SFO-Epi seminar: Professor Sebastian Schneeweiss
We welcome you to attend the SFO-epi seminar "Real world data analyses for regulatory decision making - a global opportunity"
Speaker: Sebastian Schneeweiss, MD, ScD, Professor of Medicine and Epidemiology, Harvard Medical School
Read more about the speaker: http://www.drugepi.org/faculty-staff-trainees/faculty/sebastian-schneeweiss/
Randomized trials are generally regarded as a valid source to establish the efficacy of medications. Concerns about their generalizability, feasibility, costs, and duration have caused regulators and health plans to look to other sources of information to augment or replace trials. This discussion is focused on the analysis of longitudinal healthcare databases or real-world data (RWD). We discuss and provide examples of the various opportunities for RWD analyses to inform on the causal relationship between drugs and outcomes. Key questions when considering whether RWD analyses can augment RCTs for regulatory decision making are when we can study drug effects without randomization and how we should implement such RWD analyses if one has decided to pursue non-randomized database studies. The when is primarily driven by externalities not controlled by investigators, whereas the how is focused on avoiding known mistakes in RWD analyses.
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If you have any questions, please contact the hosts Johan Reutfors (email@example.com) and Shahram Bahmanyar (firstname.lastname@example.org) at the Centre for Phamacoepidemiology, Clinical Epidemiology Division, Karolinska InstitutetContact person: Johan Reutfors