Designing a seamless phase II/III clinical trial using early outcomes for treatment selection: An application in multiple sclerosis

Statistics in Medicine

Volumn 30, Issue 13, 2011, Pages 1528-1540

  Friede, T ^a   Parsons, N ^b   Stallard, N ^b   Todd, S ^c   Valdes Marquez, E ^c   Chataway, J ^d,e   Nicholas, R ^d  

^a UNIVERSITY MEDICAL CENTER GÖTTINGEN   (Germany)

^b UNIVERSITY OF WARWICK   (United Kingdom)

^c UNIVERSITY OF READING   (United Kingdom)

^d IMPERIAL COLLEGE HEALTHCARE NHS TRUST   (United Kingdom)

^e NATIONAL HOSPITAL FOR NEUROLOGY AND NEUROSURGERY   (United Kingdom)

Author keywords

Adaptive seamless design; Closed test procedure; Combination test; Short term endpoint; Surrogate endpoint

Indexed keywords

ARTICLE; CALCULATION; EFFECT SIZE; HUMAN; INTERMETHOD COMPARISON; METHODOLOGY; MULTIPLE SCLEROSIS; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PROBABILITY; SAMPLE SIZE; SIMULATION; STATISTICAL ANALYSIS; TREATMENT INDICATION;

ANTI-INFLAMMATORY AGENTS; CLINICAL TRIALS, PHASE II AS TOPIC; CLINICAL TRIALS, PHASE III AS TOPIC; COMPUTER SIMULATION; HUMANS; MODELS, STATISTICAL; MULTIPLE SCLEROSIS; RESEARCH DESIGN; TREATMENT OUTCOME;

EID: 79956063286     PISSN: 02776715     EISSN: 10970258     Source Type: Journal    
DOI: 10.1002/sim.4202     Document Type: Article

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