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Advances in novel drugs, therapies, and genetic techniques have revolutionized the diagnosis and treatment of cancers, substantially improving cancer patients' prognosis. Although rare tumors account for a non-negligible number, the practice of precision medicine and development of novel therapies are largely hampered by many obstacles. Their low incidence and drastic regional disparities result in the difficulty of informative evidence-based diagnosis and subtyping. Sample exhaustion due to difficulty in diagnosis also leads to a lack of recommended therapeutic strategies in clinical guidelines, insufficient biomarkers for prognosis/efficacy, and inability to identify potential novel therapies in clinical trials. Herein, by reviewing the epidemiological data of Chinese solid tumors and publications defining rare tumors in other areas, we proposed a definition of rare tumor in China, including 515 tumor types with incidences of less than 2.5/100 000 per year. We also summarized the current diagnosis process, treatment recommendations, and global developmental progress of targeted drugs and immunotherapy agents on the status quo. Lastly, we pinpointed the current recommendation chance for patients with rare tumors to be involved in a clinical trial by NCCN. With this informative report, we aimed to raise awareness on the importance of rare tumor investigations and guarantee a bright future for rare tumor patients.
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Humans , Neoplasms/pathology , Biomarkers , Prognosis , Oceans and Seas , China/epidemiologyABSTRACT
@#At the end of 2022, the National Medical Products Administration (NMPA), in conjunction with the National Cancer Center, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College raised for the first time the important issue of clinical research globally: whether the source of the death time of clinical trials based on the simple follow-up records is credible, and proposed a consensus document on the source of the death time of clinical trials. The results were published in The Lancet Regional Health-Western Pacific, which attracted wide attention and recognition from the international industry. This is the first time that the China consensus on quality standards for clinical research has been ahead of the U.S. Food and Drug Administration and other international colleagues. The NMPA has been leading China in promoting the scientific development of clinical research, so as to constantly establish and improve the scientific regulatory system and ecological system, and promote China's full integration into the global pharmaceutical research and development system. China clinical research institutions and the whole industry are also gradually from standardized development to scientific development, high-quality development process. In this study, we summarized the scientific and subject-oriented development of China clinical research industry in recent years, and continuously strengthened the international competitiveness of China pharmaceutical industry. It is suggested that scientific thinking model should be used to deal with the normative problems in clinical research and promote the development of medical model to scientific model.
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@#Objective To summarize the progress and trend on clinical drug trials of esophageal squamous cell carcinoma in China. Methods Based on the clinical drug trial registration and information disclosure platform and the drug data query system of the National Medical Products Administration, the characteristics of clinical trials, investigational drugs and listed drugs of esophageal squamous cell carcinoma in China from 2012 to 2021 were analyzed. Results From 2012 to 2021, a total of 49 clinical drug trials of esophageal squamous cell carcinoma were registered in China, accounting for 1.6% of all clinical trials of anticancer drugs. Among them, there were 39 (79.6%) trials initiated by domestic pharmaceutical enterprises, 6 (12.2%) for adjuvant and neoadjuvant treatment, and 9 (18.4%) for local treatment. There were differences in the treatment line distribution between global and domestic enterprise-initiated trials (P=0.032). The above trials covered 29 investigational drugs, including 23 (79.3%) targeted drugs, most of which targeted programmed death-1, programmed death-ligand 1 and epidermal growth factor receptor. From 2012 to 2021, there were 2 drugs for esophageal squamous cell carcinoma listed in China, both of which were approved for the first-line and second-line treatment. Conclusion Great achievements have been made in the clinical development of esophageal squamous cell carcinoma drugs in China. It is suggested that domestic enterprises increase the investment of esophageal squamous cell carcinoma, pay attention to adjuvant and local treatment, explore novel targets and drug categories, and focus on the details of pivotal trials.
