Cytel Blog

An extraordinary amount of global research is underway as the COVID-19 pandemic continues to evolve and spread throughout the world. There are over 800 registered global clinical trials taking place to develop life-saving treatments and vaccines for patients. The World Health Organization is also facilitating collaboration and accelerated efforts on an unprecedented scale. In these difficult times, sponsors must utilize innovative tools and approaches to design their clinical trials in order to provide promising results for all patient populations as quickly and efficiently as possible. 

A successful virtual panel discussion was conducted by Cytel on the ongoing COVID-19 Trials, on April 15. For the second complimentary virtual panel discussion held on April 23, Cytel partnered with Certara, to present, “COVID-19: Trials, Designs and Tools for Promising Results”. It began with challenges faced by clinicians and drug developers, followed by examples of tools and trial designs currently being used to help sponsors of COVID-19 trials. Continue reading for a summary of the panel discussion.

Get free access to COVID-19 Panel slides and recording.

Cytel's team of oncology trial design and advanced analytics experts are hosting a series of complimentary webinars covering a range of innovative topics and solutions. On April 28, 2020, Cytel conducted a webinar with Professor Martin Fey, Medical Oncologist, “A Clinician’s Perspective on Cancer Drugs Development”. Our previous blog features an interview with Professor Fey where he talks about his experience of over forty years in medical oncology, the evolution of clinical cancer trials, the difference between clinically meaningful and statistically significant results, the debate around patient perspectives and other important topics around cancer drugs development.

In his webinar, Professor Fey provides us an overview of drug development for cancer treatments, clinician’s perspective on endpoints, importance of patient reported outcomes and patient perspective, and the significance of biomarkers. Continue reading this post for key highlights from the webinar.

Access webinar slides and recording by clicking on the button below.

Cytel is hosting a webinar, “A Clinician’s Perspective on Cancer Drugs Development”, on April 28, 2020. Our speaker, Professor Martin Fey, Medical Oncologist from Switzerland, will brief us on treatment evolution and give us a deep dive into clinician perspective on endpoints, PRO and patients perspectives, and importance of biomarkers in oncology.

In this interview, we speak to Professor Fey about his experience of over forty years in medical oncology, the evolution of clinical cancer trials, the difference between clinically meaningful and statistically significant results, the debate around patient perspectives and other important topics around cancer drugs development.

In this blog we turn to some reading matter, and interview Gautier Paux and Alex Dmitrienko about the recent book 'Clinical Trial Optimization with R'.  The book explores a unified and broadly applicable framework for optimizing decision making and strategy selection in clinical development, through a series of examples and case studies. To learn more, read on for Paux and Dmitrienko's insights.

 In this blog we are excited to unveil a new project which we have been hard at work on over the last few months. 

2017 marks a very special milestone for Cytel – our 30th anniversary.  Cyrus Mehta and Nitin Patel founded Cytel in 1987 with an initial objective to solve a specific problem in computational statistics.

Single ascending dose (SAD) and multiple ascending dose (MAD) studies are typically the first in human studies.  They seek to gain information on safety and tolerability, general pharmacokinetic (PK) and pharmacodynamic ( PD)  characteristics, and of course identify the maximum tolerated dose (MTD).

Conventionally, SAD  and MAD studies were conducted separately, but increasingly are combined into an ‘umbrella’ protocol which addresses both SAD and MAD objectives.

As a group, Cytel had over 40 successful regulatory interactions last year, many of which supported approvals for innovative trial design approaches.  In this blog we look at some of the key success factors for regulatory interactions regarding adaptive designs.

 Francois Beckers, Global Head of Biostatistics & Epidemiology at Merck KGaA joined us at the East User Group Meeting in March and presented case studies of Merck KGaA’s experiences with Blinded Sample Size Re-estimation in early phase studies, more specifically in the context of biosimilar studies.

On March 16th and 17th the 5th East User Group Meeting took place in London.  This very successful 2 days saw a variety of talks on aspects of clinical trial design innovation.  Over the next couple of weeks, we will be reviewing some of the key topics which were addressed during the meeting.

In this post, we'll take a look at Paul Frewer of Astrazeneca's presentation on Decision Making in Early Phase Clinical Development.  This talk was very well received by the delegates and prompted plenty of discussion afterwards.