Perspectives on Enquiry & Evidence

Cytel's blog featuring the latest industry insights.

Featured post

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, it’s essential that you choose your questions carefully and avoid questions you don’t need answers to. Here we take a closer look at how to approach these meetings.

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Perspectives on Enquiry and Evidence

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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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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April 21, 2022

Bayesian Statistics and Its Applications: New Webinar by Professor Yuan Ji

Sophisticated Bayesian Methods are gaining a lot of traction as they bring flexibility and speed to clinical trial...

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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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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 2, 2021

Bayesian Methods for Master Protocols

As the use of master protocols becomes more prevalent in drug development, Bayesian methods are extensively used to...

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November 17, 2020

Role of Prediction and Causal Inference in Clinical Research

As a part of Cytel’s "New Horizons Webinar Series", Alind Gupta, Senior Data Scientist, presents case studies from his...

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November 10, 2020

Key Design Considerations for Platform Trials

Platform trials are a new type of clinical trials where multiple interventions can be evaluated simultaneously against...

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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 27, 2020

Bayesian Dose-Finding Designs – An Overview

Cytel recently conducted a webinar on Bayesian Dose-finding Designs for Modern Drug Development, presented by Dr. Yuan...

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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 12, 2020

Bayesian Statistics and FDA Regulatory Acceptability

Cytel and Novartis are together hosting a complimentary Bayesian Virtual Symposium and an Interactive 7-part workshop....

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September 30, 2020

A Virtual Event Brought to you by Cytel and Novartis on Innovations

Today, there is a need for advanced quantitative techniques to combine all available information for better decision...

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September 29, 2020

The New Horizons Series: Adaptive Multi-arm Multi-stage Clinical Trials

Innovation in trial designs are offering new routes forward for organizations of any size. They are now also aligned...

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September 15, 2020

Accurately analyze small, skewed or sparse data with StatXact

In clinical trials with small or sparse data, statistical methods meant for large sample sizes may not be helpful to...

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September 9, 2020

Importance of Designing Clinical Trials from a Program Perspective

Cytel’s co-founder, Nitin Patel, conducted a webinar on designing clinical trials from a program-level perspective. His...

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August 31, 2020

Adopt innovative and computationally intensive designs with East Alloy

Pantelis Vlachos, Principal, Strategic Consultant at Cytel, conducted a webinar to introduce the capabilities of East...

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August 25, 2020

Nitin Patel on Designing Clinical Trials from a Program Perspective

It is important to take a strategic approach to clinical development in order to minimize the potential for Phase 3...

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August 19, 2020

Webinar on Adaptive Designs for Dose Finding: Part 2

Bjoern Bornkamp, Statistical Methodologist at Novartis and Jose Pinheiro, Senior Director, Johnson & Johnson provided...

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August 13, 2020

Webinar: Adaptive Designs for Dose Finding

Bjoern Bornkamp, Statistical Methodologist at Novartis and Jose Pinheiro, Senior Director, Johnson & Johnson provided...

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July 27, 2020

Introduction to Population Enrichment by Dr. Thomas Burnett

Cytel is conducting a webinar series on complex innovative trial designs. Dr. Thomas Burnett, Senior Research Associate...

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July 15, 2020

Three Reasons Why Oncology Trials Need Clear Estimands

Unlike many therapeutic areas, oncology benefits from having standardized endpoints like overall survival and...

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July 13, 2020

Interview with Dr. Thomas Burnett on Adaptive Enrichment

Cytel is hosting a complimentary webinar series that introduces biostatisticians and other members of the development...

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May 12, 2020

Oncology Trial Design & Development Webinar Series

In our previous blog, “Remote Working Arrangement – How to get it right?”, we talked about how the need for social...

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May 7, 2020

COVID-19: Trials, Designs and Tools for Promising Results - A Virtual Panel Discussion

An extraordinary amount of global research is underway as the COVID-19 pandemic continues to evolve and spread...

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May 5, 2020

Webinar: A Clinician’s Perspective on Cancer Drugs Development

Cytel's team of oncology trial design and advanced analytics experts are hosting a series of complimentary webinars...

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April 29, 2020

Webinar: Transparent Machine Learning in Oncology

In our previous blog, we spoke with Alind Gupta, who works as a Machine Learning Researcher at Cytel in Canada. The...

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April 23, 2020

A Clinician’s Perspective on Cancer Drugs Development

Cytel is hosting a webinar, “A Clinician’s Perspective on Cancer Drugs Development”, on April 28, 2020. Our speaker,...

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April 20, 2020

Interview with Alind Gupta: Transparent Machine Learning in Oncology

Cytel is hosting a webinar on Transparent Machine Learning in Oncology, on April 21, 2020. Our speaker, Alind Gupta,...

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March 31, 2020

Key Design Thoughts for Basket Trials and Umbrella Trials by Jay Park

Since 1953, when the discovery of the structure of DNA was made, we have seen great advancements in genomics....

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March 12, 2020

Interview with Jay Park: The present and future of Master Protocols

In September 2018, the FDA provided a draft guidance on master protocols reflecting an increased interest in these...

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December 5, 2019

Biotechs and Medtechs, don’t forget your market access strategy (part 4 of 4): How to optimize your market access planning approach

Author: Michael S. Paas, Market Access & Commercialization Expert, Executive at AbbVie and Guest Author at Cytel In...

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