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Objective:To deliver understanding of the latest research progress on clinical trials and approval of dermatological drugs in China in 2020.Methods:A registration and information disclosure platform for drug clinical studies and a query system for domestic and imported drugs in the National Medical Products Administration of China were searched for registered clinical trials and approved dermatological drugs, respectively. The number and stages of clinical trials, indications and classification of involved products, and listed dermatological drugs in 2020 were summarized and depicted.Results:There were 157 dermatological drug trials registered in China in 2020, accounting for 6.16% of all the 2 548 clinical drug trials, including 127 (80.9%) initiated by Chinese pharmaceutical enterprises and 25 (15.9%) international multicenter trials. Among the 127 drug trials initiated by Chinese pharmaceutical enterprises, bioequivalence trials were mostly common, accounting for 55.9% (71/127) . Compared with global pharmaceutical enterprises, domestic pharmaceutical companies initiated significantly decreased proportions of international multicenter trials (1.9% [3/157] vs. 14.0% [22/157], P < 0.001) , but significantly increased proportions of phaseⅠclinical trials and bioequivalence trials (24.4% [31/127] vs. 10.0% [3/30], 55.9% [71/127] vs. 0, respectively, both P < 0.001) . Totally, 90 kinds of dermatological drug were involved in all the trials, psoriasis, atopic dermatitis and melanoma were the most common indications, and innovative drugs accounted for 53.3% (48/90) ; the proportion of innovative drugs was significantly lower in domestic pharmaceutical companies than in global pharmaceutical companies (43.2% [32/74] vs. 16/16, P < 0.001) . In addition, 28 dermatological drugs developed by 22 pharmaceutical companies were approved in China in 2020, of which 21 drugs were developed by domestic pharmaceutical companies. Conclusion:Clinical drug trials carried out by domestic pharmaceutical companies mostly focus on generic drugs, and it is still necessary for domestic pharmaceutical companies to further improve the innovation ability.
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Objective@#To deliver macro understanding of the latest research progress on clinical trials and approved products of cancer drugs in China in 2019.@*Methods@#The number of clinical trials and related investigational products by domestic and foreign enterprises in 2019 were acquired in the China Food and Drug Administration Registration and Information Disclosure Platform for Drug Clinical Studies, while listed drugs were obtained in the China Food and Drug Administration Query System for Domestic and Imported Drug. Characteristics on stage, scope, indication of those trials, classification and mechanism of involved products, as well as listed anticancer drugs were summarized and depicted.@*Results@#There were 474 cancer drug trials registered in China in 2019, accounting for 21.8% of the total, and 397 (83.8%) were initiated by domestic pharmaceutical enterprises. Overall, international multicenter trials accounted for 13.1%, and phase I trials accounted for 47.3%. Compared with global enterprises, the proportion of international multi-center trials initiated by domestic companies is lower (4.8% vs. 55.8%, P<0.001), and the proportion of phase I clinical trials and bioequivalence trials is higher (51.9% vs. 23.4%, 19.4% vs. 1.3%, P<0.001). An accumulative of 27 cancer types were involved for all the cancer drug trials, and lung cancer, solid tumor, and breast cancer were the most common cancer types, with 103, 95 and 49 trials, respectively. For the three cancer types unique to Chinese population, gastric, liver and esophageal cancer, the total number of initiated trials was 47. For all those trials, there were 335 cancer drug varieties, with 86.0% developed by domestic pharmaceutical enterprises, including 300 therapeutic drugs, 30 adjunctive drugs and 5 preventive drugs. In terms of mechanism, targeted drugs and immune drugs were the most popular, accounting for 74.6% and 20.3%, respectively. In addition, 17 anticancer drugs targeting on 11 cancer types were approved in China in 2019.@*Conclusions@#Clinical trials on cancer drugs in China have ushered a booming era, with large number of innovative agents represented by targeted drugs and immune drugs under clinical development or putting into clinical practice. Those local enterprises are playing more and more critical roles. Strengthening clinical research and development on Chinese unique cancer types is the key direction of future work.
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The health literacy refers to the ability of individuals to acquire and understand basic health information and services and use them to make the right decisions to maintain and promote their health. Health literacy data focusing on cancer prevention and control was limited in China. In order to understand the health literacy and awareness of cancer risk factors and the cancer screening, early diagnosis and treatment in Chinese urban residents and compare the effect of different stages of the cancer intervention, the Cancer Screening Program in Urban China (CanSPUC) program, supported by the National Key Public Health Program, conducted a survey on the health literacy of the cancer prevention and treatment among urban residents in 16 provinces nationwide from 2015 to 2017. Four subgroups were designed in this survey, including (1) general population who have never participated in any cancer screening programs at a community-level; (2) individuals who have previously attended the CanSPUC program for cancer risk assessment or screening intervention; (3) cancer patients who were receiving treatment in local hospitals; (4) a special group from employees of government and public institutions (non-health system), state-owned enterprises and private enterprises (to have better understand on the impact of socioeconomic factors). The self-designed questionnaire covered six parts, including basic information, consciousness of common risk factors to cancer, awareness of early detection, awareness of early diagnosis, awareness of early treatment, and the needs and approaches for knowledge of cancer prevention and treatment. A total of 32 257 individuals were included in the final analyses. This paper landscaped the overall design of the survey, including participants, domains of the instrument, quality control, basic characteristics of the included individuals. These descriptions are applicable to each individual report of the current special issue of "Health Literacy of Cancer Control in Urban China" and future reports, in which more detailed results are and will be reported. The findings of this survey could provide some useful implications for similar researches in the future.
