Expert workshop on subgroup analysis

• Dátum:
  péntek, 18 november 2011, Egész nap
• Helyszín:
  European Medicines Agency, Amsterdam, the Netherlands

The objective of the workshop is to present the scope and content of the proposed guidance document on subgroup analysis to internal and external experts to receive feedback for further reflection. It is focusing on the role and methodology of confirmatory and exploratory subgroup analysis in the assessment of clinical trials.

Documents

Agenda - Programme - Expert workshop on subgroup analysis

Draft Reference Number: EMA/795686/2011

Workshop report - Expert workshop on subgroup analysis

Reference Number: EMA/916257/2011

Presentation - Subgroup analyses – scene setting from the EU regulators perspective (Hemmings)

Presentation - Subgroup analysis: A view from an industry statistician (Keene)

Presentation - Reliably basing conclusions on subgroups of clinical trials (Koch)

Presentation - A Subgroup or a Subpopulation (Wang)

Presentation - Confirmatory subgroup analyses: Case studies (Bretz)

Presentation - Efficacy Claims and Subset Analyses in Phase III (Carroll)

Presentation - Adaptive clinical trials with subgroup selection (Stallard)

Presentation - Multiple testing methodology in the context of subgroup analysis (Dmitrienko)

Presentation - Use of Subgroups to “Rescue” a Trial or Improve Benefit-Risk (King)

Presentation - Subgroup analyses: from nasty business to stratified medicine – an HTA perspective (Lange)

Presentation - Panitumumab: The KRAS Story (Fletcher)

Presentation - Perspectives on analysing subgroup effects of clinical trials and their meta”analyses (Roes)