Objective:To discuss ethical review and management of serious adverse events in anti-tumor drug clinical trials in a grade A tertiary cancer hospital for timely and effective protection of subjects.Methods:The main contents and ethical management of ethical review on serious adverse events were retrospectively analyzed including the number, distribution rules, and whether they were reported in time in clinical trials conducted in our hospital in 2021.Results:A total of 1 789 serious adverse events in 259 clinical trials were reported, with more male subjects than female, with an average age of 59.95 years, mainly concentrated in the 50~59 age and 60~69 age groups, accounting for 27.45% and 42.37% respectively. Digestive oncology department, thoracic oncology department and renal cancer melanoma department ranked in the top three for the number of clinical trials and reports of serious adverse events. The highest incidence of serious adverse events was hospitalization at 63.44% and the lowest incidence was disability at 0.39%. The highest proportion of serious adverse events possibly related to clinical trials was 35.72%. Expected serious adverse events accounted for 65.85% versus 34.15% unexpected ones, and the difference between different correlations of serious adverse events whether they were expected or not.was statistically significant. Among the measures taken by the investigator for the test drugs due to serious adverse events, drug discontinuation was the most, accounting for 42.54%, while 3.07% of the trial plans modified the study protocol/informed consent. Serious adverse events reported within 24 hours accounted for 87.20%, and those reported in 24 hours and beyond accounting for 12.80%. A statistically significant difference of the reporting time between the registered and investigator initiated clinical trials was observed.Conclusions:The ethics committee should attach importance to ethical review and management of serious adverse events, pay attention to whether they were reported timely and accurately, strengthen supervision, and effectively protect the safety and interests of the subjects.

Drug clinical trials need to recruit suitable subjects to verify the safety and effectiveness of new drugs. Subject recruitment is a very important and challenging link in the whole process of drug clinical trials, and even directly affects the progress and final results of the trials. The medical ethics committee should give full play to the important function of ethical review, carefully review the whole process of subject recruitment from the perspective of science and ethics, and do a good job in the protection of the health and rights of subjects. This paper mainly discussed the basic principles of subject recruitment, the main problems existing in the recruitment process and the key contents of ethical review, so as to provide scientific references and suggestions for standardizing subject recruitment, protecting the rights and interests of subjects, and promoting the efficient and high-quality completion of drug clinical trials.

Humans ; Consensus ; Liver Neoplasms/therapy* ; China

Objective:To analyze ethical management of subjects′ complaints in drug clinical trials in a cancer hospital.Methods:A retrospective analysis of the complaints of subjects received and properly handled by the ethics committee through telephone, e-mail and on-site reception during the drug clinical trial in our hospital. Case studies were conducted to analyze the reasons for the occurrence of some particular subjects′ complaints, processing procedures and resolution processes.Results:The number of subjects' complaints in clinical trials in our hospital decreased year by year. The ethics committee of our hospital would check it immediately and review it carefully after receiving the subjects′ complaints, and return the review decisions to the subjects and researchers, at the same time, follow up with board meeting report and documentation. Regarding to the reasons of the subject complaint, mainly identified were the failure to participate in clinical trials due to inclusion and exclusion criteria, withdraw by investigators due to safety concerns, and not satisfied with the compensation.Conclusions:When receiving subjects′ complaints, the ethics committee should manage them seriously, verify the reasons in time and follow up properly, act as a communication bridge between subjects, researchers and sponsors, try their best to resolve subjects′ complaints, and protect the rights and interests of subjects.

The outbreak of major infectious diseases such as COVID-19 are unpredictable. In order to prevent the rapid spread of the epidemic, it is necessary to quickly start the first-class response to public health emergencies, take prevention and control measures such as isolating confirmed patients, suspected cases and close contacts, tracking their activity tracks, and publishing their infection related information, which may cause the leakage of personal privacy and information. Take preventive and control measures, which needs to protect the public interests while taking into account individual rights and interests, including privacy protection, and obtaining public understanding and support. The ethical governance of personal privacy protection in the prevention and control of major infectious diseases needs to regulate the use of personal information according to laws and regulations, achieve effective ethical governance in multiple dimensions, establish and improve the supervision and management mechanism of personal privacy protection, enhance the privacy protection awareness of relevant departments and staff, increase the punishment for illegal acts, strengthen science popularization, promote public understanding, and improve the efficiency and effectiveness of prevention and control.

