CIC 1414 (Clinical Investigation Center), INSERM, Rennes, France.
Clinical Pharmacology Department, CHU Rennes, Rennes, France.
Br J Clin Pharmacol. 2019 Dec;85(12):2784-2792. doi: 10.1111/bcp.14108. Epub 2019 Dec 14.
Monitoring risk-based approaches in clinical trials are encouraged by regulatory guidance. However, the impact of a targeted source data verification (SDV) on data-management (DM) workload and on final data quality needs to be addressed.
MONITORING was a prospective study aiming at comparing full SDV (100% of data verified for all patients) and targeted SDV (only key data verified for all patients) followed by the same DM program (detecting missing data and checking consistency) on final data quality, global workload and staffing costs.
In all, 137 008 data including 18 124 key data were collected for 126 patients from 6 clinical trials. Compared to the final database obtained using the full SDV monitoring process, the final database obtained using the targeted SDV monitoring process had a residual error rate of 1.47% (95% confidence interval, 1.41-1.53%) on overall data and 0.78% (95% confidence interval, 0.65-0.91%) on key data. There were nearly 4 times more queries per study with targeted SDV than with full SDV (mean ± standard deviation: 132 ± 101 vs 34 ± 26; P = .03). For a handling time of 15 minutes per query, the global workload of the targeted SDV monitoring strategy remained below that of the full SDV monitoring strategy. From 25 minutes per query it was above, increasing progressively to represent a 50% increase for 45 minutes per query.
Targeted SDV monitoring is accompanied by increased workload for DM, which allows to obtain a small proportion of remaining errors on key data (<1%), but may substantially increase trial costs.
监管指南鼓励临床试验中采用基于风险的监测方法。然而，需要解决靶向源数据核查（SDV）对数据管理（DM）工作量和最终数据质量的影响。
MONITORING 是一项前瞻性研究，旨在比较全 SDV（对所有患者的所有数据进行 100%核查）和靶向 SDV（仅对所有患者的关键数据进行核查），然后使用相同的 DM 程序（检测缺失数据和检查一致性）对最终数据质量、总体工作量和人员成本进行比较。
共收集了来自 6 项临床试验的 126 名患者的 137008 份数据，包括 18124 份关键数据。与使用全 SDV 监测过程获得的最终数据库相比，使用靶向 SDV 监测过程获得的最终数据库在整体数据上的残留错误率为 1.47%（95%置信区间，1.41-1.53%），在关键数据上的残留错误率为 0.78%（95%置信区间，0.65-0.91%）。与全 SDV 相比，靶向 SDV 每个研究的查询数量几乎多了 4 倍（平均值±标准差：132±101 与 34±26；P=0.03）。对于每个查询 15 分钟的处理时间，靶向 SDV 监测策略的总体工作量仍低于全 SDV 监测策略。从 25 分钟/查询开始，它会高于全 SDV 监测策略，并逐渐增加到 45 分钟/查询时增加 50%。
靶向 SDV 监测会增加 DM 的工作量，从而使关键数据上的残留错误比例（<1%）略有下降，但可能会大幅增加试验成本。