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Objective@#To investigate the demand and access to the cancer prevention and treatment knowledge and related factors among urban residents in China from 2015 to 2017.@*Methods@#A cross-sectional survey was conducted in 16 provinces covered by the Cancer Screening Program in Urban China from 2015 to 2017. A total of 32 257 local residents aged ≥18 years old who could understand the investigation procedure were included in the study by using the cluster sampling method and convenient sampling method. All local residents were categorized into four groups, which contained 15 524 community residents, 8 016 cancer risk assessment/screening population, 2 289 cancer patients and 6 428 occupational population, respectively. The self-designed questionnaire was used to collect the information of general demographic characteristics, the demand and access to cancer prevention and treatment knowledge, and the influencing factors of the attitude. The Chi-square test was used to analyze the difference of the demand of the cancer prevention knowledge among different groups and the corresponding factors of the cancer prevention and treatment knowledge were analyzed by using the logistic regression model.@*Results@#The proportion of residents who need the cancer prevention and treatment knowledge was 79.5%. The demand rate of the inducement, symptom and diagnosis methods of cancer in the occupational population was highest, about 66.8%, 71.0% and 20.8%, respectively. The demand rate of treatment methods and cost in current cancer patients was the highest, about the 45.9% and 21.9%, respectively. The top three sources to acquire the cancer prevention and treatment knowledge were "broadcast or television" (69.5%), "books, newspapers, posters or brochures" (44.7%) and "family and friends" (33.8%). The multivariate analysis showed that compared with public institution personnel/civil servants, unmarried/cohabiting/divorced/widowed and others, annual household income less than 20 000 CNY, from the eastern region, people without cancer diagnosis and people with self-assessment of cancer risk, the demand rate of cancer prevention and treatment knowledge was higher in enterprise personnel/workers, married, annual household income between 60 000 CNY and 150 000 CNY, from the central region, people with cancer and people with unclear cancer risk (all P values <0.05).@*Conclusion@#There was a high demand for the cancer prevention and treatment knowledge among urban residents in China from 2015 to 2017. The main access to the knowledge is from the radio or television. The occupation, marital status, annual household income, residential region, health status and risk of disease were the main factors of the demand of the cancer prevention and treatment knowledge.
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Objective@#To understand the health literacy of the cancer prevention and treatment among urban residents of China, and explore the related factors.@*Methods@#A cross-sectional survey was conducted in 16 provinces covered by the Cancer Screening Program in Urban China (CanSPUC) from 2015 to 2017. A total of 32 257 local residents aged ≥18 years old who could understand the investigation procedure were included in the study by using the cluster sampling method and convenient sampling method. All local residents were categorized into four groups, which contained 15 524 community residents, 8 016 cancer risk assessment/screening population, 2 289 cancer patients and 6 428 occupational population, respectively. The health literacy of the cancer prevention, early discovery, early diagnosis, early treatment and the demands of cancer prevention and treatment knowledge was analyzed. The level of health literacy among different groups were calculated and compared. The binary logistic regression model was used to analyze the influencing factors of the health literacy of the cancer prevention and treatment.@*Results@#The level of health literacy of the cancer prevention and treatment was 56.97% among all study population; in each group it was 55.01% for community residents, 59.08% for cancer risk assessment/screening population, 61.99% for cancer patients and 57.31% for occupational population, respectively (P<0.001). The level of health literacy of the cancer prevention and treatment of residents aged 50 to 69 years old, other occupational groups, unmarried, the central and western region residents and the group with unclear self-assessment of cancer risk was significantly lower than that of residents younger than 40 years old, personnel of public institutions/civil servants, married, the eastern region residents and the group whose self-assessment without cancer risk (P<0.05) . The level of health literacy of cancer prevention and treatment of females, people who went to high school or over, cancer risk assessment/screening population, cancer patients and occupational population was significantly higher than that of males, people who had an education level of primary school or below and community residents (P<0.05) .@*Conclusion@#The health literacy of the cancer prevention and treatment of urban residents in China was relatively high, but there was still room for improvement. Gender, age, educational level, occupation, region, marital status, self-assessment of cancer risk, and type of respondents were the key influencing factors of the health literacy of the cancer prevention and treatment. Male, 50-69 years old, lower educational level, central and western regions, unclear cancer risk self-assessment, and without specific environmental exposure to cancer prevention and treatment knowledge or related risk factors were the characteristics of the key intervention group of the health literacy of the cancer prevention and treatment.
