Public HealthHealth InformaticsClinical Data ManagementEvidence-based PracticeMeta-analysisClinical Trial Data CollectionClinical TrialsRandomized Comparative TrialsRandomized Controlled TrialsSubgroup AnalysisTrial MonitoringAccess To Trial ResultsClinical Trial Data IntegrationInterim AnalysisMulticenter Trial Data ManagementRandomization ProceduresRandomized Clinical TrialsTreatment AllocationTreatment Outcome Analysis
Randomised or non-randomised treatment comparison * Blind or open treatment allocation and outcome assessment * Intention to treat or on-treatment analysis, or both * Sample size and duration of follow up * Subgroup analysis * Defined entry and exclusion criteria * Amount of data to collect on randomised and non-randomised but eligible patients * Defined outcomes * Widespread applicability of trial results; what to do about non-randomised but eligible patients * Interim analysis and the role of an independent data monitoring committee * How intensively to look for adverse effects of treatment * How intensively to monitor compliance * Computerisation of data * Sharing of original data with overview groups looking at similar treatments (meta-analysis) * Involvement with sponsoring company, if any.