Cytel Blog

In recent times, Single arm trials are being increasingly used to assess new treatment interventions. They establish clinical benefit by demonstrating the effects of a new therapy or treatment, without the need to use placebo or standard of care as a control. Instead, an alternative approach known as external controls or synthetic control arms (SCA) are being used that leverages real world data and historical datasets. Technical knowledge of Bayesian methods is key to being able to design and implement such trials.

Breakthrough treatments in oncology and rare diseases are now commonly approved based on a pivotal single arm trial – however this is not always optimal. Use of single arm trials in oncology or rare diseases requires appropriate comparisons to be developed to document the benefits of the new treatment. Deriving such comparisons from real world or historical trial data is not straightforward and requires data source and methods expertise.

As the use of master protocols becomes more prevalent in drug development, Bayesian methods are extensively used to ensure optimal use of data and flexible trial designs.

Master protocols are used for umbrella trials, basket trials and other clinical trial designs that enable multiple therapies to be tested at once. They provide the rules for adding and dropping arms on clinical trials where standards of care might constantly be changing, thus requiring special tools for updating comparator arms, adding new therapies and so forth.

Methods involving Group Sequential Designs is one of the earliest deviations from a traditional two-arm clinical trial with no interim looks at the data. They add incredible value to trials through their abilities to safeguard patients, reach positive conclusions early and keep trial designs simple and streamlined.

Sequential trials also help reduce costs and the number of patients involved, but finding a positive conclusion earlier is quite important too. In the drug development process, where patent lifetime is limited, reaching a decision six months or a year earlier is a big advantage. Sample Size Re-estimation is another key tool in the modern trial designer’s toolkit that proves to be useful. Continue reading this blog to learn how to use these methods and understand how they can improve trial design.

Today, there is a need for advanced quantitative techniques to combine all available information for better decision making in health care. Bayesian statistics allow us to make probabilistic inferences on the parameter of interest, which is missing in a traditional frequentist approach. Apart from the philosophical issues, Bayesian analysis provides a practical and intuitive tool for interpretation of study results and risk evaluation of clinical hypotheses.

Cytel and Novartis are together hosting a complimentary Bayesian Virtual Symposium and an Interactive 7-part workshop. This series will expose you to cutting edge topics from industry renowned leaders in Bayesian statistics. Click the button to learn more and register.

Cytel’s Biostatistics and Statistical Programming team provides integrated solutions, by blending the expertise of programming and experience of statistics. Being a notable Functional Services Provider (FSP) in the industry, we take pride in supporting our clients as they navigate the intricacies of 21st century drug development. As our FSP division continues to grow, we are looking to hire programmers and biostatisticians. Cytel's recruitment and FSP teams are hosting a one hour long Virtual Careers Open Day on Thursday, September 10th at 11:00AM EDT. Join us to learn more about our expanding FSP team, open career opportunities and what it means to be part of Cytel. Click on the button to register for the virtual event.

A recent Cytel panel led by Vice President of Strategic Consulting Natalia Muhlemann evaluated the role that Bayesian methods played in development of a COVID-19 vaccine. The wide-ranging discussion covered the structure and utility of platform trials and the role of master protocols in infectious disease vaccines development, but also addressed the importance of adaptive Bayesian methods in the search for COVID-19 therapies.

Cytel is conducting a webinar series that introduces biostatisticians to some of the more commonly used complex innovative trial designs. Our second webinar from this series was held on June 3, 2020, with Professor Christopher Jennison. Professor Jennison spoke about the modern uses of Group Sequential Designs and Sample Size Re-estimation. Group Sequential Designs were one of the earliest deviations from a traditional two-arm clinical trial with no interim looks at the data. They still add amazing value to trials through their abilities to safeguard patients, reach positive conclusions early and keep trial designs simple and streamlined. Sample Size Re-estimation is another key tool in the modern trial designer’s toolkit.

Cytel also did an interview with Professor Jennison where he spoke to us about these methods, their origin and how they add value to the industry. Continue reading this blog for a summary of the webinar. Click on the button below to access the webinar replay and download the presentation slides.

In this blog, we speak with Christopher Jennison, Professor of Statistics at the University of Bath, UK. Professor Jennison provides us insights on group sequential methods, the origin of their implementation and the value they have been adding over the years.

Cytel is hosting a new webinar series that introduces clinical fellows, early career biostatisticians, and others interested in clinical research, to some of the more commonly used complex innovative trial designs. In our previous blog, we spoke with Zoran Antonijevic about adaptive design methods.

Join us for a complimentary webinar on June 3, 2020 where Professor Jennison is going to introduce us to the basics of group sequential designs and sample size re-estimation. Learn how to use these methods and understand how they can improve trial design.

The Cytel Trial Tracker now features summary plots that display trials by country, trial status and study design. This enables us to take a deeper dive into patterns of trial design in COVID-19 studies. This blog post explores the use of single-arm studies, numbers of multiarm studies, and more.