European Medicines Agency/European Federation of Pharmaceutical Industries and Associations first workshop on adaptive designs in confirmatory clinical trials

• Date:
  lördag, 15 december 2007, Hela dagen
• Plats:
  European Medicines Agency, Amsterdam, the Netherlands

Documents

Agenda - European Medicines Agency-European Federation of Pharmaceutical Industries and Associations workshop on adaptive designs in confirmatory clinical trials

Report on the European Medicines Agency-European Federation of Pharmaceutical Industries and Associations workshop on adaptive designs in confirmatory clinical trials

Reference Number: EMEA/106659/2008

Presentation - Considerations behind the reflection paper on confirmatory trials with and adaptive design

Presentation - Industry views on opportunities for adaptive designs to enhance clinical development

Presentation - Overview of regulator's experience: Adaptive designs seen in scientific advice and by the Committee for Medicinal Products for Human Use

Presentation - Some current United States Food and Drug Administration thinking on adaptive design clinical trials

Presentation - Regulatory scene setting: Benefits and risks of seamless phase I / II trials

Presentation - When is it appropriate to combine phases

Presentation - An ongoing adaptive phase II/III trial with dose selection: A pragmatic solution for a development programme

Presentation - Phase II/III adaptive design with treatment selection: A case study

Presentation - Data monitoring committee member experience: Studies with an adaptive design/confidentiality

Presentation - Monitoring processes and data monitoring committee composition

Presentation - Sponsor involvement: Current regulatory recommendations

Presentation - Considerations on guideline requirements in relation to homogeneity

Presentation - Exploring changes in treatment effects across design stages in adaptive trials

Presentation - Heterogeneity over time in clinical trials

Presentation - Heterogeneity: How much is too much?

Presentation - Harmonisation: Vision for the future

Presentation - Summary of key positions from the discussions: Regulatory (dis)agreement