European Medicines Agency workshop on multiplicity issues in clinical trials

• Date:
  Friday, 16 November 2012, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

The workshop's topics include usefulness and limitations of newly developed strategies to deal with multiplicity and multiplicity arising from interim decisions. Objectives are to discuss current standards and strategies to address multiplicity in clinical trials and to identify issues where guidance is missing so far.

Documents

Agenda - Programme - European Medicines Agency workshop on multiplicity issues in clinical trials

Reference Number: EMA/519224/2012

European Medicines Agency workshop on multiplicity issues in clinical trials - Invitation for expressions of interest

Reference Number: EMA/308884/2012

Workshop on multiplicity issues in clinical trials: Report

Reference Number: EMA/743074/2012

Presentation - CHMP's view on multiplicity through assessment, advice and guidelines (Rob Hemmings)

Presentation - Multiplicity issues in Food and Drug Administration - reviewed clinical trials (Kathleen Fritsch)

Presentation - Current experience with multiplicity issues in Pharmaceuticals and Medical Devices Agency (Eisuke Hida, Yuki Ando)

Presentation - The update of the multiplicity guideline (Norbert Benda)

Presentation - Multivariate analysis of treatment in multiple sclerosis using the Wei-Lachin procedure (Thomas Zwingers)

Presentation - Multiplicity corrections in bioequivalence trials (Jiri Hofmann)

Presentation - Discussion of multiplicity corrections in bioequivalence trials (Thomas Lang)

Presentation - Case study: a phase-3 study with two doses and secondary endpoints (Vincent Haddad)

Presentation - Discussion of case study 3: a phase-3 study with two doses and secondary endpoints (Franz Konig)

Presentation - Multiplicity issues in defining the testing strategy for two large outcome studies (Jennifer Shannon, Rebekkah Brown, Greg Cicconetti, Rich Davies)

Presentation - Multiplicity and estimation (Peter Bauer)

Presentation - Gatekeeping strategies in phase III clinical trials with multiple endpoints and doses (Alex Dmitrienko, Olga Marchenko)

Presentation - Novel multiple testing procedures for structured study objectives and families of hypotheses – a case study (Guenther Mueller-Velten)

Presentation - Multiplicity: Is it of value to make it so complicated? (Andrew Stone)

Multimedia