Research On The Resource Sharing Mechanism Of Foreign Clinical Research

With the quick increase of human’s healthcare requirements and the continuous improvement of medical science and technology, the reinforcement of clinical research and application has become an important area related to human’s wellness.As an vital strategic resource of disease diagnosis and treatment, clinical research resource has a pivotal role in the field of clinical research. At present, clinical trial data and biobank are the two main bodies of clinical research resources. With the further development of clinical research, the sharing of abundant clinical research resource has become a major challenge. The sharing mechanism of clinical research resources has already formed in the united states. America is on the front rank in the clinical trial data and biobank. Britainand other European Union countries have successively put forward the model of clinical research resources sharing. In contrast,the sharing of clinical research resources is still in its infancy in China. The sharing mechanism of clinical research resources is not comprehensive, clinical trial data scattered, biobank is a single, there are still flawed in many ways and areas for improvement. Should learn from foreign experiences and lessons of sharing mechanism, which will help promote the development of clinical research.This paper mainly adopts the methods of literature research, systems analysis,comprehensive analysis, expert consultation and benchmarking research. In order to analyses occurrence and development of sharing mechanism, we should keep a firm grasp on the problems and difficulties faced by our country. From two main body of clinical trial data and biobank, this thesis discusses the current situation of foreign clinical research resources sharing mechanism; Analysis and evaluation of foreign experience and the characteristics of clinical research resources sharing mechanism;On the basis of combing the status of clinical research resources sharing mechanism in our country, analyses the existing problems and put forward the construction of the mechanism of clinical research resources sharing in our country. Based on clinical research abroad resource sharing system of scanning, found that led the world in America, Britain and the European Union, to establish a good mechanism of sharing,so the thesis mainly to the above three countries and regions are analyzed in focus.This paper is divided into six parts.The first part, which is about analyzing clinical research resources, explains what these are and the significance of research. This chapter is made up of two parts:clinical trial data and biobank. Adopt the method of literature research and qualitative research combing the basic content of clinical research resources theory and the research significance, the establishment and perfection of the sharing mechanism.With the rapid development of medical big data and datagenomics, clinical trial data and biobank as an important part of clinical research resources. In order to effectively carry out research, this part focus on the basic theory of clinical trial data and biobank,summarized the significance of the analysis and research.The second part, studing of the clinical research resources sharing mechanism,analyzed the various stages of clinical trials, the environment of data sharing, the north American clinical trial data center platform construction and the guarantee of policy and regulations in United States. Discusses the feature of the biobank construction and management and the American society of clinical research collaborative networks in terms of sharing mechanism and research results were analyzed emphatically, discussing the development trend of the clinical research resources sharing mechanism in the United States.The third part, studing of clinical research resources sharing present situation and features in England, including the clinical trial data sharing power and obstacles, the Care. data platform for the construction of the project and the corresponding policies and regulations. The biobank as one of the world’s largest population sample library,in the sample for the construction of resource sharing and management measures has a wealth of experience, through to its characteristics, management mode and related policy laws and regulations, analyzes its practical significance.In addition to the clinical research network construction and management are analyzed, summarized the clinical research network’s efforts in realize resources sharing.The fourth part, analyzing the clinical research resources sharing of the European Union, and focuses on the strategic planning, policies and regulations in EU clinical trials sharing mechanism. Analyzing the model of the EU clinical trials database.Against the EU biobank, study of the feature and management about the EU rare disease biology database and the biobanking and molecular research infrastructure,summary of the European Union in the biobank construction and management.The fifth part, analyzing the clinical research resources sharing mode in our country, exploring the content in the clinical trial data sharing,biobank and the national center for clinical research. Analysis of our country in the aspect of clinical research resources sharing and needs, find the insufficiency and experience of clinical research resources sharing in China.The sixth part, in view of our country in clinical trials data sharing and biobank construction management problems and challenges, the comprehensive analysis of resource sharing mode of clinical research in China and abroad. And on this basis,analyze and research to the current situation and the development of clinical research resources sharing, put forward the corresponding countermeasure and suggestion.