Perspectives on Enquiry & Evidence
Cytel's blog featuring the latest industry insights.
April 22, 2024
Written by Boaz N. Adler, Director, Global Product Engagement, and J. Kyle Wathen, Vice President, Scientific Strategy...
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April 17, 2024
Early Planning Strategies for External Control Arms in HTA and Regulatory Submissions
Written by Grace Hsu, Evie Merinopoulou, and Jason Simeone To establish treatment efficacy and safety, regulatory and...
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April 15, 2024
Data-Centric Approaches to Streamline the Clinical Workload
In the context of clinical trials, reducing the workload of the clinical team without compromising data quality is...
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April 10, 2024
Orphan Drug Designation for Rare Diseases
Orphan drug designation is a regulatory status granted to pharmaceuticals developed for the treatment of rare diseases....
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April 3, 2024
Developing a New Drug Candidate: From Nonclinical to First-in-Human
Thank you to Charlotta Gauffin, Chief Scientific Officer at Dicot, for joining us for our recent webinar, “The Road to...
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April 2, 2024
The FDA’s New Draft Guidance on DMCs: What to Know
Data monitoring committees (DMCs) review ongoing clinical trial data to make recommendations regarding trial conduct...
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March 11, 2024
Quantitative Strategies for Rare Disease Clinical Trials
In 2023, rare diseases accounted for 30% of product pipeline under development, about half of which comprising...
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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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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 13, 2024
Strategies to Overcome Limited Patient Population Challenges in Rare Disease Studies
Written by Boaz N. Adler, MPA, Director, Global Product Engagement, and Valeria Mazzanti, MPH, Associate Director,...
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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 22, 2024
How to Save Time and Limit Costs toward First-in-Human Clinical Trials
Regulatory guidelines outline all crucial studies and documentation that should be in place before a drug product can...
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January 17, 2024
Late-Stage Clinical Development Strategy: Trade-Offs and Decision-Making in the Confirmatory Setting
Despite accumulating learnings from early phases, several uncertainties remain to be addressed when designing pivotal...
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January 15, 2024
Navigating the Clinical Development Landscape: Insights for Success in 2024
After explosive and frenetic activity in the clinical trial industry during the COVID era, the past two years have seen...
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January 10, 2024
Optimizing Early Clinical Development Strategy
A clinical development strategy is a comprehensive plan designed to establish the safety and efficacy of new...
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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
Top Data Submission and Data Integration Posts of 2023
Perspectives covers a wide range of topics related to data submission and data integration, from ISS and ISE best...
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December 22, 2023
Top Therapeutics Development Topics of 2023
Perspectives covers a wide range of topics within therapeutics development from advice on regulatory submission to...
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December 20, 2023
Top Real-World Evidence and Real-World Data Topics of 2023
Perspectives covers a wide range of topics related to real-world evidence and real-world data, from overcoming health...
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December 6, 2023
Drug Manufacturer Auditing: Ensuring Quality, Control, and Safety
Chemistry, Manufacturing, and Controls (CMC) is a critical component of drug product development. As a Senior...
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December 4, 2023
Preserving Trial Integrity After Receiving an Unanticipated IDMC Recommendation
Independent data monitoring committees review unblinded clinical trial data and issue recommendations to designated...
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November 29, 2023
Don’t Forget the Development of Your Placebo: Overcoming Common Obstacles
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 24, 2023
Epidemiological Methods to Tackle Real-World Evidence Challenges
Regulatory requirements regarding documentation for new medicines are constantly evolving. Previously, randomized...
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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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November 10, 2023
Conduct of IDMCs for Cell and Gene Therapy Trials
Independent data monitoring committees review unblinded clinical trial data and issue recommendations to designated...
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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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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 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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October 27, 2023
News from ESMO: Challenging the Status Quo of Early Phase Clinical Trial Design — Moving from “Why” to “How”
Written by Natalia Muehlemann, Vice President, Clinical Development; Martin Frenzel, Research Principal, Statistical...
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October 13, 2023
Looking to the Future — Improving Diagnosis and Prognosis of Eye Conditions with Artificial Intelligence
Written by Alind Gupta, Cytel; Haridarshan Patel, Horizon Therapeutics; and Jason Simeone, Cytel Ophthalmology is...
