Perspectives on Enquiry & Evidence
Cytel's blog featuring the latest industry insights.
March 13, 2024
Group sequential clinical trial designs — a type of adaptive clinical trial design — have emerged as a powerful tool in...
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February 26, 2024
Sample Size Re-Estimation for Rare Disease Clinical Trials
Written by Boaz N. Adler, MPA, Director, Global Product Engagement, and Valeria Mazzanti, MPH, Associate Director,...
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February 20, 2024
Negative Binomial Distribution in Group Sequential Designs
In clinical trials based on count data, the aim is to compare independent treatment groups in terms of the rate of...
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January 26, 2024
Parameter Optimization of Multi-Arm Multi-Stage Designs
Innovations in the process of designing adaptive clinical trials have unlocked new possibilities for designing and...
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November 8, 2023
Aligning Clinical Trial Design with Investment Priorities
Written by Natalia Muehlemann, Vice President, Clinical Development, and Ari Brettman, Senior Managing Director,...
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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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May 5, 2023
Scott Gaines on the Power of Simulation-Guided Design to Handle Increasingly Complex Clinical Trials
As clinical trials become more complex, simulation-guided design approaches are crucial. For this edition of the...
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March 24, 2023
Winter Weekend Read Roundup
Last week, we featured our final Winter Weekend Read, the last in a series designed to showcase our complimentary...
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March 17, 2023
Optimizing Small Clinical Trials with Simulation-Guided Design: A Case Study
Smaller clinical trials can be optimized in significant ways using simulation-guided design. A small biotech studying...
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February 22, 2023
Simulation-Guided Design for Biotechs
Simulation-guided design is quickly becoming a novel feature of modern drug development. Its foundational promise is to...
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February 9, 2023
Supercharging Quantitative Decision-Making with Simulation-Guided Trial Design
Those familiar with simulation-guided design (SGD) know that it can be used for a wealth of clinical trial options:...
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January 20, 2023
Strategic Clinical Trial Design Unlocks Innovative Funding Opportunity
A small biotech’s conventional carcinoma trial design was too expensive to implement and did not offer the opportunity...
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January 6, 2023
Simulation-Guided Design Is Reshaping Clinical Trial Strategy
You may have heard that our clinical trial strategy platform Solara® won the Fierce Life Sciences award for Technology...
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October 28, 2022
Measuring Robustness of Clinical Trial Designs with Pressure Tests
Integrating the “pressure testing” of clinical trial designs into the process of creating a strong clinical trial...
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June 2, 2022
Digital Transformation for Clinical Trials
How can clinicians at the forefront of modern clinical trials and statisticians at the forefront of advanced...
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May 24, 2022
Leveraging Advanced Statistical Software to Optimize Clinical Development
Traditionally, clinical trials are expensive, long in duration, and have low success rate. But with the advent of rich...
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April 27, 2022
Reinventing Clinical Trial Design: Digital Development
New medicines and devices under development live and die on the strength of their clinical data. An asset’s journey is...
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April 8, 2022
Robust Trial Design Under Treatment and Enrollment Uncertainty
The planning and optimization of a clinical trial is beset by uncertainties: knowledge of treatment effects, the...
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April 5, 2022
Time Check: Developing New Therapeutics
Hello! I’m delighted to pen my inaugural blog post here as Cytel’s Chief Medical Officer. In this series, we’ll explore...
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March 23, 2022
How to Use Historical Data to Mitigate Clinical Trial Risk
For over a decade, the number one reason cited for trial discontinuity has been challenges associated with recruitment...
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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 7, 2021
Anna Forsythe on Aligning Clinical Strategy with Regulatory and Market Objectives
Sponsors bringing a successful new product to market have to overcome two hurdles: submission and reimbursement. For...
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November 17, 2021
Using Tech to align Regulatory and Market Access Evidence strategies
Traditionally, the teams responsible for clinical development and regulatory submissions do not consult the market...
