实施科学理论,模型和框架在药品实施研究中的使用:范围审查
Meredith Y Smith1,2, Bridget Gaglio3, Milena Anatchkova3
1Evidera, Inc., Bethesda, MD, United States of America. tantmieux57@gmail.com.
Health research policy and systems
|January 30, 2024
概括
药品的实施科学 (IS) 研究很少使用理论,模型和框架 (TMF). 观察到TMF的应用有限,突出显示需要在药物开发中更早地整合,以改善临床实践的采用.
科学领域:
- 医疗保健服务研究 医疗服务研究
- 实施科学 实施科学
- 制药政策 制药政策
背景情况:
- 弥合新的治疗证据和临床实践之间的差距至关重要.
- 实施科学 (IS) 研究旨在加速新药的采用.
- 药品信息化中的理论,模型和框架 (TMF) 的利用和质量尚未得到充分理解.
研究的目的:
- 在药品的IS研究中对TMFs的使用进行范围审查.
- 在药物实施研究中评估TMF应用的程度和性质.
主要方法:
- 对使用TMF的药物进行了IS研究的全面搜索.
- 1974年1月至2022年12月之间的出版物被选和抽象.
- 通过实施研究开发工具评估研究质量.
主要成果:
- 在2697个已识别的出版物中,只有9项研究符合纳入标准.
- 实施研究综合框架 (CFIR) 是最常用的TMF.
- TMF的应用有限,主要用于仪器开发和定性分析,需要患者参与和成本报告.
结论:
- 很少有涉及药物的IS研究明确报告TMF的使用.
- 现有的TMF使用往往是有限的,仅限于营销后阶段.
- 建议在整个药物开发过程中更早,更全面地整合TMF,以推进IS研究.
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