Abstract
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.
Challenges of globalization of cancer drug trials- recruitment in LMICs, approval in HICs
