Adapting the sample size planning of a phase III trial based on phase II data

Pharmaceutical Statistics

Volumn 5, Issue 2, 2006, Pages 85-97

  Wang, Sue Jane ^a   Hung, H M James ^b   O'Neill, Robert T ^a  

^a US Food and Administration   (United States)

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

Author keywords

Adaptation; Clinical endpoint; Effect size threshold; Launching probability; Phase II; Phase III; Surrogate endpoint; Uncertainty

Indexed keywords

DRUG; HEMOGLOBIN A1C; PLACEBO;

ACQUIRED IMMUNE DEFICIENCY SYNDROME; ANALYTICAL ERROR; ARTICLE; CANCER MORTALITY; CLINICAL RESEARCH; CONFIDENCE INTERVAL; CONTROLLED STUDY; DISEASE COURSE; DRUG RESEARCH; EFFECT SIZE; EXPERIMENTAL DESIGN; HUMAN; MONTE CARLO METHOD; NON INSULIN DEPENDENT DIABETES MELLITUS; PATHOGENESIS; PROBABILITY; SAMPLE SIZE; SHORT COURSE THERAPY; STATISTICAL ANALYSIS; TREATMENT DURATION; TREATMENT OUTCOME; TREATMENT PLANNING;

CLINICAL TRIALS, PHASE II; CLINICAL TRIALS, PHASE II AS TOPIC; CLINICAL TRIALS, PHASE III; CLINICAL TRIALS, PHASE III AS TOPIC; DATA INTERPRETATION, STATISTICAL; HUMANS; PROBABILITY; SAMPLE SIZE;

EID: 33745173819     PISSN: 15391604     EISSN: 15391612     Source Type: Journal    
DOI: 10.1002/pst.217     Document Type: Article

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