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Objective@#To understand the consciousness of the cancer early treatment and its demographic and socioeconomic factors.@*Methods@#A cross-sectional survey was conducted in 16 provinces covered by the Cancer Screening Program in Urban China (CanSPUC) from 2015 to 2017. A total of 32 257 local residents aged ≥18 years old who could understand the investigation procedure were included in the study by using the cluster sampling method and convenient sampling method. All local residents were categorized into four groups, which contained 15 524 community residents, 8 016 cancer risk assessment/screening population, 2 289 cancer patients and 6 428 occupational population, respectively. The questionnaire collected personal information, the consciousness of the cancer early treatment and relevant factors. The Chi square test was used to compare the difference between the consciousness of the cancer early treatment and relevant factors among the four groups. The logistic regression model was used to analyze the influencing factors related to the consciousness of the cancer early treatment.@*Results@#With the assumption of being diagnosed as precancer or cancer, 89.97% of community residents, 91.84% of cancer risk assessment/screening population, 93.00% of cancer patients and 91.52% of occupational population would accept active treatments (P<0.001). If the immediate family members were diagnosed as precancer or cancer, people who would encourage their family members to receive early treatment in the four groups accounted for 91.96%, 91.94%, 92.44% and 91.55%, respectively (P<0.001). The company employees, annual household income with 40 000 yuan and more and other three groups had a relatively better consciousness of the cancer early treatment (P<0.05). Male, widowed, unemployed and from the central and western regions had a relatively worse consciousness of the cancer early treatment (P<0.05).@*Conclusion@#Residents in urban China participants had a good consciousness of the cancer early treatment. The marital status, occupation, annual household income and residential regions were major factors related to the consciousness of the cancer early treatment.
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Objective@#To understand the consciousness of the cancer early diagnosis among urban residents and identify the related factors from 2015 to 2017.@*Methods@#A cross-sectional survey was conducted in 16 provinces covered by the Cancer Screening Program in Urban China from 2015 to 2017. A total of 32 257 local residents aged ≥18 years old who could understand the investigation procedure were included in the study by using the cluster sampling method and convenient sampling method. All local residents were categorized into four groups, which contained 15 524 community residents, 8 016 cancer risk assessment/screening population, 2 289 cancer patients and 6 428 occupational population, respectively. The general demographic characteristics, the consciousness of the cancer early diagnosis (whether people would have a willingness or encourage their relatives/friends to confirm the abnormal results once which were detected from the physical examination) and other information were collected by using the self-designed questionnaire. The non-conditional logistic regression model was used to identify the relateol factors related to the consciousness of the cancer early diagnosis.@*Results@#As for residents with abnormal result from the physical examination, 89.29% (28 802) of residents would choose to seek medical treatment for further diagnosis. If their relatives/friends had abnormal results from the physical examination, 89.55% (28 886) of residents would encourage their relatives/friends to confirm the diagnosis in time. The non-conditional logistic regression model analysis showed that compared with the public institution staff/civil servants, annual household income less than 20 000 CNY, the western region and the cancer risk assessment/screening intervention population, the company staff, annual household income about 40 000 CNY and more, and the residents from the middle and eastern region had a stronger consciousness to seek further diagnosis; while the unemployed residents and community residents were less likely to seek further diagnosis (P<0.05).@*Conclusions@#From 2015 to 2017, the Chinese urban residents had a good consciousness of the cancer early diagnosis. Occupation, annual household income, residential region and population group were related to the consciousness of the cancer early diagnosis.
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Objective@#To understand the consciousness of the cancer early detection among urban residents and identify the influencing factors from 2015 to 2017.@*Methods@#A cross-sectional survey was conducted in 16 provinces covered by the Cancer Screening Program in Urban China from 2015 to 2017. A total of 32 257 local residents aged ≥18 years old who could understand the investigation procedure were included in the study by using the cluster sampling method and convenient sampling method. All local residents were categorized into four groups, which contained 15 524 community residents, 8 016 cancer risk assessment/screening population, 2 289 cancer patients and 6 428 occupational population, respectively. Self-designed questionnaires were used to collect population, socioeconomic indicators, self-cancer risk assessment, regular participation in physical examination and other information. The multivariate logistic regression model was used to identify the factors of people who had not regularly participated in the regular physical examination in the past five years.@*Results@#The self-assessment results of 32 357 residents showed that there were 27.54% (8 882) of total study population with self-reported cancer risk, 45.48% (14 671) without cancer risk and 26.98% (8 704) with unclear judgement on their own cancer risk. Among population with cancer risk, 79.84% (7 091) considered physical examination accounted. In the past five years, there were 21 105 (65.43%) residents participated in regular physical examination and 11 148 (34.56%) participated in non-scheduled one, respectively. The multivariate logistic regression analysis showed that compared with unmarried and western region residents, divorced, middle and eastern region residents had a stronger consciousness to participate in the regular physical examination (P<0.05). Compare with residents with annual household income less than 20 000 CNY in 2014, cancer risk assessment/screening intervention population, and self-assessment with cancer risk, residents with annual household income between 20 000 CNY and 59 000 CNY in 2014, occupational population, community residents, cancer patients, self-reported cancer-free risk, and self-assessment with unclear judgement of cancer risk were less likely to participate in the regular physical examination (all P values <0.05).@*Conclusion@#From 2015 to 2017, the Chinese urban residents had a acceptable consciousness of the cancer early detection. The marital status, annual household income, population group and self-assessment of cancer risk were related to the consciousness of the cancer early detection of people who had not participated in the regular physical examination in the past five years.