Objective:To investigate the feasibility and safety of right-sided abdominal evisceration in retroperitoneal liposarcoma.Methods:The clinical data of 16 cases of retroperitoneal liposarcoma performed with right-sided abdominal evisceration at Sarcoma Center of Peking University Cancer Hospital from Sep 2015 to Feb 2019 were analyzed retrospectively.Results:Complete resection were successfully performed in all 16 cases.The median tumor size was 29cm(13-43 cm), the median operative time was 660 min(429-940 min), the median estimated blood loss was 2 000 ml(300-6 000 ml). The major postoperative complications rate (Clavien-Dindo classification Ⅲ-Ⅴ) was 38%. Median overall survival is 41.0 months while the median disease-free survival is 32.6 months.Conclusions:Right-sided abdominal evisceration is a favorable procedure to attain complete resection with acceptable complication rate.

Desmoid-type fibromatosis (DF) is a rare monoclonal fibroblastic proliferation that is characterized by locally infiltrative but rarely metastatic lesions. Tyrosine kinase and γ-secretase inhibitors are primarily used in the targeted therapy of DF. The use of these drugs, however, is mainly based on the recommendations of retrospective studies with small sample sizes. Previous studies that focused on the mechanism, efficacy, and safety of targeted therapy for DF were reviewed to provide references for clinical applications and research. The efficacy and safety of targeted therapy were compared with those of other systemic therapy options. Targeted therapy does not provide considerable advantages in efficacy and safety over other medical treatments and is usually applied after the failure of antihormonal therapies, nonsteroidal anti-inflammatory drugs, and chemotherapy. Further studies are required to explore the mechanism, indications, and appropriate drug dosage of the targeted therapy of DF.

Objective: To summarize the characteristics of abdominal-pelvic unplanned reoperation (URO) in a cancer hospital. Methods: Retrospectively descriptive cohort research was adopted. The classification of diseases was based on ICD-10, and surgical classification was based on ICD-9-CM-3. Medical record summary database from 2008 to 2018 in Beijing Cancer Hospital was collected, and all URO information of abdominal-pelvic surgery was retrieve. The time of URO, disease type, surgery type and cause were statistically analyzed. Distribution of main disease incidence and constituent ratio, and the application of major surgery and surgery type composition ratio were analyzed as well. Results: From 2008 to 2018, a total of 46854 cases underwent abdominal-pelvic surgery (including gastrointestinal, hepatic-biliary-pancreatic, gynecological, urological, or esophageal cancer surgery) and 713 patients received URO (1.52%), including 486 males and 227 females (2.14:1.00) with a mean age of (58.1±12.2) years. A total of 246 patients (34.50%) had comorbidity, and with comorbidity: without comorbidity was 1.13:1.00. The hospital stay was (44.5±43.0) days, and the total cost was (178000±112000) yuan. There were 22 deaths (3.09%). The median interval between URO and the first operation was 8 (0 to 131) days. The highest rate of URO was 2.45% (89/3629) in 2012, while the lowest was 0.95% (53/5596) in 2015. The top 3 major cancer types of URO included colorectal cancer (222 cases, 31.14%), gastric cancer (166 cases, 23.28%) and esophageal cancer (45 cases, 6.31%). The cancer types with the highest URO rate included pancreatic cancer (3.97%, 30/756), gastric cancer (1.81%, 166/9171) and colorectal cancer (1.80%, 222/12333). The top 3 surgical procedures resulting in URO were rectal resection (109 cases, 15.29%), total gastrectomy (79 cases, 11.08%), and total pancreatectomy (64 cases, 8.98%). Focusing on 497 URO cases from 2012 to 2018, 465 cases (93.56%) followed relatively difficult grade III and IV surgery, while only 32 cases (6.44%) followed grade I and II surgery. The top 5 main causes of URO were bleeding (225 cases, 31.56%), anastomotic leak (225 cases, 31.56%), infection (89 cases, 12.48%), intestinal obstruction (53 cases, 7.43%), and wound dehiscence (35 cases, 4.91%), adding up to a total of 87.94% of all URO. Conclusion This study summarizes the epidemiology of abdominal - pelvic URO in our cancer institution, providing the solid baseline for future investigation of URO and the subsequent formulation of corresponding prevention and intervention measures.

