BackgroundInternational health policies and researchers have emphasized the value of evaluating patient-reported outcomes (PROs) in clinical studies. However, the characteristics of PROs in adult tumor clinical trials in China remain insufficiently elucidated. ObjectiveThis study aims to assess the application and characteristics of PRO instruments as primary or secondary outcomes in adult randomized clinical trials related to tumors in China. MethodsThis cross-sectional study identified tumor-focused randomized clinical trials conducted in China between January 1, 2010, and June 30, 2022. The ClinicalTrials.gov database and the Chinese Clinical Trial Registry were selected as the databases. Trials were classified into four groups based on the use of PRO instruments: (1) trials listing PRO instruments as primary outcomes, (2) trials listing PRO instruments as secondary outcomes, (3) trials listing PRO instruments as coprimary outcomes, and (4) trials without any mention of PRO instruments. Pertinent data, including study phase, settings, geographic regions, centers, participant demographics (age and sex), funding sources, intervention types, target diseases, and the names of PRO instruments, were extracted from these trials. The target diseases involved in the trials were grouped according to the American Joint Committee on Cancer Staging Manual, 8th Edition. ResultsAmong the 6445 trials examined, 2390 (37.08%) incorporated PRO instruments as part of their outcomes. Within this subset, 26.82% (641/2390) listed PRO instruments as primary outcomes, 52.72% (1260/2390) as secondary outcomes, and 20.46% (489/2390) as coprimary outcomes. Among the 2,155,306 participants included in these trials, PRO instruments were used to collect data from 613,648 (28.47%) patients as primary or secondary outcomes and from 74,287 (3.45%) patients as coprimary outcomes. The most common conditions explicitly using specified PRO instruments included thorax tumors (217/1280, 16.95%), breast tumors (176/1280, 13.75%), and lower gastrointestinal tract tumors (173/1280, 13.52%). Frequently used PRO instruments included the European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire–30, the visual analog scale, the numeric rating scale, the Traditional Chinese Medicine Symptom Scale, and the Pittsburgh Sleep Quality Index. ConclusionsOver recent years, the incorporation of PROs has demonstrated an upward trajectory in adult randomized clinical trials on tumors in China. Nonetheless, the infrequent measurement of the patient’s voice remains noteworthy. Disease-specific PRO instruments should be more effectively incorporated into various tumor disease categories in clinical trials, and there is room for improvement in the inclusion of PRO instruments as clinical trial end points.

Polycystic ovary syndrome (PCOS), a prevalent reproductive disorder in women of reproductive age, features androgen excess, ovulatory dysfunction, and polycystic ovaries. Despite its high prevalence, specific pharmacologic intervention for PCOS is challenging. In this study, we identified artemisinins as anti-PCOS agents. Our finding demonstrated the efficacy of artemisinin derivatives in alleviating PCOS symptoms in both rodent models and human patients, curbing hyperandrogenemia through suppression of ovarian androgen synthesis. Artemisinins promoted cytochrome P450 family 11 subfamily A member 1 (CYP11A1) protein degradation to block androgen overproduction. Mechanistically, artemisinins directly targeted lon peptidase 1 (LONP1), enhanced LONP1-CYP11A1 interaction, and facilitated LONP1-catalyzed CYP11A1 degradation. Overexpression of LONP1 replicated the androgen-lowering effect of artemisinins. Our data suggest that artemisinin application is a promising approach for treating PCOS and highlight the crucial role of the LONP1-CYP11A1 interaction in controlling hyperandrogenism and PCOS occurrence.