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Objective@#To understand the health literacy and relevant factors of cancer prevention consciousness in Chinese urban residents from 2015 to 2017.@*Methods@#A cross-sectional survey was conducted in 16 provinces covered by the Cancer Screening Program in Urban China from 2015 to 2017. A total of 32 257 local residents aged ≥18 years old who could understand the investigation procedure were included in the study by using the cluster sampling method and convenient sampling method. All local residents were categorized into four groups, which contained 15 524 community residents, 8 016 cancer risk assessment/screening population, 2 289 cancer patients and 6 428 occupational population, respectively. The self-designed questionnaire was used to collect the information of demographic characteristics and cancer prevention consciousness focusing on nine common risk factors, including smoking, alcohol, fiber food, food in hot temperature or pickled food, chewing betel nut, helicobacter pylori, moldy food, hepatitis B infection, estrogen, and exercise. The logistic regression model was adopted to identify the influencing factors.@*Results@#The overall health literacy of the cancer prevention consciousness was 77.4% (24 980 participants), with 77.4% (12 018 participants), 79.9% (6 406 participants), 77.2% (1 766 participants) and 74.5% (4 709 participants) in each group (P<0.001). The correct response rates for nine risk factors ranged from 55.2% to 93.0%. The multivariate logistic regression analysis showed that compared with community residents, people with primary school level education or below, and the number of people living together in the family <3, the cancer risk assessment/screening intervention population, cancer patients, those with junior high school level educationor above and the number of people living in the family ≥3 had better health literacy of the cancer prevention consciousness (all P values <0.05). Compared with females, 39 years old and below, government-affiliated institutions or civil servants, from the eastern region, males, older than 40 years, company or enterprise employees, and from the middle or western region had worse health literacy of the cancer prevention consciousness (all P values <0.05).@*Conclusion@#The health literacy of the cancer prevention consciousness in Chinese urban residents should be improved. The cancer screening intervention, gender, age, education, occupation, the number of people co-living in the family, and residential region were associated with the health literacy of the cancer prevention consciousness.
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Immune checkpoint inhibitors have been approved for clinical application in China. However, the increased immune-related adverse event (irAE) needs more attention. This review summarized the incidence, characteristic clinical manifestation and treatment of irAEs associated with programmed cell death protein-1(PD-1) and programmed cell death ligand-1(PD-L1) inhibitors. To have a deep insight into irAE, the potential mechanisms, the different incidences of cancer types, influencing factors and the direction of future research were also discussed here to provide guidance for clinical oncologist to identify and monitor irAE.
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BACKGROUND@#Early investigation suggested patients' level of awareness regarding clinical trials was related with willingness to participation. This study was intended to evaluate the level of awareness of cancer patients regarding clinical trials and related influencing factors, and to compare the differences of awareness between patients who attended clinical trials before and not.@*METHODS@#From Jun, 2018 to April, 2019, standardized question-naires were gathered from cancer patients (attended clinical trials vs not attended clinical trials) in our hospital regarding basic information and 10 other questions about awareness. The level of awareness was evaluated and patients were classified into "low cognition" and "high cognition" groups. Logistic regression analysis was performed to determine whether certain characteristics would predict for awareness.@*RESULTS@#Of the 617 participants, 38.6% have attended clinical trials before. 338 (54.6%) patients had a correct overall understanding of clinical trials, while 44 (7.1%) patients still thought participants were the victim of scientific research. Except for the compensation of medical expenses (51.5% vs 48.7%) and related laws of clinical trials (52.3% vs 45.5%), other parts of understanding were elevated in patients attended clinical trials before comparing with patients who didn't, including significance (86.2% vs 77.6%), risk disclosure (91.2% vs 71.6%), confidentiality (73.2% vs 59.7%), voluntariness (95.8% vs 76.3%), withdrawal (86.6% vs 68.2%) and expenses (62.8% vs 39.2%). The proportion of participants who understand these components did not increase even in 239 patients who had attended clinical trials before. Participants who attended clinical trials before (OR=1.83, 95%CI: 1.11-3.00), unmarried/divorced (OR=5.04, 95%CI: 1.73-14.66), retired (OR=2.53, 95%CI: 1.16-5.50) had a higher level of awareness, while patients who had bad impression with doctors (OR=0.43, 95%CI: 0.26-0.72) had lower awareness.@*CONCLUSIONS@#The current level of awareness for clinical trials of cancer patients in our hospital was relatively low, even in patients who had attended clinical trials before. It's necessary to improve patients' awareness of clinical trial by promoting harmony relationship between patients and doctors, as well as by enhancing related propagation. Strengthening the adequacy and efficacy of informed consent in clinical trials also needs to be achieved in the future.
