The Cytel blog keeps you up to speed with the latest developments in biostatistics and clinical biometrics.
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.
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.
TOGETHER trials, and the advantages of adaptive platform designs for investigating COVID-19 therapies
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.
The TOGETHER Trial: Cytel Designs and Implements Novel Adaptive Platform Trial for COVID-19 Therapies
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.
Significance of Bayesian Model-Based Approaches in Oncology Trials: An Interview with Dr. Satrajit Roychoudhury
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.
In a recent interview with Cytel, Zoran Antonijevic, longstanding chair and leader of the DIA Adaptive Design Scientific Working Group, spoke about adaptive design methods. He gave us insights on how these methods can help achieve new levels of clinical trial efficiency and probability of success.
Cytel is conducting a webinar series that introduces biostatisticians to some of the more commonly used complex innovative trial designs. On May 20, 2020, Zoran Antonijevic joined us as a speaker at a webinar from this series, “Innovative Drug Development at a Glance - The Concepts, The Vision, & The Factors to Consider”. In the webinar, Zoran defines complex innovative trial designs, summarizes the potential benefits of each, and highlights key factors to consider when applying these techniques. Continue reading this blog for a summary of the webinar. Click the button to get free access to the webinar slides and recording.
COVID-19 Response: New Opportunities & Implications for the Future of Drug Development in Emerging Economies – Q&A with James Orbinski on Global Health Policy
On May 7, Cytel and Certara conducted a virtual panel discussion on new opportunities and implications for the future of drug development in emerging economies. The speakers included highly acclaimed key opinion leaders and industry experts who spoke about new sources of research funding being channeled towards emerging economies and the need to understand its strategic priorities to properly assess future opportunities for growth.
Our first panelist, James Orbinski is a professor at York University's Dahdaleh Institute for Global Health Research. James is an experienced medical doctor, a humanitarian practitioner, a best-selling author and a leading scholar in global health. After extensive field experience with Médecins Sans Frontières / Doctors Without Borders (MSF), Dr. Orbinski was elected MSF’s international president from 1998 to 2001. He launched its Access to Essential Medicines Campaign in 1999, and in that same year accepted the Nobel Peace Prize awarded to MSF. Our moderator from Cytel, Principal Scientist, Edward Mills began the virtual panel discussion by asking James a series of pertinent questions on the issues around the current pandemic. Continue reading this post for the Q&A.
Get access to the virtual panel replay by clicking on the button below.
In this blog, we speak with Zoran Antonijevic, longstanding chair and leader of the DIA Adaptive Design Scientific Working Group, and former Principal Statistical Consultant at Cytel. We speak about adaptive design methods, their value to the industry, their success and ways to overcome the existing challenges including the hesitation towards its wide adoption.
This summer 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. These webinars will cover the benefits of each design, and the practical considerations for adoption.
On May 20, 2020 Zoran Antonijevic is going to present an introductory overview of all these advanced design methods, in a webinar from this series. This webinar will define complex innovative trial design, briefly introduce the concepts, summarize the potential benefits of each, and highlight key factors to consider when applying these techniques. You can register by clicking on the button below.