Analysis of the current status of clinical drug trial institutions in Chongqing and reflections on the establishment of regional institutions / 中国临床药理学与治疗学

AIM: Given the fact that Chongqing is a place rich in medical resource and the government is marking every effort in promoting the reform of drug clinical trial evaluation and the development of medical and health industry, the present study was designed to evaluating the current status of drug clinical research institute in Chongqing by investigating its administrative staff to further find ways for innovative development. METHODS: This study conducted a questionnaire survey on 54 managers from 20 clinical drug trial institutions in our city and systematically analyzed the level of institutions construction in our city by comparing the corresponding public data.RESULTS: Analyze of questionnaire survey revealed that the projected preformed in Chongqing were mainly from domestic pharmaceutical companies (90.00%) while 65%of the institutes took less than 40 projects in the past 3 years. The working seniority of administrative staff were mainly less than 6 years (79.59%) while some of the administrative staff still didn't get systemic training on clinical research. Additionally, public data analyze has revealed that 81 projects were registered as "ongoing" on ClinicalTrails.gov in the past 3 years in 22 drug clinical research institutes in Chongqing, which is much less than that in Beijing (61 institutes, 433 projects) and Shanghai (53 institutes, 326 projects). CONCLUSION: It is of great urgency to promote the development of drug clinical research institutes in Chongqing. The acceleration of innovative development of medical and health industry could be achieved by integrating the city's medical resources and constructing regional drug clinical research institute system.

The quality control of medical devices clinical trials finished by drug clinical research institute office / 中国医学装备

Objective:To ensure the authenticity, scientific and reliability of medical devices clinical trials results.Methods: The drug clinical research institute office set up full-time secondary quality control team, clarified the responsibility, made application form, problem check and track list, subjects’ identity registration form. Using computer network to make 19 medical equipment quality control of clinical trials.Results: Assure the rights and safety of subjects, the validity, accuracy and completeness of clinical trial data and clinical trial results.Conclusion: The drug clinical research institute office, full-time secondary quality control team made strict clinical trial project for the whole process of quality control and ensure the true, scientific and reliable results.