The Cytel blog keeps you up to speed with the latest developments in biostatistics and clinical biometrics.
The rapid pace of technology has opened up numerous avenues for advanced innovative clinical trial design, but how can we use this to propel clinical development goals like maximizing revenue, or ensuring a commercially viable product? When operational constraints are limiting, how do we achieve the best possible trial design? What should we do if a competitor is edging us out of the market?
While we know that the statistical design of clinical trials can shorten trials or set realistic enrollment goals, there is still a growing need to tie these features of trial design directly to commercial revenue. Clinical development teams would ideally know how much they are willing to spend for an incremental gain in statistical power, or the marginal financial gains in waiting a week to unblind data.
The good news is the industry is getting there. Here are 5 Questions to help you begin your journey towards the Re-imagined Clinical Trial:
A new peer-reviewed article co-authored by several Cytel scientists re-examines the way in which adaptive trials are designed and implemented within the oncology space. The wide ranging paper spans numerous topics including data considerations, statistical considerations, the commercial and scientific value of flexibility in adaptive designs, and also a “Holistic Approach” to program development, wherein development plans are not created study by study, but across phases.
Interview with Kannan Natarajan: Drug Development in Rare Diseases - Need for Innovation in Statistical Thinking
Cytel is delighted to have Kannan Natarajan speaking at the “Complex Innovative Trial Design Symposium and East User Training” on November 6 in Boston, MA. We got a chance to sit down with Kannan and talk about his career in statistics, the changing role of statisticians, his views on evolving statistical thinking, estimands and relevance of technology in the context of rare diseases.
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 2011, Cytel organized its first East User Group Meeting (EUGM) in Paris. Since then, we have held an EUGM almost every year, alternating between locations in Europe and North America. These meetings have been a great success, giving opportunities for customers and industry colleagues to meet each other as well as with key opinion leaders, whilst learning more about our East software and providing critical feedback.
This year, the EUGM was held in Cambridge MA on the 25th and 26th of October. In this blog we are delighted to share the slides from some of the speakers' presentations.
Namrata Deshpande, Senior Team Lead will be participating in a round table discussion at the Women in Statistics event in California, October 19-21.
This is the first blog in a new 'Career Perspectives' series and we talk to Namrata to find out more on her career path, achievements, current role at Cytel and her interests outside of work.
Antibiotic resistance is one of the greatest challenges facing human health today. We are excited to welcome Dr. Scott Evans of the Harvard T.H Chan School of Public Health (HSPH) to the blog to discuss how the novel statistical methods he is developing could help tackle this global crisis.