在临床结果评估中应用基于论证的方法验证:构建理由的策略
Kevin P Weinfurt1, R J Wirth2, Michael C Edwards3
1Center for Health Measurement, Department of Population Health Sciences, Duke University School of Medicine, Durham, North Carolina.
概括
本研究介绍了两种策略,以帮助研究人员建立有效的论点来解释临床结果评估 (COA) 评分,与FDA针对患者专注药物开发的指南保持一致.
科学领域:
- 临床试验方法论 临床试验方法论
- 监管科学是一种监管科学.
- 心理测量 心理测量 心理测量
背景情况:
- 美国食品和药物管理局的以患者为中心的药物开发指南促进了基于论证的方法来验证临床结果评估 (COA).
- 这种方法需要明确的理由来支持COA分数的解释.
- 研究人员和赞助商需要实用方法来构建这些验证理由.
研究的目的:
- 为研究人员和赞助商提供实用策略,为COA开发基于论证的验证理由.
- 为常见的COA类型提供初始的,通用的理由,以促进它们适应特定环境.
主要方法:
- 审查评估过程,以确定潜在的假设.
- 评估潜在的有效性威胁,包括构建代表性不足和不相关性.
- 为患者报告的结果 (PROs),观察者报告的结果 (ObsROs),临床医生报告的结果 (ClinROs) 和绩效结果 (PerfO) 措施制定通用理由.
主要成果:
- 介绍了构建验证参数的两个互补的策略.
- 为四种类型的COA提供了最初的通用理由.
- 这些理由旨在作为适应特定环境的起点.
结论:
- 提出的策略和通用理由可以帮助建立COA的强有力的验证论据.
- 需要进一步讨论,以建立关于构建和评估基于证据的理由的共识.
- 验证是一个代的过程,需要持续关注务实考虑.
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