The Cytel Blog

February 14, 2024

Erika Spens on Developing Your Regulatory Strategy

During drug development, a comprehensive regulatory strategy is key for saving time and money. There are many common...

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February 2, 2024

The Living Model Approach for Systematic Literature Reviews

When building a disease model or an economic model, the assumption has been that updates to such models should only...

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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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January 19, 2024

Accelerated DMC Safety Reports for Biotech’s Central Nervous System Studies: A Case Study

Independent data monitoring committees help to ensure patient safety and uphold trial integrity. In Central Nervous...

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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 27, 2023

The Value of an Optimized Clinical Data Strategy: How Small Changes Can Make a Big Difference

In clinical trials, high-quality data is essential. It drives the drug development decision-making process and is a...

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December 8, 2023

Discussions with the FDA and Ensuring Data Submission Success

Regular technical discussions with the FDA play a critical role in ensuring data submission success. These discussions...

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December 1, 2023

Leveraging Real-World Data for Comparison Using Synthetic Control Arms

Last week, Robert Szulkin, Research Principal, Real World Evidence, discussed the need for real-world evidence studies,...

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November 17, 2023

FSP Behind the Scenes with Nandan Kothavale, Programming Senior Team Lead

Cytel’s Functional Service Provision (FSP) teams work on exciting projects with biotech and pharmaceutical companies as...

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November 6, 2023

Ulrika Andersson on First-in-Human Clinical Trial Development

The first-in-human trial, which aims to show the safety and tolerability of a new drug, is a major milestone for any...

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October 10, 2023

FSP Behind the Scenes with Brooke Smith, Senior Biostatistician

Cytel’s Functional Service Provision (FSP) teams work on exciting projects with biotech and pharmaceutical companies as...

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September 20, 2023

FSP Behind the Scenes with Anwaya Joshi, Programming Senior Team Lead

Cytel’s Functional Service Provision (FSP) teams work on exciting projects with biotech and pharmaceutical companies as...

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September 18, 2023

Cytel Publishes Inaugural Sustainability Report

With the ongoing changes inherent in the life sciences industry comes heightened expectations for companies to take...

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September 8, 2023

Synthetic Control Arms: Leveraging Real-World Data for Comparison in Single-Arm Trials

Single-arm trials, unlike placebo-controlled randomized control trials, forgo the use of a placebo or standard-of-care...

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September 1, 2023

Key Considerations in Planning Your Clinical Data Strategy

Data is the cornerstone of any clinical trial, driving the decision-making process of drug development, and is a...

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August 30, 2023

FSP Behind the Scenes with Jeff Thompson, R Senior Statistical Programmer

Cytel’s Functional Service Provision (FSP) teams work on exciting projects with biotech and pharmaceutical companies as...

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August 25, 2023

Preparing and Concluding Your FDA Data Submission, and More Insights on Data Submission and Data Integration

For several years, CDISC and Regulatory Data Submission expert Angelo Tinazzi has authored the series, The Good Data...

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August 22, 2023

Adaptive Multi-Arm Multi-Stage Designs: A Comparison of Methods

Written by Cyrus Mehta and Heather Struntz The significant time and cost, as well as high failure rates, of clinical...

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August 18, 2023

The Advantages of Forecasting Enrollment with a Model-Based Approach

The most common cause for incomplete Phase III trials is enrollment. Indeed, as many as 37% of trials miss...

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August 11, 2023

Demonstrating Value in Real Time with Living Models for Systematic Literature Reviews

Systematic literature reviews are essential for proving product value to health authorities, clinicians, and payers,...

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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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June 5, 2023

Maria Lundberg on a Holistic Approach to Therapeutics Development

Cytel recently announced the launch of its Therapeutics Development Team, bringing together quantitative,...

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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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April 26, 2023

New Ebook: “The Good Data Doctor on Data Submission and Data Integration”

Regular technical discussions with the FDA play a critical role in ensuring data submission success. These discussions...