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October 11, 2023
Global Planning to Local Execution Market Success
Moving beyond static evidence development to ensure local market access success; responding to recent changes in...
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October 6, 2023
Writing a Successful Study Protocol for Real-World Evidence Studies
Real-world evidence studies are becoming increasingly popular in pharmaceutical development. But to ensure such studies...
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October 4, 2023
How to Ensure Your Adaptive Trial Is Appropriate for Regulatory Submission
Adaptive clinical trial designs have become increasingly popular among developers and investors due to the many...
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September 25, 2023
Reducing Independent Data Monitoring Committee Timelines: A Focus on Formal Interim Analyses
As the pressure to reduce timelines rises across the industry, independent data monitoring committees (IDMCs) — which...
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September 13, 2023
Setting Expectations for Formal Interim Analyses with Independent Data Monitoring Committees
Independent data monitoring committees (IDMCs) review ongoing clinical trial data to make recommendations regarding...
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September 11, 2023
How to Ask the Right Questions at an Authority Meeting
As a drug developer, you have to live with the answers and comments you get from regulatory authorities. Therefore,...
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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 28, 2023
How to Create and Optimize a Clinical Development Plan
A clinical development plan — a comprehensive strategy for developing an investigational product through regulatory...
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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 20, 2023
New FDA Guidelines on Pediatric Studies and Potential Effects on Opportunities for Market Exclusivity
Legislation on pediatric studies has existed for more than 20 years in the US, yet additional guidance from the FDA has...
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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 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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April 14, 2023
Data Challenges (and Solutions) for Externally Controlled Trials
Real-world data and evidence are increasingly being used in health care decisions and publications. However, there are...
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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 21, 2023
Retrospective Claims Data Analysis Unlocks Discovery in Multiple Sclerosis Research
One of the lesser-known complications associated with Multiple Sclerosis is a higher risk of serious infections (SIs)....
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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 8, 2023
New Linked Database Expands Potential of RWE: A Unique Opportunity for Multiple Sclerosis Research
Real-world data has been increasingly used to answer questions related to the course, prognosis, and treatment of...
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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 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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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 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 25, 2023
Bayesian Approach in Oncology Trials
People think in Bayesian terms all the time: we use prior information and the evidence at hand to make decisions in our...
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January 23, 2023
Design Considerations for Early Phase Trials of Immuno-oncology Drugs
Ever since the first immune checkpoint inhibitor was approved for market nearly twelve years ago, the industry has...
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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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January 4, 2023
A Look Ahead for 2023
Returning to Cytel after the winter holidays, I am excited to begin a year that will likely prove memorable for both my...
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December 29, 2022
Top Perspectives Articles of 2022
Perspectives on Enquiry and Evidence explores a wide variety of topics within clinical trial design and data science in...
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December 27, 2022
Top Bayesian Topics of 2022
Bayesian methods have been playing a key role in transforming clinical research, providing a variety of new...
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December 21, 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
Top Adaptive Clinical Trial Topics of 2022
Adaptive trial designs – that is, trials that include a prospectively planned modification based on an interim analysis...
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December 16, 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 29, 2022
Bayesian Adaptive Clinical Trial Designs: INLA vs. MCMC
Bayesian methods have continuously played a key role in transforming clinical research in therapeutic areas such as...
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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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November 2, 2022
Bayesian Hierarchical Modelling for Histology-Independent Therapies
Pharmaceutical research in oncology is increasingly focused on the development of therapies targeted at newly...
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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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October 24, 2022
Cyrus Mehta on the Founding of Cytel
On the occasion of Cytel’s 35th anniversary, co-founder Professor Cyrus Mehta sits down with Dr. Esha Senchaudhuri to...
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October 18, 2022
Nitin Patel on 35 Years of Technological Innovation
On the occasion of Cytel’s 35th anniversary, co-founder Professor Nitin Patel sits down with Dr. Esha Senchaudhuri to...
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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 11, 2022
Joshua Schultz on the Evolution of Cytel
On the occasion of Cytel’s 35th anniversary, our CEO Joshua Schultz sits down with Dr. Esha Senchaudhuri to discuss the...
