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oapen-20.500.12657-493202021-11-23T13:50:47Z Chapter Evolving Roles of Spontaneous Reporting Systems to Assess and Monitor Drug Safety Cosimo Antonazzo, Ippazio Salvo, Francesco Raschi, Emanuel Pariente, Antoine Moretti, Ugo Poluzzi, Elisabetta De Ponti, Fabrizio pharmacovigilance, signal, spontaneous reporting system, disproportionality analysis bic Book Industry Communication::M Medicine::MB Medicine: general issues::MBN Public health & preventive medicine 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. 2021-06-02T10:12:06Z 2021-06-02T10:12:06Z 2019 chapter ONIX_20210602_10.5772/intechopen.79986_434 https://library.oapen.org/handle/20.500.12657/49320 eng application/pdf n/a 63595.pdf InTechOpen 10.5772/intechopen.79986 10.5772/intechopen.79986 09f6769d-48ed-467d-b150-4cf2680656a1 FP7-HEALTH-2009-single-stage 241679 open access
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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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