PSI ToxSIG Webinar: Combining Sexes
The webinar will provide a general introduction to the topic of combining sexes for statistical analysis in Toxicology. It will also discuss guideline recommendations pertaining to this topic.
This SIG will have two connected topics:
The group did work on the impact of Covid-19 pandemic on clinical trials in Neuroscience and provides recommendations. This is thought to be a living document with regular updates.
November 3, 2020
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 .
Below are the presentations of the workshop and a Here is the link to the recording.
The working group on AD under ASA includes a substream on estimands in AD and possible replacements for MMRM. This work will however, unlikely cover all work needed for Neuroscience in general, as there are specific differences in AD versus overall Neuroscience.
Certain areas of high unmet medical need and restricted development options like rare diseases in Neuroscience would not be addressed by the AD working group.
|Christopher Coffey||University of Iowa|
|William S Clark||Lilly|
|David S Keller||Pfizer|
|Fabian Model||Hoffmann-La Roche|
|Klaus Groes Larsen||Lundbeck|
|Markus Abt||Hoffmann-La Roche|
|Mette Krog Josiassen||Lundbeck|
|Weining (Winnie) Robieson||Abbvie|
|Hans Ulrich Burger||Hoffmann-La Roche|