Dose selection in seamless phase II/III clinical trials based on efficacy and safety

Statistics in Medicine

Volumn 28, Issue 6, 2009, Pages 917-936

  Kimani, Peter K ^a   Stallard, Nigel ^b   Hutton, Jane L ^a  

^a UNIVERSITY OF WARWICK   (United Kingdom)

^b UNIVERSITY OF WARWICK   (United Kingdom)

Author keywords

Closure principle; Combination tests; Conditional power; Predictive power; Seamless phase II III clinical trials

Indexed keywords

DRUG;

ARTICLE; CLINICAL RESEARCH; CONTROLLED STUDY; DECISION MAKING; DOSE RESPONSE; DRUG EFFICACY; DRUG SAFETY; MATHEMATICAL COMPUTING; POWER ANALYSIS; PROBABILITY; SIMULATION; DOSE CALCULATION; HUMAN; MEDICATION ERROR; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; STATISTICAL MODEL; STATISTICS; TREATMENT OUTCOME;

CLINICAL TRIALS, PHASE II AS TOPIC; CLINICAL TRIALS, PHASE III AS TOPIC; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG DOSAGE CALCULATIONS; HUMANS; MEDICATION ERRORS; MODELS, STATISTICAL; TREATMENT OUTCOME;

EID: 65549144401     PISSN: 02776715     EISSN: 10970258     Source Type: Journal    
DOI: 10.1002/sim.3522     Document Type: Article

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