ABSTRACT
As a practicing statistician in the pharmaceutical industry for more than 25 years, I have had the opportunity to work on numerous multiregional clinical trials. Even more fortuitous, I have had the honor of collaborating on the topic of MRCTs with very talented statisticians from across industry, academia, and government. This has provided me with an MRCT canvas that is broad in experience and perspectives. I will try to distill the experience I have acquired from my work and collaborations and just plain interesting conversations, down to a few of my favorite lessons learned and recommendations regarding multiregional clinical trials. If I have left out your, the reader’s, favorite lesson, it is because there are so many, they could fill a book. Which is what we have done – so please don’t limit yourself to this chapter/ section – this book is filled with thoughtful recommendations.
