Oriana Ciani

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OBJECTIVE To quantify and compare the treatment effect and risk of bias of trials reporting biomarkers or intermediate outcomes (surrogate outcomes) versus trials using final patient relevant primary outcomes. DESIGN Meta-epidemiological study. DATA SOURCES All randomised clinical trials published in 2005 and 2006 in six high impact medical journals:(More)
The use of health technology assessment (HTA) to inform policy-making is established in most developed countries. Compared to licensing agencies, HTA agencies have different interests and, therefore, different evidence requirements. Criteria for coverage or reimbursement decisions on pharmaceutical compounds vary; however, it is common to include, as part(More)
OBJECTIVES The aim of this study was to review and compare current health technology assessment (HTA) activities for medical devices across non-European Union HTA agencies. METHODS HTA activities for medical devices were evaluated from three perspectives: organizational structure, processes, and methods. Agencies were primarily selected upon membership of(More)
Background Ideally, decisions on the value of health technologies should be based on evidence from well-conducted clinical trials that assess clinically important final patient-relevant outcomes, such as mortality or impaired quality of life. Pressure to reduce the delay in the availability of technologies to patients has led to an increased reliance on the(More)
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