A meet-up is an online get together of people who have a common interest. NISS and Merck have found a large audience and many topics that have interested quite a few!
To date there have been four meet-ups averaging nearly 300 attendees calling in per event! The format is usually a short talk by 2 or more invited speakers followed by a panel discussion which includes a moderator’s perspective, their questions and questions submitted by the audience. The meet-up lasts for an hour. The talk is recorded (see screenshots) and shared on the NISS website (follow links below) for folks that could not connect to the live event.
Multiple Endpoints in Clinical Trials
The first virtual meet-up in September of 2017 jointly hosted by NISS and Merck was an effort to introduce NISS to statisticians involved in the research and development of pharmaceutical products. The focus of the meet-up was to discuss the FDA draft guideline on "Multiple Endpoints in Clinical Trials" which had been published in January 2017.
Estimands and Sensitivity Analysis in Clinical Trials
The second NISS-Merck meetup was held in January, 2018 and the topic of discussion was “Estimands and Sensitivity Analysis in Clinical Trials”. E9(R1) is an addendum to ICH E(9) which describes Statistical Principles for Clinical Trials. Both ICH E9 and E9(R1) were prepared under the auspices of the International Council for Harmonisation.
Applications of Machine Learning in the Pharmaceutical Industry
The third meet-up took place in April of 2018. Machine learning has been used to create algorithms for effective web searches, speech recognition, self-driving cars and a host other useful purposes. It is a technology that is both powerful and pervasive. This meet-up discussed how these algorithms and this mode of thinking have been applied to problems in the pharmaceutical industry.
Real World Data and its Applications in the Pharmaceutical Industry
The fourth NISS-Merck Meet-up took place in October of 2018. Complete reliance on Randomized controlled trials (RCTs) comes at a price, as they are often not only costly but limited to very specific clinical circumstances. Patients in the RCTs are not necessarily representative of the target patients in the real world setting. On the other hand, real world data (RWD) do not provide the same assurances against biases, but have the potential to provide rich, diverse, and important information on compound performance in more realistic clinical settings. Unfortunately, data collection in the real world setting may be less rigorous and difficult to verify. This meet-up focused on the roles that RWD can play in compound development, registration, and post approval.
Future Meet-ups
The next NISS-Merck meet-up is scheduled to be held sometime in January 2019 and the topic will be on “Statistical Challenges in Immuno-Oncology”. This promises to be another topic of much interest. Details will be published on the NISS website when they become available. Don’t miss it!
If you have any suggestions for future meet-up topics and/or speakers that wouldn’t mind spending a lunch hour with 300+ colleagues, please contact Dan Holder (dan_holder@merck.com) with your ideas.