为什么语言在数字终端开发中很重要:协调术语作为证据生成的关键前提
Lada Leyens1, Carrie A Northcott2, Lesley Maloney3
1Product Development Regulatory, Hoffmann-La Roche, Basel, Switzerland.
Digital biomarkers
|January 15, 2024
概括
全球药物开发需要数字健康措施的标准化术语. 对准的词汇对于监管的接受和在研究中一致使用数字终点至关重要.
科学领域:
- 数字卫生技术数字卫生技术
- 监管科学 监管科学
- 临床试验终点临床试验终点
背景情况:
- 越来越多地在药物开发中使用数字测量和数字衍生终点,需要全球协调的方法.
- 监管机构和医疗技术评估 (HTA) 机构的接受对于决策至关重要.
- 在全球药物开发中,共同的语言和一致的概念对于最大限度地提高数字措施的价值至关重要.
研究的目的:
- 审查在制药行业内推进数字终点方面的挑战.
- 突出需要一个共同的词典来解决不一致的术语和定义.
- 倡导标准化,以改善监管和付款人的协调和接受.
主要方法:
- 由EFPIA数字终端联合小组对数字终端领域当前挑战和术语的审查.
- 对"监控"",电子"与"数字"以及"原始"数据等术语的不一致性进行分析.
主要成果:
- 由于数字健康技术和衍生数据的各种术语和定义存在重大混乱.
- 不同的监管机构对"监控"等常见术语的解释不同.
- 使用"e"来表示电子与"数字"产生了模两可.
结论:
- 迫切需要一个一致的词典来标准化数字终端的开发,验证和使用.
- 标准化将促进这个快速发展的研究领域的一致性.
- 通过一种共同的语言,监管机构和付款人将加强协调和接受.
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