Program BBS Spring Seminar The use of external data for decision making PDF

This BBS seminar takes place on Friday 5 May 2017 9:00-17:00.
Please register by sending an email in advance to
Registration will close on Thursday 27 April 2017
Location: Actelion Auditorium How to get to Actelion Allschwil

David Evans, Reality and Real-World Data
Ralf Bender, Use of registries and observational data in the benefit assessment of medical interventions
Frank Bretz, Threshold-crossing: A Useful Way to Establish the Counterfactual in Clinical Trials?
David Dejardin, Dynamic borrowing of historical data: Performance and comparison of existing methods based on a case study
Eva-Maria Didden, GetReal: 3 Years on!
Tim Friede, The Use of External Data for Decision Making

Agenda BBS Seminar Biomarker analyses PDF

This BBS seminar takes place on Monday 13 March 2017 15:00-16:30.
Location: Roche ITC Learning Center, Aeschenvorstadt 56, Basel

Agenda BBS Seminar Safety monitoring during the life cycle of a drug PDF

This BBS seminar takes place on Tuesday 29 November 2016 15:00-17:00.
Location: Actelion Pharmaceuticals, Hegenheimermattweg 95, Robert Cawthorn Auditorium (Building H95), 4123 Allschwil, Switzerland

Conny Berlin, Safety monitoring during the life cycle of a drug
Yusuf Tanrikulu, Signal Detection – Quantitative Analysis of Safety Data
Pritibha Singh, Adverse Drug Reaction (ADR)
screening in clinical trials

Gianmario Candore, Screening for adverse reactions in EudraVigilance
Soheila Aghlmandi, Choice of priors in rare events

Agenda BBS Seminar Synthesis of Evidence: Observational studies and Meta-analysis PDF

This BBS seminar takes place on Monday 14 November 2016 15:00-17:45.
Location: Roche Learning Center, IT Training Center, Aeschenvorstadt 56, Basel

Agenda Ad-hoc BBS Seminar Missing Data and Graphical Models PDF

This BBS seminar takes place on Monday 17 October 2016 15:00-17:00.
Location: Roche Learning Center, IT Training Center, Aeschenvorstadt 56, Basel

Agenda PSI/BBS one day meeting Time-to-Event and Recurrent Event Endpoints PDF

This PSI/BBS one day meeting takes place on Wednesday 14 September 2016 8:30-16:00.
Location: Novartis Pharma AG, Novartis Campus, CH-4056 Basel, Switzerland
For more information see also

Agenda BBS Seminar Adaptive Designs PDF

This BBS seminar takes place on Wednesday 4 May 2016 9:00-11:30.
Location: Novartis Campus, Auditorium of building WSJ-210 (1st floor)

Franz König, Regulatory and methodological issues in adaptive designs for confirmatory trials
Peter Bauer, DMC membership experience
David Lawrence, Using a DMC for dose selection in a phase IIb/III adaptive design: the INHANCE study
Alexander Strasak, Adaptive seamless phase II/III study in gastric cancer

Final Announcement BBS Spring Seminar PDF

This BBS seminar takes place on Thursday 28 April 2016 9:00-17:00.
Location: Roche Learning Center, Aeschenvorstadt 56, Basel

Kaspar Rufibach, Event projection: quantify uncertainty and manage expectations of broader teams
Beat Neuenschwander, Predicting milestone events for time-to-event trials
Melissa Penny, Model-based public health impact and cost-effectiveness estimates informing the WHO recommendation on malaria vaccine RTS,S (presentation not available)
Iain Bennett, Designing in Treatment Switching (case study review and recommendations) (presentation not available)
Viktoriya Stalbovskaya, Practical aspects of handling treatment switching in randomized clinical trials
Daniel Sabanes, Cancer immunotherapies: Which efficacy endpoints and statistical analyses to use?
Andrew Stone, Non-Proportional Hazards – So What?
Karine Lheritier, Complex study design in patients with Hereditary Periodic Fevers, an orphan autoimmune disease (presentation not available)
David Dejardin, Bayesian dual endpoint decision making in combination studies
Alessandro Matano, Bayesian approach for Combination Phase I Trials in Oncology (presentation not available)

Agenda BBS Seminar Disease and Product Registries PDF

This BBS seminar takes place on Wednesday 13 January 2016 8:00-13:30.
Location: Auditorium Gehry Building (Fabrikstrasse 15), Novartis Campus, Basel

Tim Friede, Clinical registries: Use and Emerging Best Practices
Eva‐Maria Didden, Learning and Predicting Real‐World Treatment Effect based on Randomized Controlled Trials and Registry Data – A Case Study in Rheumatoid Arthritis
Heiner C. Bucher, Making Better Use of Registry Data in Designing Pragmatic Trials
Yvonne Geissbühler, Use of Registries to Collect Pregnancy Data
Brian Hennessy, Registries in Rare Diseases / Orphan Drugs along with 2 Case Studiespresentation currently not available
Helene Karcher, Leveraging Real‐World Registry Data to Optimize the Design of Phase 3 Studies – a Case Study in Schizophrenia

BBS Seminar Prediction

This BBS Seminar takes place on Tuesday 27 October 2015 15:30-17:30.
Location: Roche IT Training Center, Aeschenvorstadt 56, 4052 Basel

Kaspar Rufibach (joint work with Markus Abt and Uli Burger), Bayesian Predictive Power: the bathtub problem
Evgeny Degtyarev, Designing Phase 2 to predict success in Phase 3 study