Early Evidence Generation Planning is a key activity for a successful regulatory approval and subsequent HTA and payor assessment. And it is much more than just a planning of clinical trial. Aspects such as supportive burden of illness / treatment patterns studies, external control groups, endpoint validation studies or even patient preference studies as well as supportive indirect treatment comparisons and health-economic models require an early planning and systematic screening of needs, gaps and opportunities. In this Webinar, the speakers will address these questions and will present how an early evidence generation planning can be done and how it could be transformed into a Global / Local Integrated Evidence Generation Plan.
Topics covered by this webinar are the following:
Regulatory and HTA requirements: are there differences?
European JCA: does it make a difference?
How and when to do an early Evidence Needs and Gaps Assessment?
Evidence Generation Options and their PROs & CONs
Supportive RWE
External Control Groups
Endpoint Validation Studies
Patient Preference Studies
Literature Reviews & ITCs
A Process- and tool-driven proposal to do early Evidence Generation Planning
Speakers
