Multiplicity in confirmatory clinical trials: a case study with discussion from a JSM panel

An invited panel session was conducted in the 2012 Joint Statistical Meetings, San Diego, California, USA, to stimulate the discussion on multiplicity issues in confirmatory clinical trials for drug development. A total of 11 expert panel members were invited and 9 participated. Prior to the session...

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Veröffentlicht in:	Statistics in medicine 2015-11, Vol.34 (26), p.3461-3480
Hauptverfasser:	Wang, Sue-Jane, Bretz, Frank, Dmitrienko, Alex, Hsu, Jason, Hung, H. M. James, Koch, Gary, Maurer, Willi, Offen, Walt, O'Neill, Robert
Format:	Artikel
Sprache:	eng
Schlagworte:	accelerated approval biomarker endpoint Clinical trials Clinical Trials, Phase III as Topic - statistics & numerical data Congresses as Topic Data Interpretation, Statistical decision theoretic Drug Discovery - statistics & numerical data Endpoint Determination - methods Humans Infant, Newborn Medical treatment multiplicity in regions primary and key secondary endpoints R&D Research & development Research Design - statistics & numerical data Respiratory Distress Syndrome, Newborn - drug therapy Treatment Outcome
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