ObjectivesSociety is confronted with the rapid emergence of innovation in science and technology. To manage this, horizon scanning is being adopted globally to identify, assess and prioritise innovations and trends at an early stage of their development. This enables decision-makers to be better informed and to prepare for change. The aim of this paper is to systematically identify and evaluate horizon scanning methodologies employed in the healthcare and biomedical fields.MethodsA systematic literature review was performed using PubMed and Embase and was supplemented with grey literature searches (2008–2018). The principal methodologies used in horizon scanning were extracted.ResultsApproximately 100 articles were summarised in a literature map. The search revealed many examples of horizon scanning across disciplines. Challenges, such as the need to refine prioritisation criteria, manage uncertainty inherent in the findings and improve the dissemination of identified issues, have been highlighted.ConclusionHorizon scanning, when performed appropriately, is a flexible and potentially reliable tool, with a wide variety of methods. Horizon scanning can inform and influence decision-making, through identifying opportunities and challenges, from an organisational to an international level. Further research to identify the most effective methodologies available would add depth to this landscape and enable the evolution of best practice to most efficiently anticipate novel developments and innovations.
The pace of innovation is accelerating, and so medicines regulators need to actively innovate regulatory science to protect human and animal health. This requires consideration and consultation across all stakeholder groups. To this end, the European Medicines Agency worked with stakeholders to draft its Regulatory Science Strategy to 2025 and launched it for public consultation. The responses to this consultation were analyzed qualitatively, using framework analysis and quantitatively, to derive stakeholders' aggregate scores for the proposed recommendations. This paper provides a comprehensive resource of stakeholder positions on key regulatory science topics of the coming 5 years. These stakeholder positions have implications for the development and regulatory approval of both human and veterinary medicines.
Background: An increasing number of medicines authorised in Europe recommend or require biomarker-based patient selection. For some of these the use of a companion diagnostic (CDx), a subset of in vitro diagnostics (IVDs), to identify patient populations eligible for a specific medicinal product may be required. The information and recommendations of use of a medicinal product for which a CDx is required is particularly important to healthcare professionals for correct patient identification.Methods: We reviewed the existing information in SmPCs and European Public Assessment Reports (EPARs) of EU medicinal products approved via the centralised procedure at EMA where reference was made to biomarker testing, including by CDx, for patient selection.Results: The results show that varying levels of detail are provided for the biomarker and the diagnostic test, including variability in where the information was presented. The overall results demonstrate transparent but sometimes heterogeneous reporting of CDx in the SmPC and EPAR.Conclusions: With the introduction of the new Regulation (EU) 2017/746 on in vitro diagnostic medical devices, medicines regulatory authorities' will be required to be consulted during the review of CDx conformity assessment and so, there is opportunity for more consistent and transparent information on CDx to be provided in the SmPC and EPAR.
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