ArticleAnnals of translational medicine2021
Analysis of the reasons for screening failure in phase I clinical trials in China: a retrospective study of the clinical trials screening process.
Article in Annals of translational medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
- A phase I COVID-19 vaccine trial among SARS-CoV-2 seronegative and seropositive individuals in Uganda utilizing a self-amplifying RNA vaccine platform: Screening and enrollment experiences.Human vaccines & immunotherapeutics · 2023Article
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Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTo analyze the main reasons for screening failure in the screening process of healthy subjects in phase I clinical trials and coping strategies.
methodsWe 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 (χ
resultsAmong 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
conclusionsBefore 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.
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