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.
ObjectiveTo compare the current status of clinical studies regarding lung cancer between China and the United States in 2019, and to indicate the weakness, trend and future development direction of clinical studies drug treatment in China.MethodsThe data of lung cancer clinical studies from January 1st to November 30th, 2019 in China and the United States were retrieved and analyzed through Informa pharmaprojects database.ResultsThe United States was superior on the number of projects (128 vs. 156) and research institutions (743 vs. 2 250). Compared with the United State, there were more phase Ⅲ confirmatory researches (19.5% vs. 10.3%), bioequivalent drug researches (3.1% vs. 0%), and researches initiated by academic institutions (39.8% vs. 28.1%) in China. The United States exhibited advantages in phaseⅠ andⅠ/Ⅱstudies (25.8% vs. 60.3%), immunodrugs (49.2% vs. 60.3%), primary tested drug ratio (61.7% vs. 93.6%), targets abundance (32.9% vs. 69.6%), and chimeric antigen receptor-T (CAR-T, 0.7% vs. 7.1%).ConclusionCompared with the United States, China should pay more attention to innovative drug investigations in early phase of clinical studies, especially novel immune agents, vaccines, and CAR-T.
Objective To systematically review the health utility scores for patients with breast cancer in China. Methods PubMed, EMbase, The Cochrane Library, Web of Science, CNKI, WanFang Data, CBM and VIP databases were searched from inception to November, 2016 to collect studies for health utility scores for breast cancer in China. Two reviewers independently screened literature, extracted data, and assessed the risk of bias of included studies. Meta-analysis was performed using Stata 12.0 software. Results A total of 6 studies were included. Compared with modeling studies, the range of utility scores from cross-sectional studies was narrower. The results of meta-analysis showed the utility scores for breast cancer were 0.77 (95%CI 0.67 to 0.87), 0.77 (95%CI 0.68 to 0.86) at stage 0 to Ⅰ, 0.76 (95%CI 0.66 to 0.85) at stage Ⅱ, 0.74 (95%CI 0.65 to 0.83) at stage Ⅲ and 0.73 (95%CI 0.65 to 0.81) at stage Ⅳ, respectively. Meanwhile, we descripted the median of utility scores of all studies, and the corresponding values were 0.81 (range 0.65 to 0.83), 0.82 (range 0.65 to 1.00) at stage 0, 0.82 (range 0.65 to 0.90) at stage Ⅰ, 0.77 (range 0.67 to 0.86) at stage Ⅱ, 0.70 (range 0.64 to 0.82) at stage Ⅲ and 0.70 (range 0.30 to 0.80) at stage Ⅳ, respectively. Conclusion Research on the health utility scores of breast cancer is still limited in China. Utility scores are decreasing among different clinical stages, with lowest score at late stage cancer. These findings can be used in further cost-utility evaluation on various breast cancer interventions.
ObjectivesTo analyze the average daily medical expenditures for primary liver cancer in China from 2002 to 2011.MethodsThis study employed retrospective survey on multiple centers from 12 provinces and cities in China from 2002 to 2011, based on the continuous data from the Cancer Screening Program in the Urban China Project. The average daily medical expenditures of primary liver cancer patients and influencing factors were analyzed.ResultsA total of 11 045 liver cancer patients from 12 provinces and cities were included, with an average age of 55 and an average duration of hospitalization of 16.76 days. The average daily medical expenditures of liver cancer patients during the 10 years was 1 251 yuan (95%CI 1 236 to 1 266). The average daily medical expenditures was significantly different in regions (1 356 yuan in the east region, 1 209 yuan in the middle region and 1 068 yuan in the west region), types of hospital (1 341 yuan in general hospitals, 1 213 yuan in specialized hospitals) and hospital levels (1 293 yuan in 3A grade hospital, 805 yuan in non-3A grade hospital) (P<0.05). The average daily medical expenditures were 1 253 yuan for stage Ⅰ, 1 169 yuan for stage Ⅱ, 1 167 yuan for stageⅢ and 1 092 yuan for stage Ⅳ (P<0.05). From 2002 to 2011, the average daily medical expenditures of hospitalization increased from 1 079 yuan (95%CI 1 021 to 1 136) to 1 549 yuan (95%CI 1 486 to 1 613), with an average growth rate of 3.69%. Since 2007, a continuous growth was observed. Subgroup analysis suggested there were obvious differences in growth patterns between different regions and hospitals, as well as differences between various treatments.ConclusionsThe average daily medical expenditures of liver cancer in China had been increasing from 2002 to 2011 and there were significant differences between various regions and hospital levels. Combined with data on the change of duration of hospitalization, it can provide reference for the economic evaluation of the nation’s prevention and treatment policies for liver cancer.
