Knowledge

In today’s episode, we discuss the process with the FDA publishing a timeline of planned public workshops, draft guidance documents and final guidance documents for 4 documents, originally planned to finish in end 2021 and its objective to explore the factors that need to be considered when developing COA-based endpoints.

What is medical affairs? Launch and Lifecycle?
How has this area evolved over the last 2 decades?
What is the current state across the industry in terms of the role of statistics in this space?

This is a series of episodes and today’s content is the first episode.

When there is one topic, which is really hot, it’s causal inference. I’ve got in contact with it about 20 years ago when analysing observational studies and when nobody working on clinical trials would consider it. But now – after the introduction of the estimands framework – this becomes part of every statisticians toolkit. Today, we have one of the world leading experts in this field as a guest – Miguel Hernan.

There’s a lot of community charity work we can all do but there is not a lot of work where we can maximise our impact by using our specific skills as programmers, as statisticians, and as data scientists.

In today’s episode, we will explore what knowledge you need to gain in order to decrease your frustration in this part.