基于风险的质量管理:集中监控的一个案例
Nicole Stansbury1, Danilo Branco1, Cris McDavid1
1Association of Clinical Research Organizations (ACRO), 601 New Jersey Ave NW #350, Washington DC, 20001, USA.
Therapeutic innovation & regulatory science
|December 11, 2024
概括
临床试验中采用基于风险的质量管理 (RBQM) 显示了强烈的风险评估使用,但在其他领域落后. 集中式监测未得到充分利用,错失了改善患者安全和数据质量的机会.
科学领域:
- 临床研究是临床研究.
- 制药科学 制药科学
- 监管事务 监管事务
背景情况:
- 临床研究组织协会自2019年以来一直在调查基于风险的质量管理 (RBQM) 的采用情况.
- 报告介绍了四年的调查数据,包括7个CRO的4958项试验的2022年结果.
- 2022年调查的重点是1004个新的临床试验开始.
研究的目的:
- 分析临床试验中RBQM元素的采用趋势.
- 在最初的风险评估之外,识别RBQM实施中的差距.
- 倡导更多地利用集中监控和质量容忍限值 (QTL).
主要方法:
- 对RBQM采用的四年景观调查数据的分析.
- 专注于来自4958项临床试验的2022年调查数据.
- 开发一个案例研究,展示RBQM的实施.
主要成果:
- 整体风险评估的采用很强,但其他RBQM组件落后.
- 新研究开始显示,大多数RBQM元素的采用率接近50%.
- 尽管有潜在的好处,但集中式监控仍未得到充分利用.
结论:
- 由于实施不完整,公司可能无法充分受益于RBQM.
- 行业对质量容忍限度 (QTL) 的看法是不同的.
- 更多地采用集中监测对于高效和有效的临床试验至关重要.
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