Qualitative Analysis of One Phase II Clinical Trial for the Drug Treatment of Large-Area Cerebral Infarction.

Purpose: Quality evaluation data for clinical trials of large-area cerebral infarction are lacking. The objective of this study was to identify critical quality control issues specific to clinical trials in large-area cerebral infarction and to propose and evaluate corresponding strategies for the improvement of related clinical trials. The findings aim to inform and enhance quality management practices in future trials within this clinical area.

Methods

Using one phase II clinical trial for the drug treatment of large-area cerebral infarction as the research model, we analysed the quality control issues in the participating centers. In the primary survey, quality issues were systematically examined from one key center (center A) and 26 additional centers participating in the trial. On the basis of the quality issues identified in the primary survey, six preventive measures were developed for these quality issues. These measures were subsequently applied in a follow-up secondary survey at two key centers (center A and center B); however, the other 53 centers were not subjected to the implementation of the measures. Chi-square analysis was conducted to evaluate the effectiveness of the corresponding preventive measures.

Results

In the primary survey, no statistically significant differences were observed in the incidence rates of issues between center A and other centers, with the exception of PD-related quality issues. Following the implementation of the preventive measures, chi-square analysis revealed a statistically significant reduction in AE-related issues at center A compared with the other centers (p < 0.05). The improvement in AE-related issues represents the most notable outcome of this study. The direct comparison within center A revealed a reduction in quality issues per subject from 9.42 in the primary survey to 5.93 in the secondary survey. In addition, the number of AE-related issues decreased from 4.58 per subject to 2.20 per subject.

Conclusions

The results of this study suggest that preventive measures are feasible for improving quality control in large-area cerebral infarction clinical trials. However, these quality measures require broader validation through larger-scale clinical trials.