Adaptive design in early phase clinical trials
Thank you for your interest in the recording of our recent webinar. During this webinar James Matcham, Vice President Strategic Consulting at Cytel, will discuss how small to medium Biotech's taking their early steps into clinical development often do not have the technical expertise in adaptive trial design needed to accelerate their early trial clinical trial programs. This webinar will outline the trends in the use of adaptive design in early phase clinical trials.
- The use of Bayesian (and other) dose escalation designs
- Early proof of concept designs
- Designs with Combination products
- Adaptive Dose finding designs
- Population Enrichment designs
James Matcham joined Cytel in April 2020 as a Senior Principal in the Strategic Consulting team. He began his career with 5 years working as a Research Fellow at the Applied Statistics Research Unit at the University of Kent. He then completed 21 years at Amgen where he worked on the development and regulatory/reimbursement approval of many of their biotechnology products, representing the company at regulatory submissions in the US and the EU and eventually chairing the company’s International Protocol Review Committee. His last few years there were spent working to improve literature review, the use of adaptive and early phase design, network meta-analysis, Bayesian methods and quantitative decision making. More recently he spent 6 years at AstraZeneca as Head of Early Clinical Development Biometrics, responsible for clinical development plans, decision making and the design and analysis of phase 1, 2a and 2b trials. During this time he pioneered the use of quantitative decision making and the use of innovative clinical trial design and advanced analytics.
James has been a member of UK society for Pharmaceutical Statisticians (PSI) for over 30 years, serving on the Scientific and Training Committees as well as the Board of Directors. He has also served on the Professional Affairs Committee of the Royal Statistical Society and contributed to other industry-wide activities. He has been a Chartered Statistician of the Royal Statistical Society for over 25 years and has over 30 publications in refereed scientific journals and two contributed book chapters.