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

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Date

sobota, 15 December 2007, All day

Lokacija

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

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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

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

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

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

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

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

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Presentation - When is it appropriate to combine phases

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

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

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

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Presentation - Monitoring processes and data monitoring committee composition

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Presentation - Sponsor involvement: Current regulatory recommendations

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Presentation - Considerations on guideline requirements in relation to homogeneity

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

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Presentation - Heterogeneity over time in clinical trials

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Presentation - Heterogeneity: How much is too much?

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Presentation - Harmonisation: Vision for the future

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

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