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BACKGROUND@#The clinical trials of new anti-tumor drugs are prospering in China. The acceptance of clinical trials in patients is an important factor affecting the speed and quality of clinical trials. Previous studies have investigated the acceptance of clinical trials in those cancer patients, who have never participated in a trial. This study is designed to investigate and compare the acceptance and related causes of clinical trials in cancer patients who have once participated in a clinical trial or not.@*METHODS@#From June 2018 to April 2019, a standardized questionnaire-based survey was conducted among two groups of cancer patients classified by history of clinical trial participation in Cancer hospital, Chinese Academy of Medical Science, mainly focusing on their overall acceptance of clinical trials and related considerations, including the role of attending doctors, as well as group differences between the two participants.@*RESULTS@#A total of 538 patients were enrolled with an average age of 53.5 years old, 51.1% of whom were males, and 43.3% of whom have never participated in a clinical trial. Overall, 502 patients (93.3%) were willing to or recommend their relatives or friends to participate in clinical trials, and patients with history of clinical trial participation had higher willingness (96.6% vs 90.8%, P=0.008). Patients were most likely to be motivated by expectation of optimal treatment (100.0% vs 99.3%) for both those who had once participated in a clinical trial or those not, respectively followed by financial burden reduction (56.0%) and recommendation by attending doctor (43.7%). The main reasons for unwillingness-to-participate for those who had once participated in a clinical trial were abandoning other treatment options, divided into control group or additional visits, while for those who had never participated in a clinical trial, ineffective treatment or serious adverse reactions were their main concerns. In the decision-making of clinical trial participation, 88% patients highly valued the role of recommendation by attending doctors. Among patients without trial participation history, 60.9% of those had no unwillingness-to-participate expressed that recommendation by attending doctors would change their decisions. The study also reported patients' preferences for information and access to clinical trials.@*CONCLUSIONS@#The acceptance of clinical trials in cancer patients in our hospital is generally high, especially in patients who had a history of trial participation. It's of substantial significance to give full play to the role of doctors in improving the acceptance of clinical trials of cancer patients in China.
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Objective To determine the acceptance and willingness to pay for breast cancer screening among populations at high risk of breast cancer in urban China. Methods From 2012 to 2014, a cancer screening program in urban China (CanSPUC) was carried out in 13 provinces. The current survey was conducted among participants who were evaluated as having"high?risk for breast cancer"using a Harvard model (community?based) and then underwent breast mammography or ultrasonography screening procedure (hospital-based). The study mainly focused on their acceptance and willingness to pay under certain self?payment assumption for breast cancer screening. Results A total of 3 049 participants, with a mean age of 52.4±7.0 years, were included. The group aged 45 to 55 years accounted for 50% of the patients, and the median annual income per capita in the recent 5 years was 22 000 (15 000-34 000) Chinese yuan (CNY). Educational level, occupation, and marital status may affect their full acceptance and voluntary payment (P<0.05). Of all the participants, 99% (3 016 participants) could totally or substantially accept the breast cancer screening. When the breast cancer screening was assumed to be conducted every 3 years in the low?cost self?paid context, 85% (2 581 participants) of the participants had the willingness to pay, while only 17% were willing to pay >100 CNY. The remaining 15% of the residents showed no willingness to pay, and the unaffordable expenditure (70%, 438 participants) and unnecessary screening (24%, 112 participants) were the primary considerations. Significant differences in acceptance, willingness to pay, and payment were found among the provinces. Conclusion Almost all high?risk populations for breast cancer could accept breast cancer screening. The willingness to pay was relatively high, but the amount of payment was limited and low.
