Analysis of the reasons for screening failure in phase I clinical trials in China: a retrospective study of the clinical trials screening process

Li, Bin; Zhang, Qian; Liu, Yuanyuan; Zhang, Xiaolei; Cheng, Dongmei; Li, Aolin; Chen, Yubing; Zhu, Xingyu; Su, Yiyi; Zhou, Huan

doi:10.21037/atm-21-5010

Cited by 3 publications

(2 citation statements)

References 23 publications

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“…Our analysis showed that the total success ratio of 11 trials from 2018 to 2021 was only 27.8%, of which the highest was 38.5% and the lowest was only 18.2%, with an average of about 1/3. This is basically consistent with Li et al's research (13). Our screening success ratio was slightly higher than 21.8% of Wang's study in Josephine Ford Cancer Center (14).…”

Section: Discussionsupporting

confidence: 92%

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

Li¹,

Liu²,

He³

et al. 2022

Ann Palliat Med

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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 nonrandomization 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.

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Section: Discussionsupporting

confidence: 92%

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

Li¹,

Liu²,

He³

et al. 2022

Ann Palliat Med

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“…There is a suggestion that grading alone should not exclude participants from research participation without considering clinical significance. 23 Another key issue to consider is that this study used the FDA toxicity grading scale, 12 whose ranges may not be perfectly suited to this population. A study previously carried out in Uganda showed that 83% of participants that had been excluded from a HIV vaccine trial would have been enrolled if local ranges had been considered.…”

Section: Discussionmentioning

confidence: 99%

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

Kitonsa,

Kamacooko,

Ruzagira

et al. 2023

Human Vaccines & Immunotherapeutics

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We report the screening and enrollment process for a phase I vaccine trial in Masaka, Uganda that investigated the safety and immunogenicity of a self-amplifying SARS-CoV-2 RNA vaccine amongst individuals with and without antibodies to SARS-CoV-2. Participant screening and enrollment were conducted between December 2021 and April 2022. Individuals were eligible if they were aged between 18 and 45 years, healthy, and never vaccinated against COVID-19. SARS-CoV-2 antibody status was determined using two point-of-care rapid tests, i.e. Multi G (MGFT3) and Standard Q (Standard Q COVID-19 IgM/IgG Plus). Data were entered and managed in OpenClinica. Analyses were performed and presented descriptively. A total of 212 individuals were screened and 43(20.3%) enrolled. The most common reasons for exclusion were ≥ grade 1 laboratory abnormalities (39, 18.4%), followed by discordant SARS-CoV-2 antibody results (23, 10.9%). While the first 38 participants were quickly enrolled over a period of 9 weeks, it took another 9 weeks to enroll the remaining five, as antibody negative participants became scarce during the surge of the Omicron variant. The SARS-CoV-2 antibody positivity rate was determined to be 60.8% and 84.4% in each half of the 18 months of screening respectively. The mean age (±Standard Deviation, SD) of screened and enrolled participants was 27.7 (±8.1) and 30.2 (±8.3) years respectively. We demonstrated that it is feasible to successfully screen and enroll participants for COVID-19 vaccine trials in Uganda in the time of a pandemic. Our experiences may be useful for investigators planning to undertake similar work in Africa.

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Screen Failures in Clinical Trials in Retina

Hasan,

Mehrotra,

Danzig

et al. 2024

Ophthalmology Retina

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Analysis of the reasons for screening failure in phase I clinical trials in China: a retrospective study of the clinical trials screening process

Cited by 3 publications

References 23 publications

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

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

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

Screen Failures in Clinical Trials in Retina

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