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November 10, 2021
Evolving the Study Design Process: An ACT Webcast by Dr. Yannis Jemiai
There are many reasons why traditional approaches to designing a clinical study are generally suboptimal and do not...
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November 2, 2021
Empowering Trial Selection: An ACT Webcast by Dr. Yannis Jemiai
A good clinical study design performs well not only under the ideal target scenario. Statisticians should be able to...
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October 27, 2021
Leveraging Staged Investment Strategy for Funding Novel Therapies
A staged investment strategy aligns R&D decisions and financial planning with the interim looks of a clinical trial. If...
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October 20, 2021
Strategic Clinical Trial Design Unlocks Innovative Opportunity
For health innovators, trial selection is a key success factor as there are no second chances. But how do you find the...
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October 14, 2021
Weighting and Prioritization for Trial Selection: New Webinar
When choosing the optimal clinical trial design for a given study, sponsors face critical questions like choice of...
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September 21, 2021
Three Underappreciated Benefits of Pareto for Empowered Trial Selection
Earlier this summer, we published a series of articles on the need to utilize weighting and prioritization tools in the...
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September 14, 2021
Career Perspectives: Interview with Alyssa Biller, Senior Solutions Consultant
Alyssa Biller is a Senior Solutions Consultant at Cytel and currently plays a primary role in onboarding customers for...
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August 18, 2021
What does reducing the risk of a faulty conclusion mean: Case study
During the design of a clinical trial, many biotechs want to substantially reduce the risk of a good new therapy being...
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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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July 28, 2021
Lessons Learned from Leveraging Computing Power for Clinical Strategy
“We found an optimal design in hours that might have taken months to find using standard methods,” reflected Fabien...
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July 22, 2021
The Risk of Under-exploring Trial Design Options: A New Case Study
Earlier this year, Cytel founder Cyrus Mehta observed that clinical trial design is often treated like an art rather...
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July 14, 2021
Novel Uses of Scoring Functions in Clinical Trial Design Selection
For decades, statisticians have cultivated methods to optimize and de-risk clinical trials for strong regulatory...
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July 7, 2021
Ensuring You Get Optimal Study Power for Your Investment
Suppose a statistician were to tell a clinical trial sponsor that it was possible to improve the power of the sponsor’s...
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June 30, 2021
Mathematical Methods for Clinical Trial Financial Strategy
When Cyrus Mehta introduced the Promising Zone Design over a decade ago, the new statistical method not only...
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June 23, 2021
Eliminating Underperforming Clinical Trial Designs
Much of the discussion about clinical trial design considers methods to optimize performance characteristics and...
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June 18, 2021
Use of Scoring Functions for Clinical Trial Optimization
Next week’s PSI Conference will feature Dr. Yannis Jemiai speaking on the use of Scoring Functions in the re-imagined...
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June 14, 2021
Practicalities of Integrating Electronic Health Records into Data
ACDM’s (Association for Clinical Data Management) eDigital data management expert group (DMEG) focuses on driving...
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June 9, 2021
Selecting a Clinical Trial Design: How Broadly Should You Explore?
When selecting clinical trial designs, how many design options should a sponsor explore? Would a sponsor feel more...
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June 2, 2021
A Data-Infused Approach to De-Risking Clinical Trials
For many decades the Pareto Frontier has been employed by actors in the private sector to evaluate and understand the...
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May 19, 2021
A Non-Technical Guide to Statistically-Informed Clinical Strategy
Clinical trial sponsors are more likely than ever to use the power of simulation and forecasting to evaluate the...
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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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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...
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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...
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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...
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January 20, 2021
Quantifying Tradeoffs in Clinical Development
One of the most difficult challenges facing Research and Development teams involves determining how to make tradeoffs...
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January 12, 2021
5 Questions to Help You Modernize Clinical Development
The rapid pace of technology has opened up numerous avenues for advanced innovative clinical trial design, but how can...
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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...
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