{"id":7443,"date":"2019-07-28T15:50:50","date_gmt":"2019-07-28T15:50:50","guid":{"rendered":"https:\/\/eurekainfomed.it\/?p=7443"},"modified":"2026-07-28T14:35:51","modified_gmt":"2026-07-28T14:35:51","slug":"pharmacovigilance-as-transdisciplinary-scientific-discovery","status":"publish","type":"post","link":"https:\/\/eurekainfomed.it\/en\/pharmacovigilance-as-transdisciplinary-scientific-discovery\/","title":{"rendered":"Pharmacovigilance as transdisciplinary scientific discovery"},"content":{"rendered":"

One of the greatest challenges in pharmacovigilance is determining which of the many safety signals and pieces of evidence that emerge deserve further investigation and require an appropriate scientific and regulatory response. To address this challenge more effectively, it may be necessary to reconsider the way pharmacovigilance is viewed<\/strong>, redefining its epistemology as a science of exploration rather than one focused solely on determination and confirmation.<\/p>\n

\n

Identifying the potential risks associated with a medicinal product is fundamentally different from assessing its efficacy. While randomized clinical trials represent the most appropriate method for measuring the effects of a treatment in a target population, the same approach is often less effective for identifying potential risks. Safety issues are more frequently detected through anecdotal reports, case reports, and case series<\/strong>.<\/p>\n

Pharmacovigilance should therefore be regarded as an exploratory research activity centered on the concept of serendipity<\/strong>\u2014the occurrence of unexpected and valuable discoveries. Efforts within the scientific community should focus on building a responsive, flexible, and interactive community capable of maximizing opportunities for such discoveries<\/strong>.<\/p>\n

Foundations for more effective pharmacovigilance<\/h4>\n

In recent years, a significant amount of research has explored how the medical and scientific community could be reorganized to improve the generation, evaluation, and communication of safety information.<\/p>\n

Although the proposed solutions vary considerably, they generally focus on three key areas<\/strong>:<\/p>\n

    \n
  • creating networks that involve multiple stakeholders;<\/li>\n
  • incorporating different types of evidence;<\/li>\n
  • integrating the scientific method with the perspectives, interests, and contributions of diverse stakeholders.<\/li>\n<\/ul>\n

    Implementing these approaches could transform pharmacovigilance from a sequence of separate, additive processes\u2014where each phase of research is independent\u2014into a network of interactive processes, where information and activities are integrated across time, structure, and responsibilities.<\/p>\n

    How to maximize serendipitous discoveries: building a responsive community<\/h4>\n

    To encourage unexpected discoveries, it is essential to build a strong yet flexible scientific community capable of responding rapidly and appropriately to pharmacovigilance signals<\/strong>, thereby facilitating the transformation of chance observations into meaningful scientific findings.<\/p>\n

    The main characteristics of such a network are multidirectionality<\/strong>, a problem-centered approach<\/strong>, and transdisciplinarity<\/strong>.<\/p>\n

    Multidirectionality refers to the ability of the network to create an integrated environment in which information flows in multiple directions\u2014from a single observation to multiple discoveries, as well as from different observations toward the formulation of a single hypothesis.<\/p>\n

    Another crucial aspect is the ability of the various professionals involved in pharmacovigilance to combine different methods, expertise, and interests in order to focus on safety-related problems and determine which signals and observations warrant further investigation.<\/p>\n

    Finally, the network must be transdisciplinary, meaning that it should integrate the cultures, methods, and ideas of multiple fields<\/strong>, extending beyond scientific disciplines to include the perspectives of patients, policymakers, and other stakeholders.<\/p>\n

    Promoting the development of a responsive and effective pharmacovigilance network is undoubtedly a complex and long-term challenge<\/strong>. Such a transformation will require profound structural changes within the medical and scientific community, beginning with a shift in the education and training of future healthcare professionals and researchers.<\/p>\n

    Source<\/h4>\n

    Rocca E, Copeland S, Edwards IR. Pharmacovigilance as Scientific Discovery: An Argument for Trans-Disciplinarity<\/em>. Drug Safety. 2019. doi:10.1007\/s40264-019-00826-1.<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

    One of the greatest challenges in pharmacovigilance is determining which of the many safety signals and pieces of evidence that emerge deserve further investigation and require an appropriate scientific and…<\/p>\n","protected":false},"author":9,"featured_media":7447,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[25,4,1],"tags":[],"class_list":["post-7443","post","type-post","status-publish","format-standard","has-post-thumbnail","category-pharmacovigilance","category-news","category-uncategorized"],"yoast_head":"\nPharmacovigilance as transdisciplinary scientific discovery - Eureka Info Med<\/title>\n<meta name=\"description\" content=\"One of the key challenges in pharmacovigilance is determining which safety-related evidence warrants further investigation\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/eurekainfomed.it\/en\/pharmacovigilance-as-transdisciplinary-scientific-discovery\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Pharmacovigilance as transdisciplinary scientific discovery - 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