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April 11, 2023

Overcoming the Shared Effect Modifier Assumption with Network Meta-Interpolation

Commonly used methods to handle the complexities of effect modification in indirect treatment comparisons (ITCs) often...

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April 5, 2023

Comparative Effectiveness: Methods and Techniques for Better Decision-Making

Health technology assessment (HTA) submissions require cost effectiveness analyses based on comparative effectiveness...

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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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March 13, 2023

Industry Voices: Yannis Jemiai on Simulation-Guided Design and the Changing Landscape of Clinical Trial Strategy

Many industries have long since adopted the practice of modeling and simulating experimental scenarios. And despite...

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March 7, 2023

Can RWE Help Restore Decades of Health Inequalities? Yes, and Here’s How

Health inequalities are an enduring issue that can be exacerbated by clinical trial recruitment that does not reflect...

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March 3, 2023

Multiple Myeloma Research Benefits from Living Model SLR: A Case Study

The speed of scientific discovery has been outpacing the ability of researchers to accumulate and integrate constantly...

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February 24, 2023

Demystifying Synthetic Control Arms

Last week, Cytel Director & Research Principal Louis Dron discussed new FDA guidance on the design and conduct of...

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February 3, 2023

Focal Points and Monetization: New Uses of Pareto Frontiers in Clinical Development

For clinical development and research and development teams, the Pareto Frontier can perform two functions. Let’s take...

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January 31, 2023

Linked Data Studies: Improving the Way We Do Observational Research in Germany

Asthma affects more than 235 million people worldwide, and due to lacking effective implementation of clinical...

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January 27, 2023

To Adapt or Not to Adapt? A Decision Framework

Should your clinical trial be adaptive? Trials that include a prospectively planned modification based on an interim...

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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 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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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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December 29, 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 19, 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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December 14, 2022

Accrual When Starting a Platform Trial vs. in a Stand-Alone Trial

When evaluating the efficacy of a candidate investigational therapy, a standard clinical trial paradigm is to conduct a...

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December 2, 2022

Celebrating 35 Years of Innovation and Impact: An Interview Series

For 35 years, Cytel’s scientific rigor and operational excellence have enabled biotech and pharmaceutical companies to...

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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 14, 2022

Network Meta-Interpolation: Effect Modification Adjustment in Network Meta-Analysis Using Subgroup Analyses

When conducting network meta-analysis (NMA) – that is, a technique that involves comparing multiple treatments...

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November 3, 2022

Cytel at ISPOR Europe: Two Workshops

Cytel will be represented at over 60 presentations at ISPOR Europe 2022, with more issue panels and workshops than any...

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October 27, 2022

The Need for a “Living” Approach to HTAs

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October 21, 2022

Balancing Real-World Data Quality vs. Locality in Supporting Single-Arm HTA Submissions

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October 20, 2022

The Need for Structured Tools to Guide HTA Submissions

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October 13, 2022

Cytel at ISPOR Europe: Top Presenter of Issue Panels and Workshops

ISPOR Europe, the leading global conference for health economics and outcomes research (HEOR) and real-world evidence...

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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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September 28, 2022

Statistical Leaders and the Future of Drug Development

The landscape of drug development has changed dramatically over the last few decades, and effective statistical leaders...

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September 23, 2022

Adaptive Trials at the Mainstream of Drug Development

Adaptive trial designs – that is, trials that include a prospectively planned modification based on an interim analysis...

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September 15, 2022

U.S. Drug Pricing Reform: Potential Impact on Pharma HEOR Evidence Generation

On August 16, 2022, President Biden signed into law the Inflation Reduction Act of 2022, which includes U.S. drug...

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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 8, 2022

Cytel Present at the ASA Biopharmaceutical Section Regulatory Workshop

The American Statistical Association Biopharmaceutical Section, in cooperation with the FDA Statistical Association,...

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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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August 25, 2022

Cytel Presents at ICPE 2022

The International Society for Pharmacoepidemiology is hosting its “ICPE 2022: Advancing Pharmacoepidemiology and...

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August 19, 2022

The Good Data Doctor on Data Submission and Data Integration

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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 12, 2022

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