Optimal design and analysis of phase I/II clinical trials in multiple sclerosis with gadolinium-enhanced lesions as the endpoint

Multiple Sclerosis

Volumn 16, Issue 7, 2010, Pages 840-847

  Healy, Brian C ^a,b   Ikle, David ^c   MacKlin, Eric A ^b   Cutter, Gary ^d  

^a BRIGHAM AND WOMEN S HOSPITAL   (United States)

^b RHO INC   (United States)

^c MASSACHUSETTS GENERAL HOSPITAL   (United States)

^d UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

Author keywords

clinical trial design; disease modifying therapies; gadolinium enhanced lesions; MRI; multiple sclerosis; sample size calculation

Indexed keywords

GADOLINIUM; GLATIRAMER; CONTRAST MEDIUM;

ARTICLE; BINOMIAL DISTRIBUTION; COST EFFECTIVENESS ANALYSIS; HUMAN; MULTIPLE SCLEROSIS; NUCLEAR MAGNETIC RESONANCE IMAGING; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; POWER ANALYSIS; SIMULATION; STUDY DESIGN; BIOASSAY; COMPUTER ASSISTED DIAGNOSIS; COMPUTER SIMULATION; COST BENEFIT ANALYSIS; DIAGNOSTIC USE; ECONOMICS; HEALTH CARE COST; METHODOLOGY; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PREDICTIVE VALUE; REGRESSION ANALYSIS; STATISTICAL MODEL; TIME; TREATMENT OUTCOME;

CLINICAL TRIALS, PHASE I AS TOPIC; CLINICAL TRIALS, PHASE II AS TOPIC; COMPUTER SIMULATION; CONTRAST MEDIA; COST-BENEFIT ANALYSIS; ENDPOINT DETERMINATION; GADOLINIUM; HEALTH CARE COSTS; HUMANS; IMAGE INTERPRETATION, COMPUTER-ASSISTED; MAGNETIC RESONANCE IMAGING; MODELS, ECONOMIC; MULTIPLE SCLEROSIS; PREDICTIVE VALUE OF TESTS; REGRESSION ANALYSIS; RESEARCH DESIGN; TIME FACTORS; TREATMENT OUTCOME;

EID: 77955017469     PISSN: 13524585     EISSN: None     Source Type: Journal    
DOI: 10.1177/1352458510371409     Document Type: Article

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