[Statlist] FW: Joint EFSPI/BBS Virtual Seminar - FINAL Announcement: “The application of estimands from a Neuroscience perspective” (Nov 3, 2020)

[Blatna, Bibiana]

Dear Colleagues,

please find attached the final announcement of the EFSPI-BBS seminar on  the application of estimands from a Neuroscience perspective. It would be great if many of you would find the time to join, not only when you work on Neuroscience projects but also beyond as the topics discussed are certainly also important for other areas.

See you then and stay safe!

Uli Burger
BBS president




Final Announcement:

“The application of estimands from a Neuroscience perspective”

November 3, 2020

Virtual seminar

13.00 am - 16.30 pm CET



This seminar covers the use of estimands in Neuroscience. Neuroscience is a heterogeneous therapeutic area in which development pathways and study analyses can substantially differ between different indications. Efficacy is usually based on longitudinal assessments which makes the application of the estimand framework specifically interesting and rich with many specific aspects from which we all can learn a lot.



A European scientific interest group (SIG) sponsored by EFSPI and PSI is working out in some typical Neuroscience indications how to best apply the estimand framework. This work is in progress and the seminar will provide an overview on the status of the working group including an opportunity to discuss issues and provide feedback. Finally, since the SIG also worked on the impact of Covid-19 pandemic in Neuroscience this topic will also be covered in the seminar.  The seminar is not an introduction into the estimand framework. For more information see https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e9-r1-addendum-estimands-sensitivity-analysis-clinical-trials-guideline-statistical-principles_en.pdf .



Organizing committee:

Hans Ulrich Burger, Khadija Rantell, Nikolaos Sfikas, Peter Quarg on behalf of the European working group on Estimands in Neuroscience.



Final Agenda





13:00-13:10               Welcome

                                    Introduction to the estimand framework

                                    Hans Ulrich Burger, BBS president



13:10-13:30               Outline of an estimand strategy in MS

                                    Nikolaos Sfikas, Novartis



13:30-13:50               Outline of an estimand proposal in migraine prevention and neuropathic pain

                                    Mette Krog Josiassen, Lundbeck and Peter Quarg, Novartis



13:50-14:10               Using the Estimand Framework to address challenges in AD

clinical trial with a closer look at the hypothetical strategy

                                    Paul Delmar, Hoffmann-La Roche AG



14:10-14:30               Estimands in Huntington’s disease

                                    Carrie Li, Hoffmann-La Roche AG



14:30-14:45               Break



14:45-15:05               Impact of Covid-19 on studies in Neuroscience
Andrew Hartley, PPDI



15:05-15:45               Regulatory aspects of the estimand framework: Clinical and statistical perspectives
Joel Raffel, MHRA and Khadija Rantell, MHRA



15:45-16:30               Panel discussion including all speakers and Anja Schiel, Norwegian agency and CHMP member



16:30                          End of the meeting



Venue



Virtual seminar.

The event is for free.





Registration



Please register via the following link
BBS Seminar - “Estimands in Neuroscience”<https://docs.google.com/forms/d/e/1FAIpQLSeNQUG5LkYOx_9b9gffuxL_NqayORwsT53liY_feej6LOtWaQ/viewform?vc=0&c=0&w=1&flr=0&usp=mail_form_link>





Questions for
Q&A



Please send questions for the panel discussion to

Hans Ulrich Burger

hans_ulrich.burger at roche.com<mailto:hans_ulrich.burger at roche.com>

or use the chat room during the meeting.


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