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

Health Technology Assessment – Joint BBS/EFSPI Seminar Flyer PDF
Health Technology Assessment – Joint BBS/EFSPI Seminar Program PDF

This joint BBS/EFSPI seminar takes place on Tuesday 23 June 2015 9:30-17:30.
Location: Actelion Pharmaceuticals, Hegenheimermattweg 95, 4123 Allschwil, Switzerland PDF

Agenda BBS Seminar Bayesian Methods in Adaptive Dose-Finding Trials PDF

This BBS seminar takes place on Monday 13 April 2015 15:30-17:00.
Location: Auditorium of the Roche Learning Center, Aeschenvorstadt 56, 4051 Basel, Switzerland

Daniel Sabanés Bové, Bayesian Learning in Oncology: A Case Study
Ying Yuan, Bayesian Data Augmentation Continual Reassessment Method (DA-CRM) for Phase I Trials with Delayed Toxicities
Daniel Lorand, Bayesian modelling for combination dose-escalation trial that incorporates pharmacokinetic data

Agenda Joint BBS-EFSPI Seminar Data Sharing in Clinical Development PDF

This joint BBS-EFSPI seminar takes place on Thursday 13 November 2014 9:15-15:30.
Location: Actelion Pharmaceuticals, Hegenheimermattweg 95, 4123 Allschwil, Switzerland PDF

Sabine Atzor, Clinical Trial Data Transparency – Environment & Expectations
Stefan Driessen, EFSPI position on EMA policy on publication of clinical data
Franz König, Big thunder, little rain?
Rebecca Sudlow, Overview of Data Sharing Initiatives in Industry and Current Experiences
Janice Branson, Practicalities of accessing and using data – Advice for Researchers
Sally Hollis, Considerations for analysis plans for data sharing requests
Katherine Tucker, Principles to maintain patient confidentiality
Guilliaume Breton, Patient Confidentiality Implementation

Agenda BBS Seminar Meta-Analysis of Clinical Safety Data PDF

This BBS seminar takes place on Thursday 2 October 2014 8:30-13:00.
Location: Bildungszentrum 21, Missionsstrasse 21, 4003 Basel, Switzerland

Stephen Evans, Do meta-analyses of adverse events have adverse effects?
Brenda Crowe, Comparison of Bayesian and Frequentist Meta-Analytical Approaches for Analyzing Time to Event Data
Michael Gaffney, Model Selection in Meta‐Analysis of Clinical Safety Data – Fixed or Random Study Effect
Amy Xia, Bayesian Meta-Analysis in Drug Safety Evaluation
Jim Slattery, Meta-analysis in EU regulation
Tarek A. Hammad, Sources of Bias in Meta-analysis of RCTs
Mark Levenson, Meta‐Analysis for Safety: Context and Examples at US FDA

Workshop of the joint working group “Adaptive Designs and Multiple Testing Procedures” of the German Region (DR) and the Basel Biometric Section (BBS) of the Austro-Swiss (ROeS) Region of the International Biometric Society (IBS) PDF

Novartis Learning Center Horburg, Müllheimerstrasse 195, 4057 Basel, Switzerland (Map of the workshop venue PDF).

Agenda BBS Seminar Applications for statisticians working with “Real-World Data” PDF

This BBS seminar is scheduled for Wednesday 7 May 2014 16:00-17:30.
Location: Biozentrum, University of Basel, Hörsaal 106, Klingelbergstrasse 50/70, 4056 Basel, Switzerland

Pamela Landsman-Blumberg, Applications for statisticians working with “Real-World Data”