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

November 29, 2023
A clinical trial is usually performed using some kind of comparator. This could be another drug on the market, or a...
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November 20, 2023
Guidelines Are Not Instruction Manuals: Customize Your Way to First-in-Human Clinical Trials
Interpreting all guidelines before your first-in-human clinical trials can be overwhelming. While guidelines are...
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November 13, 2023
First-in-Human Drug Substance and Formulation: The Challenge of Achieving Flexibility and Quality
For nonclinical studies that precede Phase I, a drug formulation in high doses and concentrations is required. While...
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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 23, 2018
Addressing Critical Unmet Oncology Needs in the Era of Precision Medicine
Our Industry Voices series showcases our clients’ innovative work and breakthrough therapeutics in oncologic...
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May 16, 2018
Rewriting the oncology textbook with cell-based immunotherapies
Our Industry Voices series showcases our clients’ innovative work and breakthrough therapeutics in oncologic...
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May 9, 2018
Innovative Oncology Trial Designs in Practice
As we prepare to head to ASCO in under a month's time, we are pleased to share a new ebook that showcases some key...
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August 2, 2017
Case Study: Cross-study Efficiencies in Biometrics Outsourcing
As a biometrics -focused CRO, Cytel regularly works across a program of studies, providing data consistency, and...
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July 26, 2017
Are Adaptive Designs the Answer to Oncology Development Success?
Sadly, clinical development of anti-cancer therapeutics faces particularly high rates of failure, even in the context...
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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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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...
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April 26, 2016
Overcoming Data Management Challenges in Oncology Studies
In this blog we’ll highlight some unique challenges that are encountered from a Data Management perspective when...
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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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April 5, 2016
What's the price of pharma innovation?
Cost of pharmaceutical development and R&D productivity is an ongoing industry concern, consistently discussed in the...
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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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June 5, 2015
Building Teams to Handle Unexpected Regulatory Agency Requests
Not long ago, one of our clients submitted Phase 2 and Phase 3 data for a new rare disease drug which had received...
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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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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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August 21, 2014
Bayesian Trial Designs are Safe, Efficient & Flexible: A Review of Published Phase 1 Studies
Use of the continual reassessment method (CRM) is safe, efficient, and flexible, according to a comprehensive review of...
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