September 24, 2019

There is a growing interest in pre-approval collection of real-world data (RWD) in early access programs, which manufacturers often set up for the provision of an investigational medicinal product to patients who are ineligible or otherwise cannot participate in the drug’s clinical trials.

Early access programs are not research studies in the conventional sense, but regulatory bodies require adverse event reporting from these programs, and it is permissible to collect treatment outcomes, patient experience data and other real-world measures.

This webinar will provide an overview of early access programs including regulatory context, types of real-world measures of interest and lessons learned from a recent case study.