Résumé
To ensure the rights and safety of the subjects and improve the quality of clinical trials, the author analyzed and discussed the deviation type and typical cases from 184 cases of protocol violation reviewed by the ethics committee in 56 clinical trials in a tertiary hospital in 2020. Among the 184 cases of violating the protocol, there were 29 major protocol violation cases and its proportion is 16%; 99 cases (54%) violated the GCP principle; 56 cases of other violations of the protocol that require to be reported, accounting for 30%. Through the case analysis of the researcher gave the wrong doses to subjects without following the protocol and drug administration did not conform to the rules, analyzed and discussed from the five perspectives of the research protocol design, the researcher, the clinical trial institution, the sponsor and the ethics committee, and put forward solutions and suggestions, so as to provide reference to improve the compliance of clinical trial protocol, reduce the risk of subjects and protect their rights and safety and ensure the successful progress of clinical trials.
Résumé
By collecting 475 protocol violation reports of pediatric clinical trials accepted by the ethics committee of a grade A tertiary hospital from January 2016 to December 2022, and conducting classification statistics of the responsible body, types of violation, and natures of violation, this paper analyzed and discussed the specific reasons and response measures for protocol violation. The results showed that the most common types of protocol violation included missed medication and incorrect medication dosage for pediatric research participants, missed laboratory inspection, over-windowed follow-up, and non-compliance with inclusion/exclusion criteria. And the responsibility bodies were pediatric research participants and/or their guardians, followed by the researchers. Besides, the sponsor, clinical trial coordinator, and other factors also contributed to protocol violation. Establishing awareness of responsible body, emphasizing subject management, building sound quality control system, and strengthening ethical supervision are the main countermeasures to prevent and reduce protocol violation in pediatric clinical trials, which helps to protect the safety and rights of pediatric research participants and promote standardized research in pediatric clinical trials.
Résumé
PURPOSE: In many other countries, based on research, recombinant tissue plasminogen activator (r-tPA) has been approved for the treatment of acute ischemic strokes. However, in Korea, little research has been done till now, in spite of using r-tPA widely. We sought to assess the feasibility and the efficacy of treatment and to evaluate the prognosis and complications at the violation of using r-tPA. Our study was compared with other previous studies. METHODS: A retrospective review is presented of 25 the cases of patients with acute ischemic stroke treated with rtPA according to the National Institutes of Neurological Disorders and Strokes (NINDS) protocol. We classified the groups by protocol violation (time, blood pressure, and computed tomography). We then analyzed neurologic outcomes by using the National Institutes of Health Strokes Scale (NIHSS) and complications based on whether or not intracerebral hemorrhage (ICH) had occurred. RESULTS: Of the 25 patients (mean age: 57 males: 19), 6 had time violation (onset time > 180 min), 4 had blood-pressure violation (systolic BP > 185 mmHg), 5 had CT violation (low density at initial CT). The NIHSS score improved in 64% of all patients after 24 hours. However, improvement was lower in the case of deviation present than it was in the case of deviation absent (time, blood pressure, and CT, respectively, 20%, 50%, and 40%; p-value respectively 0.0274, 0.8350, and 0.4125). ICH occurred in 6 cases, but in cases of deviation present, ICH occurred at a greater frequency. CONCLUSION: Our safety and feasibility of outcome compared favorably with NINDS and other previous studies. In addition, we confirmed that the presence of protocol deviation was associated a poor outcome.