Practical guidelines for adaptive seamless phase II/III clinical trials that use Bayesian methods

Statistics in Medicine

Volumn 31, Issue 19, 2012, Pages 2068-2085

  Kimani, Peter K ^a   Glimm, Ekkehard ^b   Maurer, Willi ^b   Hutton, Jane L ^c   Stallard, Nigel ^a  

^a UNIVERSITY OF WARWICK   (United Kingdom)

^b NOVARTIS PHARMA AG   (Switzerland)

^c UNIVERSITY OF WARWICK   (United Kingdom)

Author keywords

Conditional power; Power; Predictive utility; Seamless phase II III clinical trials; Separate programme

Indexed keywords

ALLOPURINOL; FEBUXOSTAT; NEW DRUG; PLACEBO; URATE;

ARTICLE; BAYES THEOREM; CALCULATION; CONDITIONAL POWER; DOSE RESPONSE; DRUG EFFICACY; DRUG SAFETY; ESTIMATED UTILITY; HUMAN; HYPERURICEMIA; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); POSTERIOR DISTRIBUTION; PREDICTIVE UTILITY; PROBABILITY; SAMPLE SIZE; STATISTICAL CONCEPTS; STATISTICAL DISTRIBUTION; URIC ACID BLOOD LEVEL;

BAYES THEOREM; BIAS (EPIDEMIOLOGY); BIOMETRY; CLINICAL TRIALS, PHASE II AS TOPIC; CLINICAL TRIALS, PHASE III AS TOPIC; DATA INTERPRETATION, STATISTICAL; DOSE-RESPONSE RELATIONSHIP, DRUG; ENDPOINT DETERMINATION; HUMANS; MODELS, STATISTICAL; RESEARCH DESIGN; ROC CURVE; SAMPLE SIZE;

EID: 84864019962     PISSN: 02776715     EISSN: 10970258     Source Type: Journal    
DOI: 10.1002/sim.5326     Document Type: Article

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