Graziadio Sara, Winter Amanda, Lendrem B Clare, Suklan Jana, Jones William S, Urwin Samuel G, O'Leary Rachel A, Dickinson Rachel, Halstead Anna, Kurowska Kasia, Green Kile, Sims Andrew, Simpson A John, Power H Michael, Allen A Joy
NIHR Newcastle In Vitro Diagnostics Co-operative, The Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, NE1 4LP, UK.
NIHR Newcastle In Vitro Diagnostics Co-operative, Room M2.088, Translational and Clinical Research Institute, William Leech Building, Medical School, Newcastle University, Newcastle NE2 4HH, UK.
Micromachines (Basel). 2020 Mar 10;11(3):291. doi: 10.3390/mi11030291.
Bringing a diagnostic point of care test (POCT) to a healthcare market can be a painful experience as it requires the manufacturer to meet considerable technical, financial, managerial, and regulatory challenges. In this opinion article we propose a framework for developing the evidence needed to support product development, marketing, and adoption. We discuss each step in the evidence development pathway from the invention phase to the implementation of a new POCT in the healthcare system. We highlight the importance of articulating the value propositions and documenting the care pathway. We provide guidance on how to conduct care pathway analysis as little has been published on this. We summarize the clinical, economic and qualitative studies to be considered for developing evidence, and provide useful links to relevant software, on-line applications, websites, and give practical advice. We also provide advice on patient and public involvement and engagement (PPIE), and on product management. Our aim is to help device manufacturers to understand the concepts and terminology used in evaluation of diagnostics (IVDs) so that they can communicate effectively with evaluation methodologists, statisticians, and health economists. Manufacturers of medical tests and devices can use the proposed framework to plan their evidence development strategy in alignment with device development, applications for regulatory approval, and publication.
将即时检验（POCT）诊断产品引入医疗市场可能是一段痛苦的经历，因为这要求制造商应对诸多技术、财务、管理和监管方面的挑战。在这篇观点文章中，我们提出了一个框架，用于开发支持产品研发、营销和采用所需的证据。我们讨论了从发明阶段到在医疗系统中实施新的即时检验这一证据开发路径中的每一步。我们强调了阐明价值主张和记录诊疗路径的重要性。由于关于如何进行诊疗路径分析的相关文献较少，我们提供了这方面的指导。我们总结了为开发证据而需考虑的临床、经济和定性研究，并提供了相关软件、在线应用程序、网站的有用链接，还给出了实用建议。我们还就患者及公众参与和介入（PPIE）以及产品管理提供建议。我们的目的是帮助设备制造商理解体外诊断（IVD）评估中使用的概念和术语，以便他们能够与评估方法学家、统计学家和卫生经济学家进行有效沟通。医疗检测和设备制造商可以使用所提出的框架，根据设备开发、监管批准申请和发表情况来规划其证据开发策略。