ObjectiveThis study aimed to evaluate the impact of the National Centralized Drug Procurement (NCDP) policy on chemical pharmaceutical enterprises’ R&D investment and provide references for improving NCDP policy design and encouraging innovation in the pharmaceutical industry.MethodsUsing the panel data of 102 Shanghai and Shenzhen A-share listed enterprises from 2016 to 2022 under the chemical pharmaceutical classification of Shenwan in Wind database as the research sample, this study developed difference-in-differences (DID) models on bid-winning and bid-non-winning enterprises, respectively, to evaluate the impact of NCDP policy on their R&D investment. In addition, this study tested the heterogeneity of bid-winning enterprises based on the bid success rate, the decline of drug price, and enterprise size.ResultsThe NCDP policy could encourage chemical pharmaceutical companies to increase R&D investment, but the low bid success rate and excessive drug price reduction would reduce their R&D enthusiasm, especially for small- and medium-sized enterprises.DiscussionIt is suggested that the NCDP policy should be further improved: first, revise the bidding rule of the NCDP policy and increase the bid success rate so that more enterprises can win bids, and second, to solve the problem of excessive drug price reduction, evaluate the rationality of bid-winning prices, and introduce a two-way selection mechanism between medical institutions and supply enterprises. Integrate pharmacoeconomic evaluation into the NCDP rules to form a benign competition among enterprises. Third, attention should be paid to supporting policies for small- and medium-sized enterprises. By increasing procurement volume, shortening payment time limits, and increasing the proportion of advance payments, enterprises’ cash flow shortages can be alleviated, thus achieving fairness and inclusiveness in the implementation of the NCDP policy.

Objectives This study investigates the relationship between the prices of fixed-dose combinations (FDCs) and free-equivalent combinations (FECs) within China's National Reimbursement Drug List (NRDL). The focus is on comparing their price ratios.Methods We identified FDCs and FECs listed in the NRDL, along with recent bidding data. Publicly listed prices and characteristics of these medications were collected from Chinese government websites and commercial databases. Price ratios were calculated after adjusting for the active pharmaceutical ingredient's strength and dosage form, following the "Chinese Pharmaceutical Differential Pricing Rules."Results The analysis showed that the price ratios of FDCs to FECs in the NRDL averaged 1.11 ± 0.77 (Mean ± Standard Deviation). The price ratios varied significantly across different therapeutic areas, with the highest ratios observed in cardiovascular system drugs, followed by systemic anti-infective agents, digestive tract and metabolism drugs, and respiratory system drugs. FDCs in the negotiation catalog had lower and more stable price ratios compared to those in the regular catalog. The significant price reduction of FECs or FDCs due to the volume-based procurement (VBP) program also affected their price ratios.Conclusions The relationship between the prices of FDCs and FECs within China's NRDL is not clearly defined. These price ratios vary substantially across different therapeutic areas and drug categories and are influenced by the VBP program. These findings provide valuable insights for decision-makers on pricing strategies for newly reimbursed FDCs.

ObjectivesThis study aimed to investigate the availability, price, and affordability of nationally negotiated innovative anticancer medicines in China.DesignRetrospective observational study based on data from a nationwide medical database.Data sources/settingQuarterly data about the use of innovative anticancer medicines from 2020 to 2022 were collected from the Chinese Medicine Economic Information Network. This study covered 895 public general hospitals in 30 provincial administrative regions in China. Of the total hospitals, 299 (33.41%) were secondary and 596 (66.59%) were tertiary.Main outcome measuresThe adjusted WHO and Health Action International methodology was used to calculate the availability and affordability of 33 nationally negotiated innovative anticancer medicines in the investigated hospitals. Price is expressed as the defined daily dose cost.ResultsOn average, the total availability of 33 innovative anticancer medicines increased annually from 2020 to 2022. The median availability of all investigated medicines in tertiary hospitals from 2020 to 2022 was 24.04%, 33.60% and 37.61%, respectively, while the indicators in secondary hospitals were 4.90%, 12.54% and 16.48%, respectively. The adjusted prices of the medicines newly put in Medicare (in March 2021) decreased noticeably, with the decline rate ranging from 39.98% to 82.45% in 2021 compared with those in 2020. Most generic brands were priced much lower than the originator brands. The affordability of anticancer medicines has improved year by year from 2020 to 2022. In comparison, rural residents had lower affordability than urban residents.ConclusionsThe overall accessibility of 33 nationally negotiated innovative anticancer medicines improved from 2020 to 2022. However, the overall availability of most anticancer medicines in China remained at a low level (less than 50%). Further efforts should be made to sufficiently and equally benefit patients with cancer.

