Regulators are promoting innovation to speed up drug development. Subsequently, there is increasing interest in the use of Real World Data (RWD) within clinical development. One application of RWD is as an external control to replace control arms in clinical studies. This webinar will review the Biostatistical challenges associated with using data collected outside of the clinical trial as an external control. Case studies where external control groups have been successfully used to support regulatory submissions will be presented. The presentation will also provide guidance on how the use of external controls can be justified.
Dr Alan Phillips has over 37 years of experience in the pharmaceutical sector gained at Wyeth and ICON. His experience combines development strategy with operational execution. He has experience of regulatory submissions in a plethora of different therapeutic areas including biosimilars, CNS, Oncology and Women’s Health. Dr. Phillips represents sponsors at US and EU scientific advisory and approval meetings, and sits on a number of Data Monitoring Committees. Alan received his B.Sc. degree in mathematics from the University of Exeter, his Ph.D. in statistics from the University of Birmingham and is a Chartered Statistician. He has published in a number of areas including estimands, adaptive trial designs, regulatory statistical challenges, sample size estimation, and statistical principals for clinical trials. Alan is affiliated with the Royal Statistical Society (RSS) and Statisticians in the Pharmaceutical Industry (PSI). In 2012, Dr Phillips was made an Honorary member of PSI. Alan is also an Adjunct Associate Professor at University College Dublin and visiting Senior Lecturer at King’s College.
