Cytel Blog

In this blog, we talk with Robert Greene, Founder and President of the HungerNDThirst Foundation, about his upcoming presentation at Cytel’s East User Group Meeting on 14th and 15th November at Merck in Darmstadt, Germany. Robert will bring a fresh perspective to the discussion of the role statisticians can play in enhancing the position of patients in clinical trials. Patient-centricity is a key topic in modern drug development, and this session aims to encourage statisticians to question the importance of a more patient-centric approach within their field.

In this blog, we talk with Simon Kirby, former Senior Director at Pfizer, about his upcoming presentation at Cytel’s East User Group Meeting on 14th and 15th November at Merck Darmstadt, in Germany. Simon will address the topic of Selection Bias for Treatments with Positive Phase 2 Results and in this blog he explains why this is a key topic of particular relevance for pharmaceutical companies in today’s climate of accelerated development. He also talks with us about his career in statistics, current research, and his book Quantitative Decisions in Drug Development.

We are delighted that Stephen Senn will be joining us at the EUGM on November 14th and 15th in Darmstadt, Germany. In this blog, we sit down for a discussion with Stephen about his career in statistics, his advice for early career statisticians, his upcoming research, and the topic of his presentation at the East User Group Meeting “70 Years Old and Still Here: the Randomized Clinical Trial and its Critics”.

In this blog, we talk with Heiko Götte, Senior Expert Biostatistician at Merck about his upcoming presentation at Cytel’s East User Group Meeting on 14th and 15th November at Merck Darmstadt, in Germany. The topic Heiko will address is Decision Making in Development Programs with Targeted Therapies and he explains to us why this is a key topic for pharmaceutical companies today as they strive to improve their decision-making, and what delegates can expect to take away from the presentation.

Cytel’s 7th East User Group Meeting (EUGM) will take place on November 14 & 15, 2018 at Merck in Darmstadt, Germany, bringing together industry experts, thought leaders and applied statisticians to discuss the future of clinical trials.

The agenda has been developed collaboratively by the EUGM Scientific Committee, and keynote speakers will include Stephen Senn, Meinhard Kieser, Thomas Burnett, Robert Greene and Simon Kirby.

In this blog, we took the opportunity to talk to one of the speakers, Thomas Burnett, Senior Research Associate in Medical and Pharmaceutical Statistics at Lancaster University, about his presentation topic “Bayesian Optimization of Enrichment Designs” and his perspectives on what EUGM delegates will be able to take away from his talk.

A recent paper The case for Bayesian methods in benefit-risk assessment: Overview and future directions (1)  co-authored by Cytel Senior Vice President Consulting  Yannis Jemiai and published in Therapeutic Innovation and Regulatory Science, tackles the critical issue of benefit risk assessment, and the part Bayesian approaches can play in resolving their challenges.

There is certainly an industry- wide need for more transparent, targeted and robust benefit risk assessments. In this blog we talk with Yannis about the article and why the Bayesian framework is particularly well suited to these efforts. 

 Robust go/no-go (GNG) decision-making is essential for effectively managing risk across a clinical portfolio. In early phase development, it is particularly important to have the correct tools in place to terminate ineffective compounds quickly, while accelerating promising ones through the process. 

We continue our case study series with this example of a Phase 3 design that uses Bayesian decision making combined with frequentist final analysis.

Clinical Development Background

Our biopharmaceutical client’s lead drug candidate is a late clinical-stage cancer immunotherapy for treatment of a rare oncology indication.  Clinical development of therapies in this indication faces inherent challenges of patient recruitment and scarcity of data.

Sponsor Challenge

The sponsor had previously conducted a randomized, double-blind, placebo-controlled Phase 2 study. Moving into a confirmatory clinical trial setting, they came to Cytel for support with a trial design to address their key questions:

Did you miss our webinar on Single and Dual Agent Dose escalation designs earlier in the year?  In this blog we have made the replay available for your review, and  also  take the opportunity to recap key reasons why you should consider a model based design for your dose escalation study.