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Objective To estimate the mean annual expenditure of patients with prevalent liver cancer in China on the perspective of the natural progression of the disease and to provide baseline information for liver cancer?related disease burden estimation and evaluation of prevention strategies. Methods A multicenter survey on liver cancer was conducted between 2012 and 2014 in 13 sites where the cancer screening program was conducted in Urban China, by face?to?face interviews with hospitalized patients. Data on basic information, clinical diagnosis and treatment, direct medical expenditure, and direct non?medical expenditure were collected. By?year expenditure and number of visits from the first visit to the end of the survey were analyzed. The trend for the two indicators in each year was analyzed. The subgroup analysis of factors such as sex and age was conducted. All the expenditure data were discounted to the year 2014 and presented in Chinese yuan. The statistical analysis was performed using the SAS 9.4 software. Results A total of 2 222 patients with liver cancer, with a mean age of 55.7±11.2 years, were included. Men accounted for 79.2% (1 759 cases) of the patients, women accounted for 20.8% (463 cases) of the patients, and 75.6% (1 679 cases) of the cases were from cancer hospitals. Stage Ⅰ cases only accounted for 14.1% (299 cases) of all the cases, and most cases were stageⅢorⅣ(62.6%, 1 325 cases). Of the cases, 64.4% (1 430 cases) had pathological information, and 83.6%(1 195 cases) were pathologically hepatocellular carcinoma. The sample sizes for the first 3 years from the first visit were 2 222, 149, and 57, respectively (by?year sample sizes thereafter were<50). The annual total medical expenditures for the first 3 years were 49 091 yuan (95% confidence interval [CI]: 47 376-50 806), 30 506 yuan (95% CI: 26 462-34 549), and 32 100 yuan (95% CI: 25 917-38 283) (P<0.001). The corresponding number of visits were 1.9, 1.6, and 1.5 (P<0.001). The trend for each province was consistent with the overall trend, while the down trend from years 1 to 2 varied among provinces, ranging from 1.4 (Zhejiang province) to 5.6 times (Henan province). For the trend in the first 3 years, differences were found in subgroups such as region (P<0.001) and treatment (P<0.05), instead of sex, age, stage, and other subgroups. Conclusions For liver cancer patients in China, the annual expenditure for the first year in the whole disease course was 1.6 times higher than that for the second year, which varied among provinces. However, information on annual expenditure for the later course of liver cancer is still limited.
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Objective@#To acknowledge the availability and rates of annual transition of outcomes during the progression and regression stages of colorectal cancer (CRC) and related diseases, by pooling global follow-up studies on the natural history of CRC.@*Methods@#Till March, 2017, data was collected through systematic literature review over multiple databases, including PubMed, Embase, Cochrane and Chinese Biology Medicine (CBM) disc. Information regarding the characteristics, classification system of health states, related outcomes and incidence rates on CRC or high-risk adenoma for the surveillance cohorts of the studies, were extracted and summarized. Both Meta and sensitivity analyses were performed on those outcomes if they appeared in more than 3 studies, using the random effects model. Annual transition rate with 95%CI was used to estimate each of the outcomes, Quality of the studies was assessed, using the Newcastle-Ottawa Scale.@*Results@#A total of 29 cohort studies were included, with the mean follow-up period as 5.7 years. All studies except one, focused on adenoma-carcinoma pathway and reported the outcome parameters of adenomas by different risk, and some reported the findings on different sizes (n=6) of adenomas. These cohorts were divided into three groups (normal status, with low-risk or high-risk adenoma) according to the status of baseline endoscopic pathologic findings. Their available outcome parameters, corresponding number of involved articles, aggregated sample size and pooled annual transition rates were presented. Six parameters were obtained in the normal cohorts, including those from normal to low-risk adenoma (16 articles, 58 235, 0.030: 0.024-0.037), to high-risk adenoma (17 articles, 62 089, 0.003: 0.002-0.004), to diminutive adenoma (<5 mm, 4 articles, 1 277, 0.021: 0.013-0.029), to small adenoma (6-9 mm, 4 articles, 1 277, 0.006: 0.001-0.010), to large adenoma (≥10 mm, 7 articles, 3 531, 0.002: 0.000-0.003) and to CRC (19 articles, 104 836, 0.000 3: 0.000 2-0.000 5). Three parameters were obtained in low-risk adenoma in cohorts with polypectomy findings, including recurrence (9 articles, 4 788, 0.109: 0.062-0.157) from low-risk adenoma after polypectomy to high-risk adenoma (10 articles, 5 736, 0.009: 0.004-0.013) and to CRC (12 articles, 11 347, 0.000 6: 0.000 4-0.000 8). Three parameters were obtained on high-risk adenoma from cohorts with polypectomy findings, including recurrence (12 articles, 7 030, 0.038: 0.028-0.048) from high-risk adenoma after polypectomy to low-risk adenoma (8 articles, 2 489, 0.133: 0.081-0.185) and CRC (14 articles, 14 899, 0.002: 0.001-0.003). Except for normal to low-risk adenomas, results from the sensitivity analysis for the other parameters showed stable. Of the included studies, two presented incidence rates of CRC in different clinical stages and the another two were focusing on the parameters related to serrated pathway.@*Conclusions@#Globally, follow-up studies reported data on natural history of colorectal cancer is of paucity. Compared to the "adenoma-carcinoma" pathway, transition parameters of the serrated lesion pathway are more limited. This Meta-analysis provided convincing evidence for optimizing the strategies regarding follow-up program on the disease, using the baseline endoscopic findings from global CRC Screening Program. These results also offered strong data-related support for Chinese population- specific interventional model on colorectal cancer.