PURPOSE:Under the background of the regular implementation of the National Centralized Drug Procurement (NCDP) policy, this study aimed to assess the impacts of the NCDP policy on drug utilization of county-level medical institutions, and probe into the influencing factors of the changes in drug utilization.METHOD:A pre-post study was applied using inpatient data from a county-level medical institution in Nanjing. Drug utilization behavior of medical institutions of 88 most commonly used policy-related drugs (by generic name, including bid-winning and bid-non-winning brands) was analyzed, and the substitution of bid-winning brands for brand-name drugs after policy intervention was evaluated.RESULTS:After policy intervention, 43.18% of policy-related drugs realized the substitution of bid-winning brands for bid-non-winning brands (6.82% of complete substitution, 36.36% of partial substitution). Meanwhile, 40.90% of policy-related drugs failed to realize brand substitution. Multiple factors affected brand substitution, including: (1) Policy effect: brand substitution was more obvious after the intervention of the first and third round of NCDP. (2) Drug market competition: the greater the price reduction of bid-non-winning brands, the more the drugs for the same indication, the more likely that medical institutions keep using the same brands as they did before policy intervention. (3) Previous drug utilization of medical institutions: brand substitution was more obvious in drugs with large number of prescriptions and weak preference for brand-name drugs.CONCLUSION:The NCDP policy promoted the substitution of bid-winning brands for bid-non-winning brands. However, the NCDP policy remained to be further implemented in county-level medical institutions. Policy implememtation efforts, drug market competition and drug utilization of medical institutions would affect the implementation of the NCDP policy.

ObjectiveThis paper examines the impact of healthcare industry convergence on the performance of the public health system in the eastern, central, and western regions of China.MethodsPublic health performance was measured by a composite index of three standards: average life expectancy at birth, perinatal mortality, and maternal mortality. The healthcare industry convergence was measured using a coupling coordination degree method. The spatial lag, spatial error, and spatial Durbin models were used to estimate the effect of healthcare industry convergence on public health system performance and this effect’s spatial dependence and heterogeneity across eastern, central, and western China using panel data from 30 Chinese provinces from 2002 to 2019.ResultsThe convergence of the healthcare industry significantly promotes regional public health [β =0.576, 95% CI: (0.331,0.821)]. However, the convergence does not have a spatial spillover effect on the public health system at the national level. Additionally, analysis of regional heterogeneity shows that the direct effects of healthcare industry convergence on public health are positive and statistically significant for Eastern China, statistically insignificant for Central China, and positive and statistically significant for Western China. The indirect effects are negative, statistically significant, positive, statistically significant, and statistically insignificant for these three regions, respectively.ConclusionPolicy efforts should strengthen the convergence between the healthcare industry and relevant industries. It can produce more current healthcare services to improve public health and reduce regional health inequality.

Objectives: This study evaluates the cost-effectiveness of adding prolonged-release (PR)-fampridine to best supportive care (BSC) versus BSC alone in adult multiple sclerosis patients with walking disability in China. Materials & methods: A hybrid decision tree and Markov model from both the societal and healthcare perspectives were constructed. Parameters were derived from clinical trials of PR-fampridine, published sources and clinical expert interviews. Results: Over a 10-year time horizon, adding PR-fampridine to BSC led to 0.15 quality-adjusted life year (QALY) gain and lower costs, with incremental cost-effectiveness ratios of -238,806 Chinese Yuan/QALY and -113,488 Chinese Yuan/QALY from the societal and healthcare perspectives, respectively. Conclusion: Compared with BSC alone, PR-fampridine plus BSC is considered an economically dominant strategy for the treatment of multiple sclerosis-related walking disability in China.

