Analysis of the reasons for screening failure in phase I clinical trials in China: a retrospective study of the clinical trials screening process.
Analysis of the reasons for screening failure in phase I clinical trials in China: a retrospective study of the clinical trials screening process.
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DOI：
10.21037/atm-21-5010
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发表时间：
2021-10
影响因子：
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通讯作者：
Zhou H
中科院分区：
文献类型：
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作者：
Li B;Zhang Q;Liu Y;Zhang X;Cheng D;Li A;Chen Y;Zhu X;Su Y;Zhou H
分析I期临床试验健康受试者筛选过程中筛选失败的主要原因及应对策略。我们回顾性收集了2019年4月至2020年7月在蚌埠医学院第一附属医院开展的12项I期临床试验中1，640例健康受试者的筛查过程数据。对筛选失败的原因进行统计学分析（χ2检验），并进行相关性研究，探讨与筛选失败相关的主要因素。在1,640例健康受试者中，632例（38.5%）成功通过筛选，1,008例（61.5%）筛选失败。实验室检查结果异常（43.25%）、生命体征检查结果异常（11.81%）、撤回知情同意（10.02%）、身高/体重检查结果异常（8.33%）、心电图（ECG）检查结果异常（5.66%）占筛选失败的79.07%。46-57岁受试者筛选失败的可能性高于18-30岁或31-45岁受试者（分别为158/220 vs. 541/893 vs. 309/527，P=0.002），男性筛选失败的可能性高于女性（分别为721/1，133 vs. 287/507，P=0.007）。但受试者居住地与临床试验机构的距离（P=0.491）与筛选失败无显著相关性。在试验筛选前，健康受试者应被告知临床试验风险，并有足够的时间考虑或与其家人讨论参与。此外，应告知受试者在筛选前应清淡饮食、充分休息并保持放松的心态。对于筛查过程中实验室指标和心电图检查报告正常范围的波动，临床医生应确定每项指标的医学决策水平（MDL）。如果未发现临床意义，则受试者可入选。在性别和年龄方面，本研究为进一步完善项目方案，提高健康受试者筛查成功率提供了合理化建议。
To analyze the main reasons for screening failure in the screening process of healthy subjects in phase I clinical trials and coping strategies. We retrospectively collected data from the screening process of 1,640 healthy subjects in 12 phase I clinical trials conducted between April 2019 and July 2020 at the First Affiliated Hospital of Bengbu Medical College. The reasons for screening failure were statistically analyzed (χ2 test), and correlation studies were conducted to explore the main factors associated with screening failure. Among the 1,640 healthy subjects, 632 (38.5%) successfully passed screening, and 1,008 (61.5%) failed screening. Abnormal laboratory test results (43.25%), abnormal vital sign examination results (11.81%), withdrawal of informed consent (10.02%), abnormal height/weight examination results (8.33%), and abnormal electrocardiogram (ECG) examination results (5.66%) accounted for 79.07% of the screening failures. Subjects aged 46–57 years were more likely to fail screening than those aged 18–30 or 31–45 years (158/220 vs. 541/893 vs. 309/527, respectively, P=0.002), and males were more likely than females to fail screening (721/1, 133 vs. 287/507, respectively, P=0.007). However, the distance between the subject’s residence and clinical trial institution (P=0.491) was not significantly correlated with screening failure. Before trial screening, healthy subjects should be informed of the clinical trial risks and have sufficient time to consider or discuss participation with their family members. In addition, subjects should be informed that they should eat lightly, have adequate rest, and maintain a relaxed state of mind prior to screening. Regarding fluctuations in the normal range of laboratory indicators and ECG examination reports during the screening process, clinicians should determine the medical decision level (MDL) for each indicator. If no clinical significance is identified, then the subject can be included. In terms of sex and age, this study provides reasonable suggestions to further improve project protocols and improve the healthy subject screening success rate.