OBJECTIVE
In an effort to introduce NISS to statisticians involved in the research and development of pharmaceutical products, NISS and Merck are jointly hosting a series of free virtual meetups, quarterly over the web, on emerging issues of interest to this community. The meeting will focus on the FDA draft guidance on "Multiple Endpoints in Clinical Trials" published in January this year.
Watch the recorded NISS-Merck Virtual Meet-up
| Attachment | Size |
|---|---|
 Alex Dmitrienko's slides.pdf | 41.64 KB |
| NISS_Merck_Base_Slides.pdf | 508.22 KB |
Agenda
11:00 – 11:05 NISS-Merck meetup with ground rules (Dan Holder, Merck)
11:05 – 11:10 What is NISS (Ray Bain, Merck)
11:10 – 11:25 Salient points in the FDA draft guidance (Alex Dmitrienko, Madiana Inc.)
11:25 – 11:35 Implementation of multiple comparison procedures (Frank Bretz, Novartis)
11:35 – 12:00 Panel discussions and Q&A
Moderator: Walt Offen (AbbVie)
Panelist: Lisa LaVange (FDA/CDER)
Alex Dmitrienko (Madiana Inc.)
Frank Bretz (Novartis)