Objective To discuss appropriate strategies of site visits in ethical committees ,to enhance the supervision of clinical trials effectively ,and standardize the implementation of clinical research .Methods In consideration of the lack of de-tailed normative description of site visit in ethical guidelines and relevant articles ,as well as the varying degrees of implementa-tion and understanding of site visits among different ethical committees .This article discussed the procedures ,contents and considerations of site visit based on the analysis of numerous site visits cases conducted .Results Site visit is one of the crucial procedures to more comprehensive ,in-depth and truly understanding of the implementation of clinical trials .It is helpful to help sponsors/investigators enhance awareness and compliance with the good clinical practice .It also helps to correct problems time-ly during the implementation process to assure the standardized implementation of follow-up studies ,and finally ,effectively protect the rights and interests and safety of subjects .Conclusions Standardized and efficient site visit strategy of the ethical committee is one of the important regulatory strategies in the implementation of clinical trials and is an effective supplement to the regular review of ethical materials .

Objective To summarize the characteristics of abdominal?pelvic unplanned reoperation (URO) in a cancer hospital. Methods Retrospectively descriptive cohort research was adopted. The classification of diseases was based on ICD?10, and surgical classification was based on ICD?9?CM?3. Medical record summary database from 2008 to 2018 in Beijing Cancer Hospital was collected, and all URO information of abdominal?pelvic surgery was retrieve. The time of URO, disease type, surgery type and cause were statistically analyzed. Distribution of main disease incidence and constituent ratio, and the application of major surgery and surgery type composition ratio were analyzed as well. Results From 2008 to 2018, a total of 46854 cases underwent abdominal?pelvic surgery (including gastrointestinal, hepatic?biliary?pancreatic, gynecological, urological, or esophageal cancer surgery) and 713 patients received URO (1.52%), including 486 males and 227 females (2.14: 1.00) with a mean age of (58.1 ± 12.2) years. A total of 246 patients (34.50%) had comorbidity, and with comorbidity: without comorbidity was 1.13: 1.00. The hospital stay was (44.5 ± 43.0) days, and the total cost was (178000 ± 112000) yuan. There were 22 deaths (3.09%). The median interval between URO and the first operation was 8 (0 to 131) days. The highest rate of URO was 2.45% (89/3629) in 2012, while the lowest was 0.95% (53/5596) in 2015. The top 3 major cancer types of URO included colorectal cancer (222 cases, 31.14%), gastric cancer (166 cases, 23.28%) and esophageal cancer (45 cases, 6.31%). The cancer types with the highest URO rate included pancreatic cancer (3.97%, 30/756), gastric cancer (1.81%, 166/9171) and colorectal cancer (1.80%, 222/12333). The top 3 surgical procedures resulting in URO were rectal resection (109 cases, 15.29%), total gastrectomy (79 cases, 11.08%), and total pancreatectomy (64 cases, 8.98%). Focusing on 497 URO cases from 2012 to 2018, 465 cases (93.56%) followed relatively difficult grade III and IV surgery, while only 32 cases (6.44%) followed grade I and II surgery. The top 5 main causes of URO were bleeding (225 cases, 31.56%), anastomotic leak (225 cases, 31.56%), infection (89 cases, 12.48%), intestinal obstruction (53 cases, 7.43%), and wound dehiscence (35 cases, 4.91%), adding up to a total of 87.94% of all URO. Conclusion This study summarizes the epidemiology of abdominal?pelvic URO in our cancer institution, providing the solid baseline for future investigation of URO and the subsequent formulation of corresponding prevention and intervention measures.