RESUMO
Objective:This study is to understand the hot spots and trends in the recruitment of clinical trial subjects in China over the past 20 years, explore the existing problems and countermeasures, and provide scientific ideas for domestic clinical trial institutions to effectively solve the problem of subject recruitment.Methods:Bibliometric analysis was used to study the relevant literature from three major domestic databases from 2001 to 2021, analyzing key indicators such as annual publication volume, journal distribution, institutional distribution, regional distribution, and high-frequency keyword co-occurrence.Results:A total of 162 articles were selected. The results showed that the overall publication volume in this field showed an upward trend, and the research institutions were diversified, with a concentration of medical and pharmaceutical institutions and universities. The current research hotspots in this field focused on quality and efficiency improvement of subject recruitment, with themes of subject protection, ethical review, regulation development, standardized management, etc.Conclusions:The research in this field has made significant progress, but the overall research level is still relatively weak. Therefore, it is suggested that the country should play a role in macro-regulation, on the one hand, starting with top-level design, promoting the construction of a standardized management system for subject recruitment, continuously strengthening subject protection, and enhancing the effectiveness of scientific recruitment. On the other hand, releasing the potential of grassroots institutions and giving full play to the volume advantage by promoting the sinking of advantageous resources. Meanwhile, great importance should be attached to the development of Phase I clinical trials, giving full play to the strong internal energy of traditional medicine and promoting the development of Chinese traditional medicine. These multi-measures should provide a theoretical basis for exploring the transformation of ′clinical research hospitals′, and promote the high-quality development of new drug research and development in China.
RESUMO
Strengthening clinical research is an inevitable requirement for expediting the development of the medical and healthcare services, as well as enhancing the capability of the hospitals in China. On the basis of sufficient argumentation of the significance and the internal and external environment of developing clinical research according to structure-conduct-performance analysis model, Henan Cancer Hospital set the aim of transforming from clinical hospital to clinical research hospital. By constructing a high-level phase Ⅰ clinical trials center, establishing the department of clinical research management, promoting the collaborative innovation and cooperation among medical institutions, research institutions, and enterprises, and developing the accessory clinical trial management system, Henan Cancer Hospital has turned abundant patient resources into advantages of clinical research. The quality and quantity of clinical trials have been elevated significantly, which could provide strong impetus for hospital′s discipline construction and high-quality development.