Tutorial on statistical considerations on subgroup analysis in confirmatory clinical trials

Statistics in Medicine

Volumn 36, Issue 8, 2017, Pages 1334-1360

  Alosh, Mohamed ^a   Huque, Mohammad F ^a   Bretz, Frank ^b,c   D'Agostino, Ralph B ^d  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^b NOVARTIS PHARMA AG   (Switzerland)

^c MEDICAL UNIVERSITY OF VIENNA   (Austria)

^d Boston University   (United States)

Author keywords

negative subgroup treatment effect; supportive subgroup findings; targeted subgroup; treatment by subgroup interaction

Indexed keywords

CLINICAL TRIAL; HUMAN; STATISTICAL MODEL; ANALOGS AND DERIVATIVES; CEREBROVASCULAR ACCIDENT; HEART INFARCTION; MORTALITY; PROCEDURES; RANDOMIZED CONTROLLED TRIAL (TOPIC); REPRODUCIBILITY; SEPSIS; STATISTICAL ANALYSIS; STATISTICS; SURVIVAL ANALYSIS; TREATMENT OUTCOME;

ACETYLSALICYLIC ACID; CLOPIDOGREL; DROTRECOGIN; PROTEIN C; RECOMBINANT PROTEIN; TICLOPIDINE;

ASPIRIN; DATA INTERPRETATION, STATISTICAL; HUMANS; MODELS, STATISTICAL; MYOCARDIAL INFARCTION; PROTEIN C; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RECOMBINANT PROTEINS; REPRODUCIBILITY OF RESULTS; SEPSIS; STATISTICS AS TOPIC; STROKE; SURVIVAL ANALYSIS; TICLOPIDINE; TREATMENT OUTCOME;

EID: 85005929980     PISSN: 02776715     EISSN: 10970258     Source Type: Journal    
DOI: 10.1002/sim.7167     Document Type: Article

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