Objective This study aimed to assess whether different clinical trial endpoints in pivotal trials of cancer drugs were associated with reimbursement decisions in China. Materials and methods Cancer drugs marketed before June 30 th , 2021 with publicly available technical review reports for application of drug registration on Center for Drug Evaluation (CDE) website were reviewed. The trial design characteristics and relevant clinical outcomes [e.g., overall survival (OS), progression-free survival (PFS) and objective response rate (ORR)] were extracted from the technical review reports, while the reimbursement decisions were reviewed from National Healthcare Security Administration (NHSA) website. The differences in trial characteristics and clinical outcomes between drugs with positive reimbursement decisions and negative ones were compared by hypothesis test (Pearson's chi-squared test, Fisher's exact test, independent samples t -test and Mann-Whitney U test). The correlation between different clinical trial endpoints and reimbursement decisions was analyzed by multivariate logistic regression. Results There were 112 cancer drug indications included in this study. Among these indications, 76 received a positive reimbursement decision, and the most common primary endpoints of them were PFS (42.1%) and ORR (30.3%). Taking PFS (OR = 7.333) and ORR (OR = 5.271) as the primary endpoints were more likely to receive a positive reimbursement decision compared with OS ( P = 0.003). The proportion of drugs marketed with phase I (75.0%) and phase II (85.7%) clinical trials receiving positive reimbursement decisions are significantly higher than those marketed with phase III clinical trials (61.3%, P = 0.043). The magnitude of clinical benefit only had subtle influences (P risk benefit − OS = 0.627, P risk benefit − PFS = 0.087, P survival benefit − OS = 0.545, P survival benefit − PFS = 0.189) on the drug reimbursement decisions, however, the drug prices and clinical needs also made a difference on that. Conclusion This study found that, in Chinese drug price negotiations from 2017 to 2021, policymakers have focused more on meeting clinical needs and filling therapeutical gaps in National Reimbursement Drug List (NRDL), while requirements for the selection of primary endpoints, clinical trial phases, and clinical benefits have been reduced. In the future, emphasis should be put on the use of surrogate endpoints and clinical benefits.

Background: This paper aims to assess the impact of antibiotic therapy management by clinical pharmacists on rational drug use (RDU) in the perioperative period of patients receiving retinal detachment surgery in China from the perspective of prescription structure. Methods: In this study, a retrospective study was used to compare the differences in the RDU between 233 patients (the experimental group) receiving medical treatment and 210 patients (the control group) without clinical pharmacist intervention. The data were collected with a set of indicators adjusted from the core medication use indicator proposed by the World Health Organization and the International Network of Rational Use of Drugs according to the background of China. Results: There were significant differences in average number of drugs per prescription (19.7 and 20.8, P = 0.001), percentage of drugs on the reimbursable list (98.32% and 72.4%, P = 0.003), and average treatment expenditure per prescription (555.3 yuan and 707 yuan) between the experimental group and the controlled group, while average number of antibiotics per prescription (4.2 and 4.3, P = 0.114), average number of injections per prescription (12.02 to 11.96, P = 0.804) were not changed significantly. Conclusions: More efforts are needed to improve the effectiveness of the antibiotic therapy management by clinical pharmacist on rational drug use, meanwhile the objective of cost-saving should be included in the service pattern of clinical pharmacy services.

Local universities occupy an important position in Chinese higher education system, have made important contributions to the reform and opening up and Chinese economic development and have played an important role in promoting the popularization of higher education. There are many unfavorable factors in the development of local colleges and universities. Facing the new situation of Chinese economic transformation and upgrading of the structure of Chinese local colleges and universities faces great opportunities and challenges, this research through the methods of literature review, a detailed combing the Chinese higher education and the development of local higher education, the development present situation and existing problems, try to look for the answer to the existing problems in the development of local colleges and universities, seeking direction for the development of local colleges and universities in the future. Through this research, we believe that Chinese local colleges and universities face major opportunities and challenges in the transformation and upgrading of the national economy. China has a large population and needs a large number of high-level local colleges and universities to provide educational opportunities for them. At present, the faculty, discipline construction, teaching and research of local colleges and universities are not consistent with the current status of China's social and economic transformation and development.In the future, China's economic development requires a large number of high-level applied technical talents. Local colleges and universities should seize opportunities and achieve transformation. They should make adjustments in accordance with social development in terms of development direction selection, internal management, and discipline development. In the future, local colleges and universities in China should pay attention to the research and development, education, promotion and application of application technology for service production and life. They should emphasis on teachers' ability to translate theory into applied technology and use it in production practicing and continuously improve teachers' professional skills and comprehensive quality.