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Objective To gather available evidence related to the economic evaluation on breast cancer screening in mainland China and to provide reference for further research.Methods A systematic review was conducted to identify articles in PubMed and three Chinese databases (CNKI,Wanfang and VIP) during 1995-2015.Data related to descriptive characteristics,rates on participation and detection for population-based studies,methods for model-based studies,types of economic evaluation and results,were extracted.A Consolidated Health Economic Evaluation Reporting Standards (CHEERS) was used to assess the reporting quality of included studies.Results Of the 356 records searched in the databases,13 studies (all published between 2012 and 2015) were included in the current paper involving 11 population-based studies and 3 model-based evaluations (1 study using both methods).Age of the participants who started to be engaged in the screening program ranged from 18 to 45 years old,but terminated at the age of 59 years or older.The screening modalities included single-used clinical breast examination,mammography and ultrasound or combined applications.Study persepectives were described in 7 studies,with 5 from the healthcare providers,and 2 from societal angles.Only 5 studies discounted cost or effectiveness.Out of 11 papers,9 showed the results on cost-effectiveness analysis (CEA) that reporting the cost per breast cancer detection,with median as 145.0 thousand Chinese Yuan (CNY),ranging from 49.7 thousand to 2 293.0 thousand CNY.From 4 papers with results of cost-utility analysis (CUA),the cost per quality adjusted life year (QALY) gained or cost per disability adjusted life year (DALY) averted,were evaluated.The incremental cost-effectiveness ratio (ICER) was from 2.9 thousand to 270.7 thousand CNY (GDP per capita of China was CNY 49.3 thousand in 2015).In 13 studies,the quality of reporting varied,with an average score of 14.5 (range:9.5-21.0).In the domains of study perspective,discounting,ICER and uncertainty,all the scores of equalities were relatively levels.Conclusions Currently,evidence on economic evaluation of breast cancer screening in mainland China remained limited and weakly comparable,particularly model-based studies.Comprehensive analysis from societal perspective and QALY or DALY related cost-utility analysis should be implemented.
ABSTRACT
Objective To gather available evidence related to the economic evaluation on breast cancer screening in mainland China and to provide reference for further research.Methods A systematic review was conducted to identify articles in PubMed and three Chinese databases (CNKI,Wanfang and VIP) during 1995-2015.Data related to descriptive characteristics,rates on participation and detection for population-based studies,methods for model-based studies,types of economic evaluation and results,were extracted.A Consolidated Health Economic Evaluation Reporting Standards (CHEERS) was used to assess the reporting quality of included studies.Results Of the 356 records searched in the databases,13 studies (all published between 2012 and 2015) were included in the current paper involving 11 population-based studies and 3 model-based evaluations (1 study using both methods).Age of the participants who started to be engaged in the screening program ranged from 18 to 45 years old,but terminated at the age of 59 years or older.The screening modalities included single-used clinical breast examination,mammography and ultrasound or combined applications.Study persepectives were described in 7 studies,with 5 from the healthcare providers,and 2 from societal angles.Only 5 studies discounted cost or effectiveness.Out of 11 papers,9 showed the results on cost-effectiveness analysis (CEA) that reporting the cost per breast cancer detection,with median as 145.0 thousand Chinese Yuan (CNY),ranging from 49.7 thousand to 2 293.0 thousand CNY.From 4 papers with results of cost-utility analysis (CUA),the cost per quality adjusted life year (QALY) gained or cost per disability adjusted life year (DALY) averted,were evaluated.The incremental cost-effectiveness ratio (ICER) was from 2.9 thousand to 270.7 thousand CNY (GDP per capita of China was CNY 49.3 thousand in 2015).In 13 studies,the quality of reporting varied,with an average score of 14.5 (range:9.5-21.0).In the domains of study perspective,discounting,ICER and uncertainty,all the scores of equalities were relatively levels.Conclusions Currently,evidence on economic evaluation of breast cancer screening in mainland China remained limited and weakly comparable,particularly model-based studies.Comprehensive analysis from societal perspective and QALY or DALY related cost-utility analysis should be implemented.