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一项回顾性研究:I 期临床试验中 1058 例健康志愿者的筛查失败分析。

A retrospective study: screening failure analysis of 1,058 healthy volunteers in phase I clinical trials.

机构信息

Drug Clinical Trial Institution, Cangzhou Central Hospital, Cangzhou, China; First Department of Oncology, Cangzhou Central Hospital, Cangzhou, China.

Drug Clinical Trial Institution, Cangzhou Central Hospital, Cangzhou, China.

出版信息

Ann Palliat Med. 2022 Jul;11(7):2464-2477. doi: 10.21037/apm-22-767.

Abstract

BACKGROUND

Phase I clinical trials play an important role in the follow-up clinical trials and even the drug registration and marketing. However, the screening success ratio in phase I clinical trials is low, and the screening process of the trials consumes a significant amount of human and material resources, but the results are unsatisfactory. At present, there is no large sample data analysis for screening failure in phase I clinical trials. It is therefore urgent to find the reasons for screening failure in phase I clinical trials.

METHODS

A total of 1,058 healthy volunteers who failed the screening in 11 phase I clinical trials were retrospectively collected from October 2018 to June 2021 in Cangzhou Central Hospital. Data on all participants who failed screening for the study were analyzed (descriptive analysis) and reasons for their non-randomization were classified, as well as the differences of main screening failures between four years.

RESULTS

A total of 1,466 healthy volunteers were enrolled in the 11 trials, and among them 1,058 subjects failed the screening. The total screening success ratio of our study was only 27.8%, the highest being 38.5% and the lowest being 18.2%. The top 3 reasons for non-randomization were abnormalities in blood biochemistry tests (23.3%), vital sign examination (19.3%), and electrocardiogram (ECG) (16.6%). Abnormal blood biochemistry was the main reason between 2019 and 2021, except for 2018 in which it was the second reason.

CONCLUSIONS

Screening failure is a burdensome issue which various clinical trial sites must contend with. Investigators can still take some effective measures by strengthening the in-depth understanding of informed consent, paying attention to the quality of test samples, a correcting definition of no clinical significance (NCS). Also, low-cost and non-invasive examinations can be arranged first to better protect the volunteers and reduce the screening costs of clinical trials. To our delight, we find people's attention to the annual physical examination may help to screen healthy volunteers. Overall, this study shows that it is crucial and professional to develop a screening plan to minimize the resultant impact on timelines and budgets of phase I clinical trials enrolling healthy volunteers.

摘要

背景

Ⅰ期临床试验在后续临床试验乃至药物注册和上市中起着重要作用。然而,Ⅰ期临床试验的筛选成功率较低,试验筛选过程耗费大量的人力物力,但结果却不尽如人意。目前,对于Ⅰ期临床试验筛选失败尚无大样本数据的分析。因此,迫切需要寻找Ⅰ期临床试验筛选失败的原因。

方法

回顾性收集 2018 年 10 月至 2021 年 6 月沧州市中心医院 11 项Ⅰ期临床试验中筛选失败的 1058 例健康志愿者的资料。对所有筛选失败的研究参与者进行数据分析(描述性分析),对其非随机化的原因进行分类,并比较四年间主要筛选失败的差异。

结果

共纳入 11 项试验的 1466 例健康志愿者,其中 1058 例受试者筛选失败。本研究的总筛选成功率仅为 27.8%,最高为 38.5%,最低为 18.2%。非随机化的前 3 个原因是血液生化检查异常(23.3%)、生命体征检查异常(19.3%)和心电图(ECG)异常(16.6%)。血液生化异常是 2019 年至 2021 年的主要原因,除 2018 年外,它是第二个原因。

结论

筛选失败是各临床试验基地面临的一个沉重问题。研究者仍可以通过加强对知情同意的深入理解、关注检测样本的质量、纠正无临床意义(NCS)的定义等方式采取一些有效的措施。同时,可优先安排低成本、非侵入性的检查,以更好地保护志愿者,降低临床试验的筛选成本。令我们高兴的是,我们发现人们对年度体检的重视可能有助于筛选健康志愿者。总的来说,这项研究表明,制定筛选计划对于最大限度地减少对Ⅰ期临床试验招募健康志愿者的时间线和预算的影响至关重要。

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