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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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October 3, 2022
Bayesian Methods for Historical Borrowing: Conjugate Priors
The wider availability of electronic health data, medical registries, and even larger proprietary datasets means that...
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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 27, 2022
Data Capture and Data Sharing During the COVID-19 Pandemic
On Louis Dron et al., “Data Capture and Sharing in the COVID-19 Pandemic: A Cause for Concern,” The Lancet 4 (10) (2022)
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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 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 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 3, 2022
The Uses of Bayesian Methods in Late-Phase Clinical Trial Strategy
A number of late-phase clinical trial sponsors remain hesitant to employ Bayesian approaches in confirmatory settings,...
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July 28, 2022
New Directions in Indirect Treatment Comparisons
When new treatments are compared with existing therapies in clinical care, population-adjustment techniques need to...
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July 27, 2022
Adaptive Designs Are Re-Defining Drug Development – Learn What's New
Written by Jing Ping Yeo and Charles Warne Adaptive designs are studies that “include a prospectively planned...
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July 26, 2022
7 Ways RWD Is Transforming Clinical Research
To watch this webinar and others from this introductory series, click the link below. The ability to draw on electronic...
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July 20, 2022
The Case for Network Meta-Interpolation to Handle Effect Modifiers in Indirect Treatment Comparisons
When performing indirect treatment comparisons, effect modification can create complexities in the event of high...
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July 13, 2022
5 Steps to Adjust for Effect Modifiers for Treatment Comparisons
Many thanks to Grammati Sarri and Michael Groff for their comments in developing this blog. An indirect treatment...
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July 12, 2022
Strategies for Selecting New Indications for a Platform Trial
Thanks to Dr. Kyle Wathen for comments on this blog. The increasing use of platform trials for the testing of a wide...
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July 7, 2022
Using Quantitative Bias Analysis in Real World Data Strategy
The gold standard for assessing the efficacy for a medicine continues to be RCTs, however, for many reasons (disease...
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June 29, 2022
Platform Trials, Master Protocols, and Challenges in Execution
How can we build an efficient statistical protocol for a clinical trial, if we do not know the therapies that will be...
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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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February 4, 2022
WINTER WEEKEND READ: Model-Based Enrollment Forecasting
The ability to conduct data-driven and quantitatively rigorous feasibility studies, is often key to successful trial...
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February 2, 2022
How to Overcome Common Challenges to Patient Recruitment Projections
For nearly ten years, suboptimal trial enrollment has been cited as a primary cause of clinical trial discontinuation....
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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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October 6, 2021
The Rapidly Evolving Need for Master Protocols
Master Protocols are advanced and innovative clinical trial designs that can evaluate multiple therapies and disease...
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October 1, 2021
Dr. Kyle Wathen talks about the Need for Statistical Innovation
The COVID-19 pandemic elevated the challenge of designing and executing clinical trials within a substantially...
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September 29, 2021
How to leverage model-informed drug development for rare diseases
While there is a plethora of rare diseases, some 7000 diseases and counting, one needs to consider the statutory...
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September 24, 2021
ICT Magazine Interviews Dr. Yannis Jemiai on the Benefits of Bayesian
We may be familiar with adaptive designs, but their complexity has made them difficult to implement and their benefits...
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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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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 13, 2021
Finding the Optimal Trial Design Using Operations Research Methods
With the cloud computing power that we have today, we can run simulation of 1000s of designs with each design...
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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 27, 2021
Thinking of Clinical Development from a Bayesian Lens
Program and portfolio optimization creates a framework throughout the course of the clinical development journey, that...
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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 12, 2021
Using Confidence Distributions to Manage Statistical Heterogeneity
Medical researchers and public health experts are becoming more reliant on meta-analyses to capture in summary form,...
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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 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 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 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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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 14, 2021
Starting the Conversation Early: Incorporating Business Considerations in Optimal Selection of Trial Design
When developing clinical strategy, applying familiar business principles to the specific requirements of clinical...
