Cytel Blog

Significant advances have been made to enhance the efficiency of clinical trial designs. However, the traditional methods deployed by many pharmaceutical companies are fraught with challenges. Much less consideration is given to the value of decisions in the context of development programs or portfolios.

Cytel recently launched the “C-Suite Webinar Series”, an online initiative to help pharmaceutical executives drive commercial success with strategic insight from statistics. As a part of this series, Zoran Antonijevic, Head of Biometrics at MedSource, conducted a webinar where he describes methods for maximizing the value of programs and portfolios. This event was attended by numerous biopharma leaders.

Continue reading this blog to understand the concepts of program and portfolio optimization and learn about the benefits and opportunities presented by them.

Platform trials are a new type of clinical trials where multiple interventions can be evaluated simultaneously against a common control group within a single master protocol. Platform trial designs are an extension of adaptive trial designs that are sometimes referred to as a multi-arm, multi-stage (MAMS) design, as multiple interventions (‘‘multi-arm’’) undergoing multiple interim evaluations (‘‘multi-stage’’) are part of the design features.

This autumn Cytel has been holding a number of webinars on Platform Trials, ranging from a discussion with Cyrus Mehta on statistical innovations to incentivize more sponsors to consider platform trials, to next week's event with Jason Connor (Confluence) on the use of Bayesian methods for these innovative trial designs. 

In a recent webinar Jay Park, Director of Trials Research for Cytel in Canada, presented a webinar to review the concept of platform trials and discuss important design considerations for platform trials. Jay is the author of several leading papers on Platform Trials, including one in CA: A Cancer Journal for Clinicians, the journal with the world's highest impact factor. He has also produced a complimentary primer on the subject which you can download here.

Continue reading this blog to get a summary of his talk. Click the button to access the on demand webinar.

Even before the era of COVID-19, significant attention was channeled to the overwhelming potential of adaptive MAMS designs. Short for multi-arm multi-stage designs, these trials enable numerous therapies to be tested on a single platform with a single comparator arm. When patients are too few or there are several therapies in competition with each other to enroll, adaptive MAMS designs expedite the discovery of new drugs.

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 has recently designed and implemented the TOGETHER Trials, funded by the Bill & Melinda Gates Foundation to generate knowledge to help fight COVID-19, particularly in low and middle-income countries. The trials, with sites in Brazil and South Africa, test three existing interventions as possible treatments for COVID-19 in high-risk adults who do not require hospitalization, compared to a placebo.

The TOGETHER trials use an adaptive platform design. This type of design is particularly useful for contexts such as COVID-19 response, where there are many unknowns and a need for accelerated and resource-efficient answers, for 5 reasons.

Cytel has designed and implemented a novel adaptive platform trial for early stage COVID-19. The severity of the coronavirus emerges in five stages, with the majority of clinical trials focusing on therapies for the final stage of the disease. According to the Cytel Clinical Trial Tracker, only 6 of 2000 trials are focused on early stages; staggering given that only 5% of coronavirus cases are considered severe.

Last week, Cytel conducted its third webinar in the new introductory webinar series on Complex Innovative Trial Designs. Our speaker, Dr. Satrajit Roychoudhury is a Senior Director, Statistical Research and Data Science Center at Pfizer. In this webinar, Dr. Roychoudhury gets into the basics of phase I designs in oncology trials, explains the caveats of frequently used traditional designs and provides insights on how implementing a model-based approach can enable a better statistical inference and decision-making. You can watch the replay of the webinar and access the slides by clicking on the button.

We also had the privilege to interview Dr. Satrajit Roychoudhury. Read our blog where he talks about his interest in statistics, explains the concept of Bayesian model-based approaches and their importance in oncology trials.

Cytel conducted a webinar with Dr. Satrajit Roychoudhury, Senior Director, Statistical Research and Data Science Center, Pfizer. Dr. Roychoudhury talked about practical model-based approaches for phase I oncology trials. This webinar is a part of Cytel’s “Introduction to Complex Innovative Trial Designs” webinar series. You can watch the recording by clicking on the button below.

In this blog, we bring to you an insightful interview with Dr. Satrajit Roychoudhury where he talks to us about his interest in statistics, explains the concept of Bayesian model-based approaches and their importance in oncology trials.

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.