PSI Webinar: Master protocols - theory, application and regulatory considerations
For this webinar, PSI brings together experts on master protocols from the pharmaceutical industry, academia, and regulatory agencies.
Our next journal club features two papers on the topic of Longitudinal Data, will be held on the 16th September 2020 from 4-5pm BST.
Please click here to view the flyer.
REGISTER HERE: https://attendee.gotowebinar.com/register/2180330867722920973
Please join us to hear Florian Lasch (Hannover Medical School, Germany) and Mutamba Kayembe (Maastricht University, Netherlands) present their recent work.
The webinar will be chaired by Michael O’Kelly (IQVIA).
Florian Lasch (Hannover Medical School, Germany):- Empirical evaluation of the implementation of the EMA guideline on missing data in confirmatory clinical trials: Specification of mixed models for longitudinal data in study protocols
Authors: Sebastian Häckl, Armin Koch & Florian Lasch
Pharmaceutical Statistics, 2019; volume 18, Issue 6, Pages 636-644.
200916_empirical evaluation of EMA guideline on missing values - MMRM specifications_final
Mutamba Kayembe (Maastricht University, Netherlands):- Imputation of missing covariate in randomized controlled trials with a continuous outcome: Scoping review and new results
Author: Mutamba T. Kayembe, Shahab Jolani, Frans E. S. Tan & Gerard J. P. van Breukelen
Pharmaceutical Statistics. Early view.
Access the slides here.
For each of these published papers there will be a 20 minute presentation by author followed by a 10 minute discussion.
Papers will be made available to view prior to the meeting and presentation slides will be available a week before the JC. Journal subscribers can access papers at any time. Audio recordings will be available shortly after the JC to download from the PSI website.
The meetings are open to both PSI and non-PSI members.