RESUMEN
With the rapid development of clinical trials, the relevant medical research and molecular detection based on biological samples are closely related to the progress of clinical trials, making the role of biological samples in clinical trials increasingly obvious. The standardized supervision mode of biological samples is an important prerequisite for carrying out high-quality clinical trials. Although the laws and regulations related to clinical trials are becoming more and more perfect, there are still a large number of adverse events related to biological samples, which seriously affects the progress and results of clinical trials, and is one of the important challenges currently facing. Therefore, it is urgent to enhance the supervision of biological samples and improve the management methods of biological samples in clinical trials at this stage. Through in-depth discussion of the current status of biological sample management in clinical trials at home and abroad, this paper analyzed the issues existed during the supervision of biological samples, and supplemented the biological sample management methods by further combing the existing relevant laws and regulations and the Guidelines for the Ethical Management of Biological Samples in Clinical Trials, with a view to providing suggestions and ideas for optimizing the management mode of biological samples in clinical trials.
RESUMEN
There are a large number of individuals with HBV infection in China, which seriously endangers public health safety. As a first-line drug used in clinical practice, tenofovir alafenamide fumarate (TAF) has the characteristics of strong efficacy, low drug resistance, and bone and kidney safety. This article summarizes the role of TAF in patients with special types of chronic hepatitis B, such as low-level viremia, multidrug resistance, pregnancy, liver failure, and liver transplantation, and the analysis shows that TAF can reduce viral load in patients with low-level viremia to achieve virologic response, provide new regimens for patients with drug resistance, block mother-to-child transmission, reduce the mortality rate of patients with end-stage liver disease, and improve renal function in patients with chronic kidney disease.
RESUMEN
Objective To summarize the experience and the insufficiency of Nanjing Drum Tower Hospital on patent management,and find out the problemsand countermeasures for the management.Methods The authorized patents during 2003-2014 of Nanjing Drum Tower Hospital were analyzed statistically,and the date was overall analyzed combined withthe number,type,content,maintenance and transfer of patent and inventors' educational background,title and subject;and results are further analyzed;Results Patent grant increased significantly more than the invention patent in recent years.In terms of patent types,most patents are utility model patents,and conversion rate of patent outcome is very low.Conclusions Suggestions are proposed to improve hospital patent management:strengthening the guidance of the management of patent policy;promoting patent work;enhancing the professional quality of patent managers;optimizing the patent management processe andstrengthening the patent examination and data analysis;strengthening strategic cooperation among intellectual property management department,patent agency and biological pharmaceutical enterprises.