电子源直接数据采集在肿瘤学研究者发起的临床试验中的效率。
Efficiency of eSource Direct Data Capture in Investigator-Initiated Clinical Trials in Oncology.
机构信息
Division of Biostatistics, Tohoku University Graduate School of Medicine, 1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8575, Japan.
A2 Healthcare Corporation, 1-4-12, Utsubohommachi, Nishi-Ku, Osaka, Japan.
出版信息
Ther Innov Regul Sci. 2024 Nov;58(6):1031-1041. doi: 10.1007/s43441-024-00671-0. Epub 2024 Jul 2.
BACKGROUND
Clinical trials have become larger and more complex. Thus, eSource should be used to enhance efficiency. This study aimed to evaluate the impact of the multisite implementation of eSource direct data capture (DDC), which we define as eCRFs for direct data entry in this study, on efficiency by analyzing data from a single investigator-initiated clinical trial in oncology.
METHODS
Operational data associated with the targeted study conducted in Japan was used to analyze time from data occurrence to data entry and data finalization, and number of visits to the site and time spent at the site by clinical research associates (CRAs). Additionally, simulations were performed on the change in hours at the clinical sites during the implementation of eSource DDC.
RESULTS
No difference in time from data occurrence to data entry was observed between the DDC and the transcribed data fields. However, the DDC fields could be finalized 4 days earlier than the non-DDC fields. Additionally, although no difference was observed in the number of visits for source data verification (SDV) by CRAs, a comparison among sites that introduced eSource DDC and those that did not showed that the time spent at the site for SDV was reduced. Furthermore, the simulation results indicated that even a small amount of data to be collected or a small percentage of DDC-capable items may lead to greater efficiency when the number of subjects per site is significant.
CONCLUSIONS
The implementation of eSource DDC may enhance efficiency depending on the study framework and type and number of items to be collected.
背景
临床试验变得越来越大且越来越复杂。因此，应使用电子源来提高效率。本研究旨在通过分析来自单个肿瘤学研究者发起的临床试验的数据，评估多站点实施电子源直接数据采集（DDC）对效率的影响，我们将其定义为直接数据输入电子 CRF。
方法
使用与在日本进行的目标研究相关的操作数据来分析数据发生到数据录入和数据定稿的时间，以及临床研究助理（CRA）到现场的访问次数和在现场花费的时间。此外，还对实施电子源 DDC 期间临床现场的时间变化进行了模拟。
结果
在数据发生到数据录入的时间方面，DDC 与转录数据字段之间没有差异。然而，DDC 字段可以比非 DDC 字段提前 4 天定稿。此外，虽然 CRA 对源数据验证（SDV）的访问次数没有差异，但对实施了电子源 DDC 的站点与未实施的站点进行比较显示，用于 SDV 的现场时间减少了。此外，模拟结果表明，即使是要收集的少量数据或具有 DDC 功能的项目的一小部分百分比，如果每个站点的受试者数量显著，也可能会提高效率。
结论
电子源 DDC 的实施可能会根据研究框架以及要收集的项目的类型和数量来提高效率。
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