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Objective:To conduct a quantitative and qualitative analysis of the issues found in quality management, establish a risk-based whole-process quality management model, and improve the quality of clinical trials.Methods:Based on the risk-based quality management theory, the issues found in the quality control of drug clinical trials in Beijing Cancer Hospital in 2020 were structured and classified by severity (mild to moderate to severe) and 10 categories, and the risk matrix was graded by a semi-quantitative method. Targeted quality control strategies for different levels of risk were carried out according to visual analysis of the informative quality analysis platform. Chi-square tests of the severity of quality control issues in our hospital in 2020 and 2021 and non-parametric tests of the number of issues per capita in each category were used to evaluate the effectiveness of the management model.Results:A risk matrix was established according to the severity and frequency of the issues found in the quality control in 2020. The issues with severe risks were categorized as protocol compliance and serious adverse events, and categories with moderate risks included informed consent, biological sample related, original records, and investigator folders. After using visual analysis and adopting the risk-based quality control strategy, the proportion of severe issues found in quality control in our hospital in 2021 was 0.92%, lower than that of 1.39% in 2020, and the difference was statistically significant. The average number of issues detected per capita in each category for each trial in 2021 was lower than that in 2020 with a statistical difference, indicating that the management model was effective.Conclusions:Using information technology to adopt risk-based quality management is helpful to improve the quality of hospital clinical trials.
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Objective:To explore the management mode of the real-time reimbursement of testing expenses in clinical trials, dealing with the possible disadvantages of manual reimbursement and improving work efficiency.Methods:Based on hospital information system, the GCP center integrates the clinical trial information system, optimizes the trial reimbursement process, and explores a unique " clinic-GCP-finance" streamlined clinical trial real-time settlement management model.Results:This management mode of real-time reimbursement of testing expenses has been adopted for 3 years. This management model enables human subjects to complete the reduction or exemption of clinical trial-related medical testing expenses before making the payments, which is also highly praised by both investigators and subjects.It complied with informatization and technology development in the era of big data, realized full process dynamic supervision over clinical trial lab testing expenses and avoided management delay. It also had advantages in simplifying reimbursement process, reducing work load and mistakes, complying with inspection and improving trial quality.Conclusions:Clinical trial real-time reimbursement management mode of testing expenses works better in compliance with GCP, safeguards the rights and interest of human subject, and can provide a certain reference for other GCP centers.
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Objective:To describe the clinical characteristics , overall survival as well as to evaluate the prognostic factors in Chinese diffuse large B cell lymphoma ( DLBCL) patients.Methods: DLBCL pa-tients who were initially diagnosed and treated in Peking University Cancer Hospital from January 1995 to December 2008 were identified and analyzed ,retrospectively .The 5-year OS rates were estimated with Ka-plan-Meier.Log-rank test was used to compare the survival curves of the different groups .The multivari-ate analysis of prognostic factors was conducted with Cox regression model , which included all statistically significant prognostic factors in the univariate analyses .Results:A total of 525 DLBCL patients were in-cluded in this retrospective analysis , of whom , 294 were male and 231 female ( male∶female=1 .27∶1 ) . The median age at the initial diagnosis was 55 (range 16-90) years, and 37.0% (n=194) were 60 years and above .Regarding the clinical staging at the initial diagnosis , 54 patients (10.3%) were diag-nosed as Stage Ⅰ of the disease, 152 (28.9%) as Stage Ⅱ, 117 (22.3%) as Stage Ⅲ and 202 (38.5%) as Stage Ⅳ.The ‘B symptoms’ and increased serum LDH were presented in 206 (39.2%) and 192 (36.6%) patients, respectively.A total of 197 (37.5%) patients were treated with rituximab (R).The survival follow-up continued till 31 January 2014 with a median follow-up time of 77.5 ( range:0-205) months.A total of 267 patients (50.9%) died during the follow-up period.The medi-al overall survival ( OS) time was 84 months, and 5-year OS rate was 52.3%.There were six statistically significant prognostic factors that were identified in both univariate and multivariate analyses : gender, Ann Arbor stage, B symptom, serum LDH, age at initial diagnosis and rituximab treatment .The relative risk ( RR) of these prognostic factors in the multivariate analyses were: age >60 years /≤60 years=1.380 (95%CI 1.078 -1.765), male /female =1.315 (95%CI 1.025 -1.687), stage Ⅲ/stageⅠ=3.034(95%CI 1.667-5.522), stage Ⅳ/Ⅰ=3.748(95%CI 2.102 -6.681), with B symp-toms/without B symptoms=1.278(95%CI 0.999-1.636),serum LDH increased/LDH not increased=1.351(95%CI 1.057 -1.726), without R treatment /with R treatment =1.543(95%CI 1.182 -2 .015 ) .Compared with the IPI , age >50 years/≤50 years was a statistically significant factor in both univariate and multivariate analyses RR =1.478 (95%CI 1.148-1.902), P=0.002.Conclusion:Six factors were related to DLBCL survival:gender, Ann Arbor stage, B symptom, serum LDH, age at initial diagnosis and rituximab treatment .Compared with the IPI , several specific factors may predict a poor prognosis in Chinese DLBCL patients:male , age>50 years and the presence of ‘B symptoms ’ .But this result is not conclusive until these factors are further tested .