In September 2018 the FDA published a guidance on adaptive design for clinical trials of drugs and biologics, updating (not finalizing) its initial draft from February 2010. The main focus of the webinar will be to provide an overview of its main contents, which will be presented by Jürgen Hummel (PPD). In addition, Kaspar Rufibach (Roche) will introduce an open-source statistical software for adaptive designs, RPACT (an R package that enables the design and analysis of confirmatory adaptive clinical trials). Kit Roes will also comment on the guidance from a European Regulatory perspective, which will be followed by a brief panel discussion.
This Webinar is free to attend, to register please click here.
Jürgen Hummel joined PPD near Glasgow (Scotland) in 2006, where he is Senior Director, Statistical Science. He heads up the statistical science track within PPD Biostatistics and provides statistical consultancy both internally and externally. Specifically, he has been leading PPD’s cross-departmental Adaptive Design Working Group since it was set up 8 year ago. In his career he held a variety of technical and managerial positions within the biostatistics department of different organizations, predominantly within the CRO industry. Jürgen earned a Diplom (German equivalent of a master’s degree) in mathematics and economics at Augsburg University, Germany, and has been a chartered statistician with the Royal Statistical Society since 2006.
Kaspar Rufibach is a member of Roche's Methods, Collaboration, and Outreach group and located in Basel. He does methodological research, provides consulting to Roche statisticians and broader project teams, gives biostatistics trainings for statisticians and non-statisticians in- and externally, mentors students, and interacts with external partners in industry and the academic community in various working groups. He has co-founded and co-leads the Oncology estimand Working group that currently has 31 members from 19 companies and works on various topics around estimands in oncology. Research interests are methods to optimize study designs, advanced survival analysis, probability of success, estimands, estimation of treatment effects in subgroups, and general nonparametric statistics. Before joining Roche, Kaspar received training and worked as a statistician at the Universities of Bern, Stanford, and Zurich.
Kit Roes is Professor of Clinical Trial Methodology at the Julius Center of the University Medical Center Utrecht. His research focus is on design and analysis of clinical trials, with an emphasis of innovative designs, rare diseases and bridging the gap between clinical trials and real world evidence. He participates in the Regulatory Science Network Netherlands, is chair of Methodology at the Dutch Medicine Evaluation Board and member of the Biostatistics Working Party of the EMA. He serves on multiple Data and Safety Monitoring Boards. His experience includes over 20 years in clinical research and development in the pharmaceutical industry and academic life sciences, serving clinical research and drug development as expert as well as in different (international) senior management positions.
PSI Webinar: Wearable Technologies - Challenges and Opportunities
Wearable technologies and digital health data offer great opportunities for studying patients functionally in real life settings. Actigraphy, for example, can be used as part of clinical trials to collect continuous movement data, but the frequency of data collection results in dense datasets requiring extensive processing and signal detection. In this webinar, a panel of expert speakers will discuss how such aspects can be addressed to help realize the promise of these technologies.
Our annual PSI Medical Statistics Careers Event, will be held online using the Career Fair Plus app on Wednesday 3rd March 2021. The event will include a live online panel discussion and a virtual exhibition session.
Discover your extraordinary potential by working as a Covance AD, Biostatistics / Senior Principal Biostatistician. You will consult in the design of complex and innovative studies & clinical trial programs as well as Leading DMC/DSMB processes.
By joining our company, in this role you will apply your skills and experience in support of developing scientifically based arguments aiming to provide fair accessibility to our company’s drugs and vaccines making a real difference in patient’s lives.
Senior Principal / Principal Biostatistician (Oncology) – FSP
Join our team as a Covance FSP Senior Principal or Principal Biostatistician. You will be assigned to one Sponsor working on Phase I and II oncology studies. Previous Lead experience essential. Office or home-based anywhere in Europe or South Africa.