European Medicines Agency workshop on the investigation of subgroups in confirmatory clinical trials

EventCorporateMedicines

Date: Friday, 7 November 2014, All day
Location: European Medicines Agency, Amsterdam, the Netherlands

The European Medicines Agency (EMA) is hosting a one-day workshop on the investigation of subgroups in confirmatory clinical trials. The workshop will follow a 6-month public consultation on the draft EMA guideline. Objectives of the workshop are to discuss the role of subgroup analyses in the assessment of confirmatory clinical trials submitted for marketing authorisation, and to receive input on positions outlined in the guideline.

Documents

Programme - European Medicines Agency workshop on the investigation of subgroups in confirmatory clinical trials

Reference Number: EMA/257665/2013

English (EN) (198.66 KB - PDF)

First published: 07/11/2014Last updated: 07/11/2014

Invitation for expression of interest - European Medicines Agency workshop on the investigation of subgroups in confirmatory clinical trials

Reference Number: EMA/257188/2013

English (EN) (119 KB - PDF)

First published: 08/05/2014Last updated: 08/05/2014

Presentation - Subgroup analyses clinical, non-statistical perspective (Jens Heisterberg)

English (EN) (983.6 KB - PDF)

First published: 02/03/2015Last updated: 02/03/2015

Presentation - Rationale for issuing the guideline and main Points (Rob Hemmings)

English (EN) (291.78 KB - PDF)

First published: 02/03/2015Last updated: 02/03/2015

Presentation - Key comments from the public consultation and the regulatory challenge (Armin Koch)

English (EN) (658.97 KB - PDF)

First published: 02/03/2015Last updated: 02/03/2015

Presentation - The investigation of subgroups in confirmatory clinical trials - The Pharmaceutical and Medical Devices Agency (PMDA) perspective (Yuki Ando)

English (EN) (259.01 KB - PDF)

First published: 02/03/2015Last updated: 02/03/2015

Presentation - Comments from the U.S. Food and Drug Administration (FDA)Working Group on Subgroup Analyses (Estelle Russek-Cohen)

English (EN) (52.97 KB - PDF)

First published: 02/03/2015Last updated: 02/03/2015

Presentation - Subgroup analyses in confirmatory trials – European Federation of Pharmaceutical Industries and Associations (EFPIA) perspectives (Albert Radlmaier)

English (EN) (144.48 KB - PDF)

First published: 02/03/2015Last updated: 02/03/2015

Presentation - Subgroups: The quest for enlightenment (Alan Phillips)

English (EN) (601.92 KB - PDF)

First published: 02/03/2015Last updated: 02/03/2015

Presentation - Discussion about the proposed different levels of subgroup analysis (Claudia Schmoor, Frank Langer)

English (EN) (33 KB - PDF)

First published: 02/03/2015Last updated: 02/03/2015

Presentation - Subgroup analysis: trying to get more from less? (Stephen Senn et al.)

English (EN) (157.22 KB - PDF)

First published: 02/03/2015Last updated: 02/03/2015

Presentation - Selection and estimation in exploratory subgroup analyses – a proposal (Gerd Rosenkranz)

English (EN) (418.92 KB - PDF)

First published: 02/03/2015Last updated: 02/03/2015

Presentation - Exploratory subgroup analysis: Post-hoc subgroup identification in clinical trials (Alex Dmitrienko, Ilya Lipkovich)

English (EN) (82.84 KB - PDF)

First published: 02/03/2015Last updated: 02/03/2015

Presentation - On the utility of subgroup analyses in confirmatory clinical trials (Brian A. Millen)

English (EN) (123.59 KB - PDF)

First published: 02/03/2015Last updated: 02/03/2015

Presentation - Open discussion

English (EN) (72.19 KB - PDF)

First published: 02/03/2015Last updated: 02/03/2015

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