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The Status Quo And Countermeasures Of Drug Clinical Trials In Beijing

Posted on:2018-08-21Degree:MasterType:Thesis
Country:ChinaCandidate:S ZhongFull Text:PDF
GTID:2354330515981120Subject:Chinese materia medica
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A clinical trial of a drug is a systematic study of any of the drugs in the human body(patients or healthy volunteers)to determine the safety and efficacy of the drug.After more than thirty years of continuous development,our country has made great progress in drug clinical trial,also exposed a lot of problems.At present,there are many researches on quality control and quality control of clinical trials in China.However,there are few statistical analysis on the clinical trial institutions and professionals in China.Statistics can only be found 2014.According to reports,the number of qualified drug clinical trial institutions in Beijing ranks first in the country,and has a wide coverage of professionals.While,there is little research on the current situation of clinical trials in Beijing.Therefore,the purpose of this study is to conduct the latest statistics of the drug clinical trial institutions and professional in our country and analysis the common problems in drug clinical trial institution.As to improve and enhance the comprehensive competitiveness of drug clinical trials in China,Implements the role Beijing in drug clinical trials in the development of clinical trials.So that can provide countermeasures for the better development of clinical trials in china.This study analyse the current situation of clinical trial in our country by analyse the drug clinical trial institutions and professions of drug clinical trial institution qualification announcement from 2005 to 2017 in CFDA website and interview with researchers,CRC and sponsor in drug clinical trials website.Statistics show that China now has 630 certificated drug clinical trial institution with a total of 4743 professions.However,in the administration of drug clinical trial institution qualification review,6 professional and 4 hospitals did not pass the qualification of drug clinical trial institutions that check qualified clinical testing in 2 medical institutions were canceled.Therefore,at present,there are a total of 628 medical institutions qualified for clinical trials in our country,and there are 4733 professional departments with clinical trials.Among them,Beijing,Shanghai,Guangdong,Jiangsu has top4 clinical trial institution number,accounting for about 34.9%of the total of all clinical trials,clinical trial institutions and professional departments found concentrated in the eastern region,most of the professional department for western medicine,reflect the distribution of health resources in our country the problem of imbalance among them,Beijing City drug clinical trial institution and the number of professional certification number was significantly higher than that in other provinces.Beijing City,a total of 57 clinical trials,found 530 professional departments,110 professional get recognized,clinical trial institution in Beijing city mainly concentrated in the center of Beijing,professional departments also identified with Western based,similar to the development characteristics of drug clinical trial institutions in China and professional.In the past five years,the average annual drug clinical trial in Beijing has been carried out as a professional team of more than and 400,the number of clinical trials has been greatly improved.Clinical trials in China experienced 30 years of development has made gratifying achievements,but also highlights a series of problems.Drug clinical trial institutions still need to strengthen the control ability of clinical trials,improve the level of self-construction.Also,the state should improve rules and regulations,strengthen the supervision function,expand the drug trial team,improve the information construction of drug clinical trials,give Beijing,Shanghai,Guangdong more chance for academic exchanges,so that these drug clinical trial institutions can make greater contribution to the development of the drug clinical trials in china.
Keywords/Search Tags:clinical trial institution, statistics, profession, quality control
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