemiai plays a pivotal role in maintaining Cytel’s well-established reputation...
Read article
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...
Read article
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...
Read article
August 13, 2020
Webinar: Adaptive Designs for Dose Finding
Bjoern Bornkamp, Statistical Methodologist at Novartis and Jose Pinheiro, Senior Director, Johnson & Johnson provided...
Read article
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...
Read article
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...
Read article
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...
Read article
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...
Read article
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...
Read article
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...
Read article
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...
Read article
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...
Read article
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...
Read article
May 7, 2020
COVID-19: Trials, Designs and Tools for Promising Results - A Virtual Panel Discussion
An extraordinary amount of global research is underway as the COVID-19 pandemic continues to evolve and spread...
Read article
April 14, 2020
Early Insights from Cytel’s New COVID-19 Trial Tracker
Last week Cytel launched a COVID-19 Trial Tracker, an Open Access tool to track the global response to the coronavirus...
Read article
February 6, 2020
Is your data strategy set up to tackle key challenges in early clinical development?
In clinical development, a high-quality evidence package is a prerequisite for a new therapy to gain approval from...
Read article
January 30, 2020
Designing Event-based Studies: Interview with Pantelis Vlachos
The Cytel Trial Design Innovations (CTDI) Webinar Series recently hosted a webinar on designing event-based studies....
Read article
January 16, 2020
Adaptive Population Enrichment in a Phase III Oncology Trial
January’s Cytel Trial Design Innovations (CTDI) Webinar Series will feature Biostatistician and pioneering Bayesian...
Read article
December 18, 2019
Year-End Roundup: Your Favorite Blog Posts of 2019
With only two weeks left for this fabulous year to end, we would like to thank all our blog subscribers and new readers...
Read article
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...
Read article
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...
Read article
November 5, 2018
New publication addresses critical issues in ultra-orphan indications
Cytel biostatisticians Cyrus Mehta and Lingyun Liu, together with Charles Theuer, CEO of TRACON Pharmaceuticals have...
Read article
October 23, 2018
Career Perspectives: Interview with Munshi Imran Hossain, Senior Data Scientist
Cytel data scientists apply advanced statistical techniques including predictive modeling of biological processes and...
Read article
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...
Read article
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...
Read article
September 20, 2018
Career Perspectives: Interview with Adam Hamm, Director of Biostatistics
At Cytel we believe that expert statistical input has the power to shape the future of clinical development: de-risking...
Read article
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...
Read article
August 23, 2018
Career Perspectives: Interview with Meredith Alm, Manager, QA Compliance
Cytel has grown significantly over the last 30 years, with operations across North America, Europe, and India. All of...
Read article
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,...
Read article
July 24, 2018
Career Perspectives: Interview with Sam Hsiao, Associate Director, Strategic Consulting
At Cytel our strategic consulting team works on a wide range of projects including: Identifying the best clinical trial...
Read article
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...
Read article
March 16, 2018
Career Perspectives: Interview with Benjamin Esterni, Principal Biostatistician
At Cytel we believe that expert statistical input has the power to shape the future of clinical development: de-risking...
Read article
February 13, 2018
Career Perspectives: Interview with Ursula Garczarek, Associate Director - Strategic Consulting
Our strategic consulting team work on projects such as: Identifying the best clinical trial design, implementing...
Read article
January 26, 2018
6 Innovative Trial Design Videos
The Cytel YouTube Channel hosts a wealth of video presentations from Cytel experts as well as external industry and...
Read article
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...
Read article
October 27, 2017
Design Concept for Confirmatory Basket Trial Interview with Bob Beckman: Part 2
In this blog, we share the second part of our interview with Bob Beckman, about a design concept for a confirmatory...
Read article
July 11, 2017
Collaboration Brings Success for the UK Adaptive Designs Working Group.
The Adaptive Designs and Multiple Testing Procedures Workshop (ADMTP), the first joint meeting of the Adaptive Designs...
Read article
May 22, 2017
Jim Bolognese named 2017 American Statistical Association Fellow
James (Jim) Bolognese, Senior Director, Strategic Consulting, Clinical Services at Cytel Inc. was named a 2017 fellow...
Read article
April 25, 2017
Critical Operational Considerations for Interim Analyses
At a recent conference Adam Hamm, Director Biostatistics at Cytel, presented his thoughts on Best Practices and...
Read article
April 11, 2017
FDA 22 Case Studies and Mitigating Phase 3 Risks
In a January 2017 paper (1), the FDA reviewed 22 case studies where promising Phase 2 trials did not result in...
Read article
March 29, 2017
New Publication: Design and Monitoring of Multi-Arm Multi-Stage Clinical Trials
With an increasing interest in platform designs and other innovative designs that involve multiple comparisons over...
Read article
January 30, 2017
Accelerating development with combined SAD/MAD approach
Single ascending dose (SAD) and multiple ascending dose (MAD) studies are typically the first in human studies. They...
Read article
January 23, 2017
How to get the regulatory green light for your adaptive design?
As a group, Cytel had over 40 successful regulatory interactions last year, many of which supported approvals for...
Read article
January 16, 2017
Adaptive Design Approaches from Cardiovascular Clinical Trialists Forum
The Global Cardiovascular Clinical Trialists Forum is a key event bringing together leading experts from across the...
Read article
December 15, 2016
Adaptive Design CONSORT Extension Project: The Inside Scoop
In April, we interviewed NIHR research fellow Munya Dimairo about the paper, ‘Adaptive designs undertaken in clinical...
Read article
November 21, 2016
Infographic: 10 steps to consider before choosing an adaptive design
While adaptive designs can deliver significant benefits to clinical development- including ethical benefits for...
Read article
October 7, 2016
Adaptive Designs: A Data Management Perspective
Adaptive designs have the potential to accelerate clinical development, and improve the probability of trial success....
Read article
October 5, 2016
Challenges in Neuroscience Clinical Trials
While some progress has been made in terms of scientific development in Neuroscience and Neuropsychiatry indications,...
Read article
September 29, 2016
Case studies:Learning from less-well understood adaptive designs
A paper "Best practices case studies for 'less well-understood' Adaptive designs", has been published by the DIA...
Read article
September 7, 2016
Overcoming challenges of 'Less Well Understood' Adaptive Designs
In the 2010 draft FDA ‘Guidance for Industry on Adaptive Design Clinical Trials for Drugs and Biologics', the agency...
Read article
August 23, 2016
How does the T-Statistic stack up for finding MTD?
At the recent JSM meeting in Chicago, Cytel's Jim Bolognese presented the results of work he has conducted evaluating...
Read article
August 17, 2016
Adaptive Designs: In Conversation with the NEJM
Following the recent publication of their review article Adaptive Designs for Clinical Trials in the New England...
Read article
August 9, 2016
Operational and regulatory considerations in a promising zone trial
At the recent JSM Meeting, Cytel’s Yannis Jemiai presented the case study of the VALOR trial which used a promising...
Read article
July 18, 2016
Adaptive Design in the limelight with NEJM article
In order for adaptive designs to reach their potential, it’s critical that knowledge is effectively dissemirnated...
Read article
June 16, 2016
Determining the future course of your trial
Predicting the course of a clinical trial is something which people will always want to do-whether for statistical...
Read article
April 28, 2016
Adaptive Designs in Practice
Adaptive Designs in Practice: Interview with NIHR Research Fellow Munya Dimairo NIHR and University of Sheffield...
Read article