PSI Webinar: Adaptive design: updated draft FDA guidance and its implications
14.00-15.30 UK Time
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.
|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.