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May 12, 2021
Strategic Insights from Novel Bayesian Methods – Complimentary Paper
Did you know that Bayesian methods can strengthen Frequentist trials through the use of Bayesian decision criteria or...
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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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April 28, 2021
Trial Selection: From Art to Science
Recently, Cytel co-founder Professor Cyrus Mehta noted that, “Clinical trial design selection is too much like an art,...
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April 20, 2021
New Dimensions of Clinical Trial Optimization
For much of the past three decades, even as methodologies for clinical trial design have advanced and refined, the idea...
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March 26, 2021
Using External Evidence for Decision-Making for Medical Devices
Former Commissioner of the FDA, Dr. Scott Gottlieb, in several public presentations, would bemoan missed chances to...
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March 19, 2021
5 Steps to Regulatory Success with Wearables Designs
The use of wearable and digital technology requires considerations for both drugs and devices regulations, and...
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March 18, 2021
Computing & Statistics: Are You Ready for the Industry Transformation?
Over the past ten years High-Performance Computing (HPC) has transformed medical research through advances in genomics,...
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March 12, 2021
Wearables: Translating raw data to actionable information
With wearables likely to become a regular part of clinical trial design, statisticians could benefit by familiarizing...
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March 11, 2021
Data and analysis in Modern Oncology Clinical Development
In the recent years, Oncology trials are seeing a technological shift that is expected to make them faster and more...
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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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March 5, 2021
Single Arm Multi-Stage Phase 2 Cancer Trials
Early stage Phase 2 clinical trials are often designed as multi-stage single arm trials, which quickly identify...
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February 26, 2021
Empowering Statisticians to Create Complex Bayesian Clinical Study Designs
In the world of clinical trials, the pace of innovation is accelerating, and approaches such as Bayesian methods are...
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February 25, 2021
Use of Wearables in Confirmatory Clinical Trials
The convergence of several distinct trends has made wearables an increasingly attractive option for use in confirmatory...
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February 19, 2021
Selecting Your Next Clinical Trial Design Using Quantitative Methods
C-Suite and R&D Decision-Makers are always striving to make evidence-driven decisions. Yet the rules by which evidence...
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February 18, 2021
Introduction to Evidence Synthesis and Bayesian dynamic borrowing
In the last few years, there has been a growing interest in historical borrowing or augmented trials. There is an...
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February 17, 2021
An Interview with Louis Dron on the Benefits and Future of Cytel’s Trial Tracker
The COVID-19 Pandemic prompted the rapid surge in the generation of clinical data that has been scattered across...
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February 11, 2021
The biostats and clinical overview of a growing clinical strategy
The past two years have witnessed a heightened interest in the use of wearables in clinical development. The unexpected...
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February 9, 2021
New Meta-Analysis in JAMA Uses Novel Quantitative Techniques to Demonstrate Baseline Characteristics Informing Response to Common Therapy for Kidney Cancer
Recent years have witnessed improving survival outcomes for those struggling with a range of common kidney cancers....
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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 22, 2021
The Role of Real World Evidence after COVID19
COVID-19 has transformed the pharmaceutical industry in a manner that few could have predicted only a year ago. One of...
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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 19, 2021
Cytel COVID Panel: Long-term Changes to Clinical Trials Due to the Pandemic
As we enter 2021 with new COVID-19 vaccines and greater optimism about the pipeline of drugs and devices positioned for...
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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 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...
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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...
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December 3, 2020
New Whitepaper: Reimagining Clinical-Trials
Increasing Clinical Development Productivity Using Statistics and Cloud-Computing The need for Re-imagining Clinical...
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November 24, 2020
Cytel and Ingress Health at Virtual ISPOR Europe 2020
Virtual ISPOR 2020, held November 16 to 19, presented new opportunities for scientific interaction amongst HEOR...
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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....
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November 12, 2020
Join Cytel and Ingress Health at Virtual ISPOR Europe 2020
Cytel and Ingress Health (now a Cytel company) will be contributing to a range of events at Virtual ISPOR EUROPE 2020,...
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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,...
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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...
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November 2, 2020
Value of Detailed Clinical Trial Simulations for Rare Diseases
Measuring treatment effect during a clinical trial is often the source of much debate, particularly during rare disease...
