[LMU-OSC News] Upcoming talk on "Design of Replication Experiments"

LMU Open Science Center News lmu-osc at lists.lrz.de
Thu Dec 12 11:45:04 CET 2019


[News from our website: 
https://www.osc.uni-muenchen.de/news/held/index.html]

##Upcoming talk "The harmonic mean chi-squared test to substantiate 
scientific findings"

by Prof. Dr. Leonhard Held, Professor of Biostatistics at the University 
of Zurich and Director of the Center for Reproducible Science

**Abstract**:

Statistical methodology plays a crucial role in drug regulation. 
Decisions by the FDA or EMA are typically made based on multiple primary 
studies testing the same medical product, where the two-trials rule is 
the standard requirement, despite a number of shortcomings. A new 
approach is proposed for this task based on the (weighted) harmonic mean 
of the squared study-specific test statistics. Appropriate scaling 
ensures that, for any number of studies, the null distribution is a 
chi-squared distribution with one degree of freedom. Further properties 
are discussed and a comparison with the two-trials rule is made, as well 
as with alternative research synthesis methods. An attractive feature of 
the new approach is that a claim of success requires each study to be 
convincing on its own to a certain degree depending on the significance 
level and the number of studies. A real example with 5 clinical trials 
investigating the effect of Carvedilol for the treatment of patients 
with moderate to severe heart failure patients is used to illustrate the 
methodology. As a by-product, the approach provides a calibration of the 
sceptical p-value recently proposed for the analysis of replication 
studies.

**Speaker**:

Leonhard Held is Professor of Biostatistics at the University of Zurich 
and Director of the Center for Reproducible Science.

**When**: 5.2.2020 von 16:00 - 18:00 Uhr
**Where**: Luisenstrasse 37, Raum C006

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