Calaprice-Whitty Consulting, Inc., PO Box 2451, Blue Jay, CA, 92317, USA.
Mendel AI, San Jose, CA, USA.
Ther Innov Regul Sci. 2020 Jan;54(1):69-74. doi: 10.1007/s43441-019-00030-4. Epub 2020 Jan 6.
Delays in clinical trial enrollment and difficulties enrolling representative samples continue to vex sponsors, sites, and patient populations. Here we investigated use of an artificial intelligence-powered technology, Mendel.ai, as a means of overcoming bottlenecks and potential biases associated with standard patient prescreening processes in an oncology setting.
Mendel.ai was applied retroactively to 2 completed oncology studies (1 breast, 1 lung), and 1 study that failed to enroll (lung), at the Comprehensive Blood and Cancer Center, allowing direct comparison between results achieved using standard prescreening practices and results achieved with Mendel.ai. Outcome variables included the number of patients identified as potentially eligible and the elapsed time between eligibility and identification.
For each trial that enrolled, use of Mendel.ai resulted in a 24% to 50% increase over standard practices in the number of patients correctly identified as potentially eligible. No patients correctly identified by standard practices were missed by Mendel.ai. For the nonenrolling trial, both approaches failed to identify suitable patients. An average of 19 days for breast and 263 days for lung cancer patients elapsed between actual patient eligibility (based on clinical chart information) and identification when the standard prescreening practice was used. In contrast, ascertainment of potential eligibility using Mendel.ai took minutes.
This study suggests that augmentation of human resources with artificial intelligence could yield sizable improvements over standard practices in several aspects of the patient prescreening process, as well as in approaches to feasibility, site selection, and trial selection.
临床试验入组延迟和代表性样本入组困难仍然困扰着赞助商、研究点和患者群体。在这里,我们研究了使用人工智能驱动的技术 Mendel.ai 作为克服肿瘤学环境中标准患者预筛选过程相关瓶颈和潜在偏差的一种手段。
Mendel.ai 被追溯应用于在 Comprehensive Blood and Cancer Center 完成的 2 项肿瘤学研究(1 项乳腺癌,1 项肺癌)和 1 项未入组的研究(肺癌),允许在使用标准预筛选实践和 Mendel.ai 获得的结果之间进行直接比较。结果变量包括被认为有潜在资格的患者数量和从符合条件到识别出的时间。
对于每个入组的试验,使用 Mendel.ai 导致使用标准实践正确识别为潜在合格的患者数量增加了 24%至 50%。Mendel.ai 没有错过标准实践正确识别的患者。对于未入组的试验,两种方法都未能识别合适的患者。在使用标准预筛选实践时,乳腺癌患者的实际患者资格(基于临床图表信息)和识别之间平均间隔 19 天,而肺癌患者的间隔为 263 天。相比之下,使用 Mendel.ai 确定潜在资格只需几分钟。
这项研究表明,在患者预筛选过程的几个方面以及可行性、站点选择和试验选择的方法中,人工智能辅助人力资源可以比标准实践取得更大的改进。