This webinar will focus on the role of Medical Affairs to lead patient engagement in clinical development.
In this webinar we will explore practical approaches to engaging patients in early development, introducing key resources and discussing best practices. These discussions will be tailored to meet the needs of all Medical Affairs colleagues, regardless of experience.
Part 2 of this series will discuss statistical analysis in clinical trials including null/alternative hypotheses; statistical assumptions (type I error, significance level, type II error, statistical power); hypothesis testing; Statistics used in RCTs, including type of outcome measures, analysis of time-to-event variables (plotting and interpretation of Kaplan-Meier curves).
Early Access includes a variety of programs by which pharmaceutical companies make investigational therapies available to patients with life-threatening diseases. These patients have either exhausted available treatments or have no approved options. This presentation will review the processes and procedures to consider in the implementation of an Early Access Program and explore the opportunities and challenges posed therein.