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Danish Society for Biopharmaceutical Statistics

The Danish Society for Biopharmaceutical Statistics (DSBS) was formed in March 1992 as an independent non-profit association. The aims of DSBS are to further the exchange of information between professional statisticians working for the pharmaceutical industry in Denmark and abroad, to promote professional standards, and to constitute an expert body in biopharmaceutical statistical matters. More than 200 statisticians, representing 17 companies, are members of the society

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Coming events



DSBS Course: Introduction to the R language

27 November 2018 at Novo Nordisk A/S

As preparation for the course, please install R and RStudio on your computer using these instructions. Course materials are avaiable here.



DSBS Course: Survival Analysis in Clinical Trials 2019

Part 1: 17-18 January 2019
Part 2: 31 January - 1 February 2019
at Lundbeck A/S





Recent events



DSBS meeting on Extrapolation in paediatrics and use of external data in pivotal clinical trials

14 November 2018 at Lundbeck A/S


Speaker Presentation as pdf
Franz König Beyond RCTs - using historical data in pivotal clinical trials
F König & P Bauer Adaptive paediatric investigation plans




Joint DSBS/FMS biennial meeting

23 October 2018 at Restaurant Kastrup Strandpark


Speaker Presentation as pdf
Arvid Sjölander Introduction to the field of causal inference
Christian Bressen Pipper Testing treatment equivalence in a survival setting
Philip Hougaard Recurrent events in the presence of a terminal event
Bénédicte Delcoigne Federated analyses




DSBS Course in Estimating Sample Sizes in Clinical Trials, 12-13 April 2018

Sample Size Course 2018 Flyer






DSBS Annual Meeting 2018, April 19, at Cosmopol, Fiolstræde 44

Annual Meeting 2018 Flyer






DSBS Course: Survival Analysis in Clinical Trials 2018


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PartDownloads
Part 1: 17-18 January 2018Link to downloads for Part 1
Part 2: 31 January - 1 February 2018Link to downloads for Part 2

Survival Course 2018 Flyer






Draft ICH E9 addendum on
Estimands and Sensitivity Analysis



20 November 2017 at Lundbeck A/S

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Link to guideline: ICH E9 (R1) addendum on estimands and sensitivity analysis


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Presentations from half-day meeting on Estimands
26 Oct 2017



Speaker Presentation as pdf
Agenda Detailed program
Frank Bretz How the ICH E9 addendum around estimands may impact our clinical trials
Søren Andersen & Helle Lynggaard Implementation of estimands in Novo Nordisk
Mette Krog Josiassen Applying estimand strategies in schizophrenia


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Presentations from DSBS 25th Anniversary
31 March 2017



Speaker Presentation as pdf
Agenda Detailed program
Karsten Schmidt, Claus Bay & Merete Jørgensen Biostatistics in the regulatory environment and the formation of DSBS in the 1990’s
Ralf Bender, Institute for Quality and Efficiency in Health Care (IQWiG) Evaluation of subgroup analyses in the framework of benefit assessment
Erik Doffagne, CluePoints Using central statistical monitoring to drive quality into clinical trials
Nedjad Losic, Genmab Two Bayesian designs for first-in-human trials in cancer
Anders Malmberg, Ferring A phase II trial with response-adaptive allocation
Lasse Sluth, Lundbeck and Lars Endahl, Novo Nordisk Regulatory interaction with Asia