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PageLayout: SinglePage PageMode: UseNone Language: en-US Outlines: Item: Title: Phase IV adaptive randomised clinical trials evaluating efficacy and cost-­efficacy of pre-­emptive pharmacogenetic genotyping strategies in the Spanish National Health System: iPHARMGx Master Protocol and PREVESTATGx nested clinical trial Children: Item: Title: Abstract Item: Title: Introduction Children: Item: Title: The iPHARMGx framework Item: Title: The PREVESTATGx Trial Item: Title: Methods and analysis Children: Item: Title: iPHARMGx: hypothesis and design Item: Title: Overarching iPHARMGx study objectives Item: Title: iPHARMGx study population and eligibility criteria Item: Title: PREVESTATGx study objectives Children: Item: Title: Primary objectives Item: Title: Secondary objectives Item: Title: Exploratory objectives Item: Title: Inclusion criteria Item: Title: Exclusion criteria Item: Title: Study procedures Children: Item: Title: Screening visit Item: Title: Baseline: up to 6 months after first screening visit Item: Title: Visit 3: 30 days after treatment initiation (±7 days window) Item: Title: Visit 4: 90 days after treatment initiation (±7 days window) Item: Title: Visit 5: 180 days after treatment initiation (±7 days window) Item: Title: Visit 6: 270 days after treatment initiation (±7 days window) Item: Title: Sample size calculation: efficacy and futility boundaries Item: Title: Randomisation and blinding Item: Title: Intervention Item: Title: Outcomes Children: Item: Title: Primary endpoint Item: Title: Secondary endpoints Item: Title: Exploratory endpoints Item: Title: Biological samples Item: Title: Statistical analysis Item: Title: Economic evaluation Item: Title: Data collection and outcome measures Item: Title: Patient and public involvement Item: Title: Ethics and dissemination Item: Title: Access to data Item: Title: Discussion Item: Title: References Info: Creator: Adobe InDesign 15.1 (Windows) Producer: Adobe PDF Library 15.0 CreationDate: Wed Nov 06 13:13:27 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