Bayesian predictive power for interim adaptation in seamless phase II/III trials where the endpoint is survival up to some specified timepoint

Statistics in Medicine

Volumn 26, Issue 27, 2007, Pages 4925-4938

  Schmidli, Heinz ^a   Bretz, Frank ^a   Racine Poon, Amy ^a  

^a NOVARTIS PHARMA AG   (Switzerland)

Author keywords

Adaptive design; Bayesian methods; Combination tests; Conditional power; Interim analysis; Operation characteristics; Piecewise exponential distribution; Predictive power; Two stage design

Indexed keywords

CORTICOSTEROID; CYCLOSPORIN; MYCOPHENOLIC ACID;

ACUTE GRAFT REJECTION; BAYES THEOREM; CLINICAL RESEARCH; CLINICAL TRIAL; CONFERENCE PAPER; CONTROLLED STUDY; DECISION MAKING; DRUG RESEARCH; HUMAN; IMMUNOSUPPRESSIVE TREATMENT; KIDNEY TRANSPLANTATION; METHODOLOGY; PREDICTION; SAMPLE SIZE; SURVIVAL; SYSTEMATIC ERROR;

BAYES THEOREM; CLINICAL TRIALS, PHASE II AS TOPIC; CLINICAL TRIALS, PHASE III AS TOPIC; ENDPOINT DETERMINATION; GRAFT REJECTION; HUMANS; IMMUNOSUPPRESSIVE AGENTS; IMMUNOTHERAPY; KIDNEY TRANSPLANTATION; MODELS, STATISTICAL; SURVIVAL ANALYSIS;

EID: 35948994165     PISSN: 02776715     EISSN: 10970258     Source Type: Journal    
DOI: 10.1002/sim.2957     Document Type: Conference Paper

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