Author(s): Banerjee AK, Ingate S
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Abstract Patient-reported outcomes (PROs) from web-based sources are becoming increasingly important, providing opportunities for industry and regulators to understand the benefits and risks of medicines in a real-world context. Although some guidance exists for the use of adverse event (AE) reports from company-sponsored social network sites, this does not cover non-company-sponsored sites. Additionally, there are concerns about the validity of data from social media sources. Techniques for the collection, analysis and reporting of safety data from patients should be defined, and guidelines agreed, to cover PROs and patient-reported adverse drug-related events from more organized sources of patient outcomes. This review considers drivers for web-based PRO adoption in drug safety, the current regulatory framework and potential methodologies, and concludes that there is an urgent unmet need for guidelines on web-based PRO AEs. Stakeholders for the development of any such guidance should include industry, patients, regulators, academic groups and prescribers.
This article was published in Drug Saf
and referenced in Journal of Microbial & Biochemical Technology