Chapter Evolving Roles of Spontaneous Reporting Systems to Assess and Monitor Drug Safety

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Tác giả: Ippazio Cosimo Antonazzo, Fabrizio De Ponti, Ugo Moretti, Antoine Pariente, Elisabetta Poluzzi, Emanuel Raschi, Francesco Salvo

Ngôn ngữ: eng

Ký hiệu phân loại:

Thông tin xuất bản: InTechOpen, 2019

Mô tả vật lý:

Bộ sưu tập: Tài liệu truy cập mở

ID: 242065

This chapter aims to describe current and emerging roles of spontaneous reporting systems (SRSs) for assessing and monitoring drug safety. Moreover, it offers a perspective on the near future, which entails the so-called era of Big Data, keeping in mind both regulator and researcher viewpoints. After a panorama on key data sources and analyses of post-marketing data of adverse drug reactions, a critical appraisal of methodological issues and debated future applications of SRSs will be presented, including the exploitation and challenges in evidence integration (i.e., merging and combining heterogeneous sources of data into a unique indicator of risk) and patient's reporting via social media. Finally, a call for a responsible use of these studies is offered, with a proposal on a set of minimum requirements to assess the quality of disproportionality analysis in terms of study conception, performing and reporting.
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