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

October 27, 2023
Written by Natalia Muehlemann, Vice President, Clinical Development; Martin Frenzel, Research Principal, Statistical...
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April 24, 2023
APAC Biopharma Industry Insights: Trends, Opportunities, and Challenges
In the last 10 years, the Asia-Pacific (APAC) region has become a hotspot for clinical trials: the region contributed...
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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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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 26, 2022
Discover the Value of an Optimized Clinical Data Strategy
To continue our Summer Weekend Reads series, Cytel presents “Discover the Value of an Optimized Clinical Data Strategy”...
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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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June 25, 2021
Leveraging External Data for Efficient Trial Designs
The main challenge associated with the development of therapies for rare diseases is typically the small study sample...
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June 4, 2021
Bayesian Methods: Paving the path to Clinical Development Transformation
Bayesian methods have been playing a key role in transforming clinical research in therapeutic areas such as oncology...
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January 30, 2019
Career Perspectives: Interview with Tina Checchio, Associate Director, Quantitative Pharmacology & Pharmacometrics
QPP remains at the heart of model based drug development. Short for Quantitative Pharmacology & Pharmacometrics, it...
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June 28, 2018
Non-Compartmental Analysis and the Early Phase Regulatory Environment
By Esha Senchaudhuri With thanks also to Jitendarreddy Seelam and Ramanatha Saralaya for their input. The fact of the...
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February 9, 2017
Inside an Oncology Statistician's Toolkit
In this blog, Adam Hamm, PhD, Director Biostatistics at Cytel shares some of the most important knowledge he uses in...
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May 10, 2016
Subgroup Analyses in Early Phase Clinical Trials
We were fortunate to welcome Björn Bornkamp of Novartis to the EUGM 2016 presenting work he has developed jointly with...
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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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April 7, 2016
Blinded SSR in early phase biosimilar studies
Francois Beckers, Global Head of Biostatistics & Epidemiology at Merck KGaA joined us at the East User Group Meeting in...
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March 29, 2016
Decision Making in Early Clinical Development
On March 16th and 17th the 5th East User Group Meeting took place in London. This very successful 2 days saw a variety...
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November 12, 2015
2 Talks on Early Phase Go/No-GO Decision Making
Last week Cytel joined forces with Sanofi/Genzyme to devote a full day of workshops and talks related to modern methods...
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October 19, 2015
3 Statistical Challenges for Pooling Phase 1 Data
It is often necessary to pool safety data from late phase studies, in preparation for regulatory submission. Some of...
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September 4, 2015
Using Simulation for Accelerated Early Phase Drug Development
Our Client's Challenge: Can knowledge of the relationship between biomarkers and clinical endpoints help us to optimize...
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September 1, 2015
Modern Early Phase Clinical Trial Design Primer
If you’re in the practice of conducting early phase clinical trials, you’ve probably heard that modern trial designs...
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August 10, 2015
Mitigate Phase 3 Clinical Trial Risk by Optimizing Phase 2 Data
When approaching a Phase 3 clinical trial, the need to ‘de-risk’ the massive investment often leads sponsors on a quest...
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May 20, 2015
Seamless Adaptive Clinical Trials: What’s really at stake?
Seamless adaptive clinical trials have gained popularity for reducing the projected time it takes to complete the...
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April 23, 2015
Dose-finding with Sequential Parallel Comparison Designs
Last week the Cytel Blog discussed the benefits of using the Adaptive Maximizing Design [AM Design] for dose-finding...
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January 22, 2015
Adaptive Clinical Trial Strategies for the Limited Early Phase Budget
The Journal of the American Medical Association recently published an article entitled ‘The Anatomy of Medical...
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January 20, 2015
Why Drugs Fail in Phase 3: A Cytel Infographic
According to a recent Cytel Whitepaper on Adaptive Clinical Trials, 50% of Phase 3 trials eventually fail. This new...
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December 18, 2014
Early Phase Development Strategy: Bayesian Methods for Go/No-Go Rules
Earlier this week, we at Cytel enjoyed a riveting in-house discussion on the uses of Bayesian decision rules for...
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November 18, 2014
A Bayesian Industry Approach to Phase I Combination Trials in Oncology
Statisticians and scientists at Novartis have been at the forefront of developing a new method in early phase oncology...
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