Flood Ann Barry, Bhattacharyya Shayan, Nicolalde R Javier, Swartz Harold M
Center for the Evaluative Clinical Sciences at Dartmouth, Dartmouth Medical School, Lebanon, NH USA.
Radiat Meas. 2007 Jul;42(6-7):1099-1109. doi: 10.1016/j.radmeas.2007.05.042.
Starting with the assumption that a device to detect unplanned radiation exposures is technically superior to current technology, we examine the additional stakeholders and processes that must be considered to move the device from the lab into use. The use is to provide reliable information to triage people for early treatment of exposure to ionizing radiation that could lead to the Acute Radiation Syndrome. The scenario is a major accident or terrorist event that leaves a large number of people potentially exposed, with the resulting need to identify those to treat promptly or not. In vivo EPR dosimetry is the exemplar of such a technique.Three major areas are reviewed: policy considerations, regulatory clearance, and production of the device. Our analysis of policy-making indicates that the current system is very complex, with multiple significant decision-makers who may have conflicting agendas. Adoption of new technologies by policy-makers is further complicated because many sources of expert input already have made public stances or have reasons to prefer current solutions, e.g., some may have conflicts of interest in approving new devices because they are involved with the development or adoption of competing techniques. Regulatory clearance is complicated by not being able to collect evidence via clinical trials of its intended use, but pathways for approval for emergency use are under development by the FDA. The production of the new device could be problematical if the perceived market is too limited, particularly for private manufacturers; for in vivo EPR dosimetry the potential for other uses may be a mitigating factor.Overall we conclude that technical superiority of a technique does not in itself assure its rapid and effective adoption, even where the need is great and the alternatives are not satisfactory for large populations. Many important steps remain to achieve the goals of approval and adoption for use.
从一种用于检测意外辐射暴露的设备在技术上优于现有技术这一假设出发，我们研究了为将该设备从实验室投入使用而必须考虑的其他利益相关者和流程。其用途是提供可靠信息，以便对人员进行分类，从而对可能导致急性放射综合征的电离辐射暴露进行早期治疗。设想的场景是发生重大事故或恐怖事件，导致大量人员可能受到辐射，因此需要确定哪些人应立即接受治疗，哪些人则不需要。体内电子顺磁共振剂量测定法就是这样一种技术的典范。本文回顾了三个主要领域：政策考量、监管审批以及设备生产。我们对政策制定的分析表明，当前系统非常复杂，有多个重要决策者，他们的议程可能相互冲突。政策制定者采用新技术的情况更加复杂，因为许多专家意见来源已经表明了公开立场，或者有理由倾向于现有解决方案，例如，一些人在批准新设备时可能存在利益冲突，因为他们参与了竞争性技术的开发或采用。由于无法通过对其预期用途进行临床试验来收集证据，监管审批变得复杂，但美国食品药品监督管理局（FDA）正在制定紧急使用的审批途径。如果预期市场过于有限，尤其是对私营制造商而言，新设备的生产可能会出现问题；对于体内电子顺磁共振剂量测定法来说，其他潜在用途可能是一个缓解因素。总体而言，我们得出结论，即使需求巨大且现有替代方案无法满足大量人群的需求，一项技术的技术优势本身并不能确保其迅速有效地被采用。要实现批准和投入使用的目标，仍有许多重要步骤要走。
