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全新或重新利用:一种用于创新药物地平线扫描的新型分类系统。

New or repurposed: a novel classification system for the horizon scanning of innovative medicines.

作者信息

Fairbairn Ross, Akinbolade Sola, Coughlan Diarmuid, Ogunbayo Dapo, Meader Nick, Craig Dawn

机构信息

National Institute for Health and Care Research (NIHR) Innovation Observatory, Population Health Sciences Institute, Faculty of Medical Sciences, Newcastle University, Newcastle, UK.

Population Health Sciences Institute, Faculty of Medical Sciences, Newcastle University, Newcastle, UK.

出版信息

Int J Technol Assess Health Care. 2024 Dec 9;40(1):e71. doi: 10.1017/S0266462324004628.

Abstract

OBJECTIVES

It is vital that horizon scanning organizations can capture and disseminate intelligence on new and repurposed medicines in clinical development. To our knowledge, there are no standardized classification systems to capture this intelligence. This study aims to create a novel classification system to allow new and repurposed medicines horizon scanning intelligence to be disseminated to healthcare organizations.

METHODS

A multidisciplinary working group undertook literature searching and an iterative, three-stage piloting process to build consensus on a classification system. Supplementary data collection was carried out to facilitate the implementation and validation of the system on the National Institute of Health and Care Research (NIHR) Innovation Observatory (IO)'s horizon scanning database, the Medicines Innovation Database (MInD).

RESULTS

Our piloting process highlighted important issues such as the patency and regulatory approval status of individual medicines and how combination therapies interact with these characteristics. We created a classification system with six values (New Technology, Repurposed Technology (Off-patent/Generic), Repurposed Technology (On-patent/Branded), Repurposed Technology (Never commercialised), New + Repurposed Technology (Combinations-only), Repurposed Technology (Combinations-only)) that account for these characteristics to provide novel horizon scanning insights. We validated our system through application to over 20,000 technology records on the MInD.

CONCLUSIONS

Our system provides the opportunity to deliver concise yet informative intelligence to healthcare organizations and those studying the clinical development landscape of medicines. Inbuilt flexibility and the use of publicly available data sources ensure that it can be utilized by all, regardless of location or resource availability.

摘要

目标

对于前沿扫描机构而言,获取并传播临床研发中新型药物和重新利用药物的情报至关重要。据我们所知,目前尚无用于获取此类情报的标准化分类系统。本研究旨在创建一种新颖的分类系统,以便将新型药物和重新利用药物的前沿扫描情报传播给医疗保健机构。

方法

一个多学科工作组进行了文献检索,并开展了一个迭代的三阶段试点过程,以就分类系统达成共识。还进行了补充数据收集,以促进该系统在英国国家卫生与保健研究机构(NIHR)创新观察站(IO)的前沿扫描数据库——药物创新数据库(MInD)上的实施和验证。

结果

我们的试点过程突出了一些重要问题,例如个别药物的专利状态和监管批准状态,以及联合疗法如何与这些特征相互作用。我们创建了一个具有六个值的分类系统(新技术、重新利用技术(专利过期/通用)、重新利用技术(专利有效/品牌)、重新利用技术(从未商业化)、新型+重新利用技术(仅联合疗法)、重新利用技术(仅联合疗法)),该系统考虑了这些特征,以提供新颖的前沿扫描见解。我们通过将该系统应用于MInD上的20000多条技术记录对其进行了验证。

结论

我们的系统为向医疗保健机构以及研究药物临床研发情况的人员提供简洁而信息丰富的情报提供了机会。其内在的灵活性以及对公开可用数据源的使用确保了无论身处何地或资源状况如何,所有人都能使用该系统。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2d07/11703622/c84e9d117222/S0266462324004628_fig1.jpg

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