The Cytel blog keeps you up to speed with the latest developments in biostatistics and clinical biometrics.

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

September 29, 2020

Innovation in trial designs are offering new routes forward for organizations of any size. They are now also aligned with the overarching goals of improved clinical development, better pre-planning, greater patient safety, less medical waste, and/or increased knowledge.

Cytel is hosting "New Horizons Webinar Series" that will introduce biostatisticians to the latest innovations in statistical trial design. The first webinar in the series on Adaptive Multi-arm Multi-stage Clinical Trials is going to be presented by Cytel's President & Co-Founder, Cyrus Mehta. Click on the button to register.

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Accurately analyze small, skewed or sparse data with StatXact

September 15, 2020

In clinical trials with small or sparse data, statistical methods meant for large sample sizes may not be helpful to get an accurate interpretation of data. This is where computationally challenging exact methods often come into play. Chris Corcoran, David B. Haight Professor of Analytics in the Huntsman School of Business, is presenting at a Cytel webinar where he will introduce some basic exact statistical procedures provided in Cytel’s StatXact®. The software offers more than 160 tests and procedures for exact inference and power analysis.

Join Chris Corcoran in this example-based discussion where he will illustrate why exact analysis can be crucial in providing accurate results in some very common settings, particularly those involving small or sparse samples. Click on the button to register for the webinar.

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Importance of Designing Clinical Trials from a Program Perspective

September 9, 2020

Cytel’s co-founder, Nitin Patel, conducted a webinar on designing clinical trials from a program-level perspective. His presentation helps us understand the value of designing clinical trials considering downstream consequences. Watch the on demand webinar to get insights on the role of simulation in optimizing clinical trials' performance from a program perspective and understanding the hybrid Bayesian-frequentist approach to clinical trial design.

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We also had the opportunity to interview Nitin about his journey since he co-founded Cytel and got his views on implementing a program-wide strategy for pharma and biotech companies. Read the blog here.

Continue reading this blog for key highlights from the webinar.

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Adopt innovative and computationally intensive designs with East Alloy

August 31, 2020

Pantelis Vlachos, Principal, Strategic Consultant at Cytel, conducted a webinar to introduce the capabilities of East AlloyTM. East Alloy is a new East environment that enables rapid access to innovation with the trust and support you have come to expect from Cytel. The cloud-native software makes it practical to apply computationally intensive Bayesian methods.

This blog is a part of the new blog series on technology and Bayesian decision-making by Pantelis. Continue reading to learn about the methods and capabilities, such as, Bayesian meta-analytic priors, Bayesian MAMS, adaptive dose-finding and others, available to all East Alloy users. Click the button to access the on demand webinar.

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Nitin Patel on Designing Clinical Trials from a Program Perspective

August 25, 2020

It is important to take a strategic approach to clinical development in order to minimize the potential for Phase 3 attrition. In our next webinar from the ‘Introduction to Complex Innovative Trial Design’ webinar series, Nitin Patel, co-founder of Cytel, will provide an overview of the concepts of program optimization. As a case study, we will describe a Phase 2 trial design based on program-level optimization. We utilize a hybrid Bayesian-frequentist framework to evaluate the impact of Phase 2 design choices on the probability of Phase 3 success, clinical utility, time to market, trial costs and expected net present value (ENPV) of the product. These factors include Phase 2 sample size, dose selection and go-no go decision rules for Phase 3, and Phase 3 sample size. 

Click the button to register for the webinar on August 26, 2020.

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In this blog, we talk to Nitin about his journey since co-founding Cytel; and gain insights on program optimization, the challenges for both big and small pharmaceutical/biotech companies, and how to go about the planning process.

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Webinar on Adaptive Designs for Dose Finding: Part 2

August 19, 2020

Bjoern Bornkamp, Statistical Methodologist at Novartis and Jose Pinheiro, Senior Director, Johnson & Johnson provided their insights on adaptive designs for dose finding in Cytel’s latest webinar. The webinar demonstrates how adaptive and Bayesian techniques can be implemented for optimal dose-finding.

This two-part blog series provides a summary of the webinar. Read the first part to get key highlights from the presentation by Jose Pinheiro on the need to conduct dose finding Phase 2 studies, dose selection comparisons and the use of MCP-Mod for dose finding. 

Continue reading this second part to learn about the methods of adaptive dose-finding, presented by Bjoern. Click the button to access the webinar recording and download the presentation slides

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Webinar: Adaptive Designs for Dose Finding

August 13, 2020

Bjoern Bornkamp, Statistical Methodologist at Novartis and Jose Pinheiro, Senior Director, Johnson & Johnson provided their insights on adaptive designs for dose finding in Cytel’s latest webinar. Finding the right dose in Phase 2 gives a potential new therapy its best chance to demonstrate efficacy during Phase 3. A well-executed dose-ranging trial therefore has the potential to alter the course of the entire clinical development program. This webinar demonstrates how adaptive and Bayesian techniques can be implemented for optimal dose-finding.

This two-part blog series will provide a summary of the webinar. In this first part, get key highlights from the presentation by Jose Pinheiro on the need to conduct dose finding Phase 2 studies, dose selection comparisons and the use of MCP-Mod for dose finding. Click the button to access the webinar recording and download the presentation slides

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Introduction to Population Enrichment by Dr. Thomas Burnett

July 27, 2020

Cytel is conducting a webinar series on complex innovative trial designs. Dr. Thomas Burnett, Senior Research Associate in Medical and Pharmaceutical Statistics at Lancaster University, joined us as the presenter in the latest webinar from this series. In this webinar, “Adaptive Enrichment Designs in Clinical Development”, Dr. Burnett provides us a brief introduction to population enrichment and explains where it fits in clinical trials. He offers his insights on the topics of hypothesis testing and decision making, which is a key component of adaptive designs. You can also learn about a real-world case study (TAPPAS Trial) where this approach was used. Continue reading this blog for highlights from the webinar.

Watch the webinar recording and download the slides by clicking the button.

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Read an interview with Dr. Thomas Burnett on adaptive enrichment.

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Three Reasons Why Oncology Trials Need Clear Estimands

July 15, 2020

Unlike many therapeutic areas, oncology benefits from having standardized endpoints like overall survival and progression-free survival, as well as standardized methods of measuring such endpoints. Given that the purpose of an Estimands Framework is ostensibly to streamline scientific questions with specific targets of estimation, what is the benefit of an Estimands Framework for oncology?

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