Rita Banzi
Mario Negri Institute for Pharmacological Research
Publications 79
To review the marketing authorization of biosimilars and provide a critical analysis of the pivotal trials supporting their approval by the European Medicines Agency (EMA). EMA website to identify the biosimilars approved up to July 2019 and the European Public Assessment Report for information on pivotal trial design, duration, intervention and control, primary outcome, data on immunogenicity, and comparability margins. The EMA has approved 55 biosimilars (62% in 2017–2019) of 16 biologic produ...
#1Lorenzo Moja (University of Milan)H-Index: 29
#2Hernan Polo FrizH-Index: 9
Last.Stefanos Bonovas (Humanitas University)H-Index: 9
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Importance Sophisticated evidence-based information resources can filter medical evidence from the literature, integrate it into electronic health records, and generate recommendations tailored to individual patients. Objective To assess the effectiveness of a computerized clinical decision support system (CDSS) that preappraises evidence and provides health professionals with actionable, patient-specific recommendations at the point of care. Design, Setting, and Participants Open-label, paralle...
#1Rita BanziH-Index: 15
#2Steve CanhamH-Index: 4
Last.Christian OhmannH-Index: 39
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Data repositories have the potential to play an important role in the effective and safe sharing of individual-participant data (IPD) from clinical studies. We analysed the current landscape of data repositories to create a detailed description of available repositories and assess their suitability for hosting data from clinical studies, from the perspective of the clinical researcher. We assessed repositories that enable storage, sharing, discoverability, re-use of the IPD and associated docume...
2 CitationsSource
#1Irene TramacereH-Index: 27
Last.Lorenzo Moja (University of Milan)H-Index: 29
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Statins may prevent recurrent ischemic events after ischemic stroke. Determining which statin to use remains controversial. We aimed to summarize the evidence for the use of statins in secondary prevention for patients with ischemic stroke by comparing benefits and harms of various statins. We searched for randomized controlled trials (RCTs) assessing statins in patients with ischemic stroke or transient ischemic attack (TIA) in MEDLINE, EMBASE, and CENTRAL up to July 2017. Two authors extracted...
2 CitationsSource
#1Vittorio BerteleH-Index: 19
#2Rita BanziH-Index: 15
Last.Silvio GarattiniH-Index: 62
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#1Silvia Minozzi (University of Milan)H-Index: 1
#2Michela Cinquini (Mario Negri Institute for Pharmacological Research)H-Index: 15
Last.Rita Banzi (Mario Negri Institute for Pharmacological Research)H-Index: 15
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Abstract Objective To assess the inter-rater reliability (IRR) and usability of the risk of bias in nonrandomized studies of interventions tool (ROBINS-I). Study Design and Setting We designed a cross-sectional study. Five raters independently applied ROBINS-I to the nonrandomized cohort studies in three systematic reviews on vaccines, opiate abuse, and rehabilitation. We calculated Fleiss' Kappa for multiple raters as a measure of IRR and discussed the application of ROBINS-I to identify diffic...
Background New direct-acting antiviral agents (DAAs) approved for the treatment of patients infected by Hepatitis C virus (HCV) are well tolerated and increase sustained virological response (SVR) rate. We summarize current evidence on the efficacy and safety from comparative randomized controlled trials (RCTs) of DAAs. Methods We systematically searched MEDLINE, Embase, Scopus, CENTRAL, and Lilacs as well as a list of reference literature. We included RCTs comparing DAAs with placebo or active ...