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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...
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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...
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October 23, 2020
Yuan Ji on U-Design: An All New Efficacy and Toxicity Dose-Finding Module
Cytel’s New Horizons Webinar Series introduces you to the latest innovations in statistical trial design. This webinar...
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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...
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October 19, 2020
The Uniqueness of COVID-19 Data Challenges; The COVID-19 trial tracker
COVID-19 has created extreme uncertainties -- a dearth of historical information combined with the need for safety,...
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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,...
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October 13, 2020
Introducing Observational Studies – Three Trends for Statisticians
The combination of greater access to electronic health records, bigger electronic claims datasets, and the need for...
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October 9, 2020
Cyrus Mehta on Increasing the Power of Platform Trials
Even before the era of COVID-19, significant attention was channeled to the overwhelming potential of adaptive MAMS...
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October 7, 2020
RWE Needs for Natural History Studies
With the rise in digital technologies, there has been an explosion in the volume and type of data sources. We can...
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September 25, 2020
Use of External Controls in Clinical Development – Download Audiobook
Regulators in both the United States and Europe have responded positively to the use of synthetic control arms (SCA)s...
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July 30, 2020
Cytel Scientists Call for a “Statistician-First Workflow” to Optimize Drug Development
A new peer-reviewed article co-authored by several Cytel scientists re-examines the way in which adaptive trials are...
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June 4, 2020
COVID-19 Weekly Brief
This weekly snapshot gives you a quick briefing on the state of COVID-19 therapy and vaccines development. As we head...
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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...
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August 23, 2019
Advancing Medicines Development with External Controls
In place of collecting data from patients recruited for a trial who have been assigned to the control or...
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August 14, 2019
Keeping Clinical Trials on Track: A Statistician's Perspective
This article was originally published as part of a series by pharmaphorum in association with Cytel and is reproduced...
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August 1, 2019
Predictive Biomarker Signature Characterization
The term biomarker signature describes the behavior of a set of biomarkers that define a signature to maximize the...
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July 8, 2019
Estimands are not just a statistical issue- Q&As and webinar replay
Cytel recently hosted a very well-attended and engaging webinar on the topic of “Estimands, not just a statistical...
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June 27, 2019
Handling the specialized data requirements in oncology clinical trials
By Nicolas Rouillé and Eric Henniger The right design and the right data ultimately leads to the right decisions, so...
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June 14, 2019
Flipping the paradigm-how should biotechs harness adaptive trials?
This article was originally published as part of a series by pharmaphorum in association with Cytel and is reproduced...
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April 24, 2019
Assuring Outsourcing Obligations with Specialist Data Management Oversight
In this blog, Alla Muchnik, Senior Clinical Data Manager at Cytel, discusses how specialist CROs can add value and...
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April 10, 2019
Ensuring Robust ePRO Implementation: Factors for Success
In this blog, Jonathan Pritchard, Director Business Development at Cytel, draws on his experience in commercial,...
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March 15, 2019
Strategic Applications of Pharmacometrics in Clinical Development
Quantitative pharmacology encompasses the many strategic advantages of using complex mathematical models to understand...
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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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June 19, 2018
The Importance of Standardization in Clinical Outsourcing
At the recent PCMG conference in Malta, Adrian Otte ( Independent Consultant, formerly VP Global Development Operations...
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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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November 28, 2017
Interview: Clinical Trial Optimization with R
In this blog we turn to some reading matter, and interview Gautier Paux and Alex Dmitrienko about the recent book...
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November 9, 2017
The Cytel Story: In the Co-Founders' Own Words
In this blog we are excited to unveil a new project which we have been hard at work on over the last few months. 2017...
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November 6, 2017
Asking the Right Questions of Your Data: Experiences in Model Informed Drug Development
At the Chief Medical Officer Summit earlier this year, Cytel's Director of Quantitative Pharmacology and...
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September 29, 2017
Career Perspectives: Interview with Namrata Deshpande, Senior Team Lead
Namrata Deshpande, Senior Team Lead will be participating in a round table discussion at the Women in Statistics event...
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September 13, 2017
How can Novel Statistical Methods Tackle Antibiotic Resistance?
