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

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.

Access Replay

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

Read More

Interview with Dr. Thomas Burnett on Adaptive Enrichment

July 13, 2020

Cytel is hosting a complimentary webinar series that introduces biostatisticians and other members of the development team to some of the more commonly used complex innovative trial designs, the benefits of each, and the practical considerations for adoption. You can access the replay of the completed webinars and register for the upcoming ones by clicking on the button.

Register

In this blog, we interview Dr. Thomas Burnett who is a Senior Research Associate in Medical and Pharmaceutical Statistics at Lancaster University. His main research interests are Adaptive clinical trials and personalized medicine. In the upcoming Cytel webinar on July 15, Thomas will be presenting on the foundational elements of enrichment strategies and adaptive designs.

Read More

Adaptive Population Enrichment in a Phase III Oncology Trial

January 16, 2020

 

January’s Cytel Trial Design Innovations (CTDI) Webinar Series will feature Biostatistician and pioneering Bayesian trial-designer Pantelis Vlachos. Next week, Dr. Vlachos will speak on high-efficiency trial design for Event-Based Studies, particularly in oncology and cardiovascular trials. In this blog post, we offer a glimpse of Dr. Vlachos’ last CTDI Webinar (February 2019) on high-efficiency trial design using enrichment strategies.

Don't miss next week's webinar "Designing Event-based Studies: Reduce Sample Size and Increase Predictability"! Click on the button below to register.

Register

Read More

New publication addresses critical issues in ultra-orphan indications

November 5, 2018


Cytel biostatisticians Cyrus Mehta and Lingyun Liu, together with Charles Theuer, CEO of TRACON Pharmaceuticals have recently co-authored a publication in the journal Annals of Oncology: “ An Adaptive Population Enrichment Phase 3 Trial of TRC105 and Pazopanib Versus Pazopanib Alone in Patients with Advanced Angiosarcoma (TAPPAS Trial)”. The paper explores the features of this innovative population enrichment, adaptive sample size re-estimation trial and how it overcomes some fundamental challenges of clinical development in ultra-orphan oncology indications. The publication is timely, in the context of the August 2018 news that the FDA has launched a complex and innovative designs pilot program to facilitate and advance the use of complex adaptive, Bayesian, and other novel clinical trial designs in late-stage drug development. The initiative seeks to further innovation by allowing the FDA to publicly discuss those trial designs that are being considered through the pilot program. Indeed, the TAPPAS trial incorporated regulatory input from both the FDA and EMA and received a Special Protocol Assessment from the FDA. As of the date of publication, the authors were not aware of any other pivotal population enrichment trial that has been implemented in oncology, and therefore the paper’s deconstruction of the design’s key elements will be invaluable to researchers considering similar innovative approaches.

Read More