China to roll back regulations for traditional medicine despite safety concerns

Cyranoski, David

doi:10.1038/nature.2017.23038

Cited by 15 publications

(7 citation statements)

References 3 publications

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“…Chinese medicine was postponed [17] . Even, it's suggested that traditional Chinese medicine that meet relevant requirements can be exempted from application for efficacy study and clinical trial study [18] .…”

Section: Resultsmentioning

confidence: 99%

Temporal trends and geographic differences of insurance coverage for cancer drug trials in mainland China

Huang

Fan

et al. 2019

Preprint

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Background: To analyze the time trend and regional difference of insurance coverage of cancer drug trials in mainland China for the past decade, thus to provide data support for the improvement and implementation of related policies, such as clinical trial insurance and ethical review in China. Methods: Based on the national authoritative database, “Drug Clinical Trial Registration and Information Disclosure Platform”, the time trend analysis of insurance coverage of cancer drug trials was conducted, from both the perspectives of trials and participants. Meanwhile, the group comparisons between seven regions, as well as different drug types and study phases, were also performed. Data processing and analysis were carried out using SAS 9.4. Mann-Kendall test was used for trend analysis, and chi-square test was used to conduct group comparisons. Results: A total of 1433 clinical trials were finally included, with 1153 (80.5%) trials being international. In average, the insurance rate of trials was 75.9%, and it was steadily increased by 7.8% annually. While the insurance coverage of Chinese participants was 58.8%, and it showed a wavy upward trend. Compared with international trials (90.0%), insurance rate of domestic trials (72.4%)) was significantly lower ( P < 0.001), but the rate gap decreased gradually. The comparisons by region showed that, the insurance rate for clinical trials in Northeast China (83.3%) was the highest, followed by South area (80.7%), North area (78.1%), and that for Northwest China (37.5%) was lowest. Compared with chemicals (74.8%) and biological products (79.9%), trials on traditional Chinese medicine had significantly lower rate of insurance (30.4%). For different study phase, insurance coverage in BE studies was the lowest (57.1%), followed by phase II trials, while it achieved the highest in phase III trials (85.1%). Conclusions: The insurance coverage of cancer drug trials in mainland China has been increasing steadily over the past decade. However, the regional differences are significant. To promote insurance coverage emphatically in underdeveloped areas could be our work emphasis in the near future. Although this study specially included cancer drug trials, the results could also provide reference for trials in all other fields.

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Section: Resultsmentioning

confidence: 99%

Temporal trends and geographic differences of insurance coverage for cancer drug trials in mainland China

Huang

Fan

et al. 2019

Preprint

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“…However, a weak curative effect was achieved [ 86 ]. Moreover, in the process of rapid tumor progression, the antitumor immune response mediated by immunotherapy only is insufficient to prevent the highly proliferative tumor cells, which generates unsatisfactory treatment results [ 87 ]. Concerning this aspect, chemotherapeutic agents can develop a positive function, which acts as a preferred option in tumor disease therapies [ 88 ].…”

Section: Discussionmentioning

confidence: 99%

The construction of a lymphoma cell-based, DC-targeted vaccine, and its application in lymphoma prevention and cure

Zhou

Peng

Hao

et al. 2021

Bioactive Materials

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In recent years, Non-Hodgkin lymphoma (NHL) has been one of the most fast-growing malignant tumor diseases. NHL poses severe damages to physical health and a heavy burden to patients. Traditional therapies (chemotherapy or radiotherapy) bring some benefit to patients, but have severe adverse effects and do not prevent relapse. The relevance of emerging immunotherapy options (immune-checkpoint blockers or adoptive cellular methods) for NHL remains uncertain, and more intensive evaluations are needed. In this work, inspired by the idea of vaccination to promote an immune response to destroy tumors, we used a biomaterial-based strategy to improve a tumor cell-based vaccine and constructed a novel vaccine named Man-EG7/CH@CpG with antitumor properties. In this vaccine, natural tumor cells are used as a vector to load CpG-ODN, and following lethal irradiation, the formulations were decorated with mannose. The study of the characterization of the double-improved vaccine evidenced the enhanced ability of DCs targeting and improved immunocompetence, which displayed an antitumor function. In the lymphoma prevention model, the Man-EG7/CH@CpG vaccine restrained tumor formation with high efficiency. Furthermore, unlike the non-improved vaccine, the double-improved vaccine elicited an enhanced antitumor effect in the lymphoma treatment model. Next, to improve the moderate therapeutic effect of the mono-treatment method, we incorporated a chemotherapeutic drug (doxorubicin, DOX) into the process of vaccination and devised a combination regimen. Fortunately, a tumor inhibition rate of ~85% was achieved via the combination therapy, which could not be achieved by mono-chemotherapy or mono-immunotherapy. In summary, the strategy presented here may provide a novel direction in the establishment of a tumor vaccine and is the basis for a prioritization scheme of immuno-chemotherapy in enhancing the therapeutic effect on NHL.

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“…of related trial stakeholders could be therefore weaker. In addition, from the perspective of governmental regulation, in order to promote the development of traditional Chinese medicine, the supervision of clinical trials on traditional Chinese medicine was postponed [17]. Even, it's suggested that traditional Chinese medicine that meet relevant requirements can be exempted from application for efficacy study and clinical trial study [18].…”

Section: Discussionmentioning

confidence: 99%

Temporal trends and geographic differences of insurance coverage for cancer drug trials in mainland China

Huang¹,

Tang²,

Li³

2020

Asia-Pac J Oncol

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Background Data on insurance coverage of cancer drug trials in mainland China was of paucity, especially for its time trend and regional difference. Methods Based on the national authoritative database, time trend analysis of insurance coverage of cancer drug trials was conducted, from both the perspectives of trials and participants. Meanwhile, group comparisons by region, drug type and study phase, were also performed. Mann-Kendall test was used for trend analysis, and chi-square test was used to conduct group comparisons. Results A total of 1889 clinical trials were included, with 333 being international trials. In average, the insurance rate of trials was 79.8%, and it was steadily increased by 6.8% annually from 2010 to 2019. While the insurance coverage of Chinese participants was 67.6%, and it showed a wavy upward trend. Compared with international trials (91.9%), insurance rate of domestic trials (77.2%) was significantly lower (P < 0.001), but the rate gap decreased gradually. The comparisons by region showed that, the insurance rate in Northeast China (86.6%) was the highest, while that for Northwest China (40.0%) was lowest. Additionally, traditional Chinese medicine trials, and BE studies had significantly lower rate of insurance. Conclusion The insurance coverage of cancer drug trials in mainland China has been increasing steadily over the past decade. However, the regional differences are significant. To promote insurance coverage emphatically in underdeveloped areas could be our work emphasis. Although this study specially included cancer drug trials, the results could also provide reference for trials in all other fields.

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China to roll back regulations for traditional medicine despite safety concerns

Cited by 15 publications

References 3 publications

Temporal trends and geographic differences of insurance coverage for cancer drug trials in mainland China

Temporal trends and geographic differences of insurance coverage for cancer drug trials in mainland China

The construction of a lymphoma cell-based, DC-targeted vaccine, and its application in lymphoma prevention and cure

Temporal trends and geographic differences of insurance coverage for cancer drug trials in mainland China

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