ObjectivesTo systematically review the health utility scores and disability weights of liver cancer and related diseases in China.MethodsPubMed, EMbase, The Cochrane Library, Web of Science, CNKI, WanFang Data, CBM and VIP databases were electronically searched to collect the studies of health utility scores and disability weights of liver cancer and related diseases in China from inception to November, 2017. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies, then, meta-analysis was performed by using Stata 12.0 software.ResultsA total of 9 studies were included which covered 10 related diseases, among which chronic hepatitis B, compensated cirrhosis, decompensated cirrhosis and liver cancer were the mostly reported. The overall quality was adequate, and EQ-5D was the most common tool in these studies. Results of meta-analysis showed that healthy utility scores of the four common diseases were 0.789 (0.735, 0.843), 0.734 (0.693, 0.776), 0.647 (0.627, 0.666) and 0.636 (0.508, 0.765), respectively. Measures from EQ-5D were 0.825 (0.762, 0.868), 0.761 (0.731, 0.791), 0.643 (0.620, 0.666) and 0.620 (0.473, 0.766), respectively. In addition, the corresponding median (range) utility scores of the four diseases were found to be 0.758 (0.520–0.950), 0.716 (0.570–0.900), 0.538 (0.260–0.662) and 0.541(0.310–0.720). Only one disability weight study was concluded (0.360–0.900 reported for liver cancer).ConclusionIn Chinese population, current evidences on health utility of liver cancer and related diseases are limited, particularly data on disability weights. Utility values from meta-analysis seems more optimistic and centralized than those from descriptive analysis. Different survey tools yield varying outcomes, and attentions should be addressed to their application. The decrease of heath utility scores with the severity of liver disease suggests that early prevention, early diagnosis and treatment can save more years of life with enhanced quality.
ObjectiveTo systematically review the status of economic evaluation of liver cancer screening in China, so as to provide reference for further studies.MethodsPubMed, EMbase, The Cochrane Library, Web of Science, CNKI, WanFang Data, CBM and VIP databases were searched to collect economic evaluation studies of liver cancer screening in China from inception to December, 2017. Two reviewers independently screened literature, extracted data and conducted descriptive analysis of basic characteristics, methods of economic evaluation and main results as well as quality and uniformity of reporting.ResultsA total of 5 studies were included. Among them, the starting age of screening were found to be 35 to 45 years old; α-fetoprotein (AFP) testing and ultrasound examination combined procedure and screening interval of every 6 months were mostly evaluated. The quality of the 5 studies was satisfactory, and the uniformity of reporting was relatively acceptable, with a median score of 78% (range: 60% ~ 78%). Two population-based studies reported cost per liver cancer detected (44 thousand and 575 thousand yuan). Three studies reported cost-effectiveness ratio(CER) based on life year saved (LYS) and quality adjusted life year (QALY). Among these results, only 1 study from mainland China reported CER based on LYS (1 775 yuan), and the calculated ratio of CER to local GDP per capita was estimated as 0.1, while 2 studies from Taiwan province reported 4 CERs, and the ratios of CER to local GDP per capita ranged from 1.0 to 2.2.ConclusionsInformation from liver cancer endemic areas such as Taiwan province indicates promising cost-effectiveness to conduct liver cancer screening in local general population, while data from mainland suggests that conducting liver cancer screening combining AFP and ultrasound in high-risk population will be cost-effective, however only supported by 1 regional study. This needs to be verified by further economic evaluations based on randomized controlled trials or cohort studies as well as health economic evaluations.
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.