Abstract
Certain innovative technologies applied to medical product development require novel evaluation approaches and/or regulations. Horizon scanning for such technologies will help regulators prepare, allowing earlier access to the product for patients and an improved benefit/risk ratio. This study investigates whether citation network analysis and text mining of scientific papers could be a tool for horizon scanning in the field of immunology, which has developed over a long period, and attempts to grasp the latest research trends. As the result of the analysis, the academic landscape of the immunology field was identified by classifying 90,450 papers (obtained from PubMED) containing the keyword “immune* and t lymph*” into 38 clusters. The clustering was indicative of the research landscape of the immunology field. To confirm this, immune checkpoint inhibitors were used as a retrospective test topic of therapeutics with new mechanisms of action. Retrospective clustering around immune checkpoint inhibitors was found, supporting this approach. The analysis of the research trends over the last 3 to 5 years in this field revealed several candidate topics, including ARID1A gene mutation, CD300e, and tissue resident memory T cells, which shows notable progress and should be monitored for future possible product development. Our results have demonstrated the possibility that citation network analysis and text mining of scientific papers can be a useful objective tool for horizon scanning of life science fields such as immunology.
Highlights
The application of innovative technologies that would lead to a product of novel modality or mechanism of action is expected to be a potential new therapeutic or diagnostic tool for diseases
The topic of each cluster can be inferred based on the characteristic keywords with high term frequency-inverse cluster frequency (TF-inverse cluster frequency (ICF)) of each cluster, and the title and abstract of several papers that are most cited within each cluster
Cluster 10 might be associated with the role of helper T cells in the immune response, as the top keywords include “tfh” and “tcr.” Table 2 shows the variation in the median publication year of the papers in each cluster: 1984 for Cluster 4, 1997 for Cluster 7, and 2008–2012 for others
Summary
The application of innovative technologies that would lead to a product of novel modality or mechanism of action is expected to be a potential new therapeutic or diagnostic tool for diseases. Faculty of Pharmaceutical Sciences, Sanyo-Onoda City University, Sanyoonoda‐shi, Japan application of conventional development and evaluation concepts, regulatory frameworks, or both to innovative technologies are inappropriate. Early identification of innovative technologies with potential applications to medical products through horizon scanning would encourage regulatory authorities to establish new approaches to assess their quality, efficacy, and safety to advise developers and revise their regulations as needed. This could contribute to timely patient access and improve the benefit-to-risk ratio of the product [1]. The IHSI, a regulatory entity with participation from eight European countries developed the IHSI Joint Horizon Scanning Database to promote
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