Recent scientific advancements in human genome research have led to increasing drug discovery on personalized medicine. Single arm trials (SAT) are often used as study designs during drug development in hematology and oncology because of first in class and lack of existing comparators. However, SAT is not only facing challenges from regulatory review and approval due to methodology and evidence accepted by drug review authorities, it is also experiencing issues from health technology assessment (HTA) perspective for considerations of access and reimbursement.

Panel experts from Asia and the US will highlight opportunities and challenges of SAT in personalized medicine and share their experience and raise considerations of new methodology. The objective of this panel is to continue exploring a better framework how SAT should be considered from access perspective for the ultimate goal of improving patient care to innovative medical technology.