Does it help that efficacy has been proven once we start discussing (added) benefit?

Author:

Koch Armin1,Ziert Yvonne1

Affiliation:

1. Institut für Biometrie Medizinische Hochschule Hannover Carl‐Neuberg‐Straße 1 30625 Hannover Germany

Funder

FP7-HEALTH-2013-INNOVATION-1

Publisher

Wiley

Subject

Statistics, Probability and Uncertainty,General Medicine,Statistics and Probability

Reference25 articles.

1. No inconsistent trial assessments by NICE and IQWiG: different assessment goals may lead to different assessment results regarding subgroup analyses

2. A randomised, blinded, trial of clopidogrel versus aspirin in patients at risk of ischaemic events (CAPRIE)

3. Committee for Medicinal Products for Human Use. (1998). ICH Topic E9: statistical principles for clinical trials.CPMP/ICH/363/96. Retrieved July 12 2013 fromhttp://www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002928.pdf.

4. Committee for Medicinal Products for Human Use. (2010). Concept paper on the need for a guideline on the use of subgroup analyses in randomised controlled trials.EMA/CHMP/EWP/117211/2010.

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