Antibiotic resistance is one of the greatest challenges facing human health today. We are excited to welcome Dr. Scott...
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September 11, 2017
Design Concept for Basket Trials: Interview with Bob Beckman
At the East User Group meeting (EUGM) on 25th and 26th October, we will welcome a number of renowned industry speakers...
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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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June 8, 2017
Measuring Intergroup Agreement and Disagreement
Cytel's Madhusmita Panda presented at this year’s PSI Conference in the Innovative Methodology session on the topic of...
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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...
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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...
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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...
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October 11, 2016
Simulations to optimize clinical trial programs
Its important to take a strategic approach to clinical development in order to minimize the potential for Phase 3...
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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....
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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...
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September 27, 2016
Practical Challenges of the LUNG-MAP study
The Lung-MAP trial is an innovative biomarker driven 'precision medicine' study which evaluates five novel agents for...
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September 20, 2016
An efficient tool for model based meta-analysis
Drug development is an expensive and risky business. To maximize a compound’s ultimate chances of commercial as well as...
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June 23, 2016
Getting the best out of your biometrics RFP
Vendor selection is a critical component of ensuring clinical trial success. A 2015 report (1) suggested that clinical...
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June 7, 2016
How can the CMO/Biostatistician connection improve clinical development?
At the recent CMO Summit East James ( Jim) Bolognese, Cytel’s Senior Director of Strategic Consulting, and Lou...
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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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November 5, 2015
The 24 Hour Work Day
Oftentimes people perceive a tradeoff between speed and quality. The faster you do something the more likely you are to...
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September 29, 2015
5 Skills Needed by All Highly Effective Statisticians
The Head of the DIA’s Adaptive Design Working Group Asks Us to Consider 5 ‘Soft-Skills’ All Effective Statisticians...
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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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June 11, 2015
Aligning Clinical Development & Regulatory Objectives for Cardiovascular Outcome Trials
When the FDA first began to require pharmaceuticals to perform cardiovascular outcome trials to establish the safety of...
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May 28, 2015
How to Use Outsourcing to Reduce Clinical Development Risk
Risks in drug development range from taking the wrong drugs forward to Phase 3 to investing in a drug development...
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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 30, 2015
New Articles on Adaptive Clinical Trials & Adaptive Financing
Adaptive financing (not to be confused with adaptive licensing) explores how biotechs, pharmaceuticals and potential...
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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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April 21, 2015
Adaptive SSR for Small Sample Sizes?
“We shouldn’t use an adaptive design, our sample size is too small.” Most clinical trial planners have heard this line...
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April 9, 2015
Relative Clinical Efficiency and Phase 2 Biomarker Studies
Last year. Nature Reviews Drug Discovery asked the FDA’s Tatiana Prowell (Hematology & Oncology Products Division)...
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April 2, 2015
Monte Carlo Simulations II: Reassessing Strategic Options During an Interim Look
Midway through a trial is a terrible time to realize that you need a new strategy to complete the study. Sadly, it is...
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March 27, 2015
Leveraging the Flexibility of an Adaptive Clinical Trials: A Case Study
We have often said that one of the greatest benefits of an adaptive clinical trial is the flexibility it affords for...
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February 12, 2015
Data-Driven Trial Planning: An Interview with Pfizer's Chris Conklin
Data driven decision-making can ensure that every feasibility team achieves its enrollment milestones. By transforming...
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February 10, 2015
How to Shorten a Cardiovascular Outcome Trial By Two Years
Cardiovascular outcome trials (CVOTs) have earned the reputation of being the untamable behemoths of the clinical...
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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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January 13, 2015
Simulation and Prediction for Adaptive Licensing Decision-Making
Janus was the Roman God of transitions, a deity with two faces, one looking towards the past and the other the future....
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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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December 16, 2014
Cultivating Versatility in Statistical Consultants
Richard Branson once wrote: “I have always valued capability over expertise. While you may need to hire specialists for...
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December 11, 2014
Adaptive Designs for Infectious Diseases Clinical Development Strategy
A common framework for the clinical development of vaccines involves the study of several candidate compounds in Phase...
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