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The Analysis Of The Factors Affecting Subjects Recruited In New Clinical Trials

Posted on:2016-04-23Degree:MasterType:Thesis
Country:ChinaCandidate:K YanFull Text:PDF
GTID:2284330470463756Subject:Social Medicine and Health Management
Abstract/Summary:PDF Full Text Request
Objective:To improve the methods of drug clinical trial recruitment, increase the success of recruitment, enhance the advertisement normative, promote the recruited efficiency of medicine subjects in clinical trial, promote the development of drug clinical trials methods:Through literature research, data statistics and comparative analysis, questionnaire investigation, to reveal huge problems of drug clinical trial recruitment and combine with domestic and foreign outstanding experience, analyses the causes of the problems, puts forward the rationalization proposal Results:China has the biggest advantages of development of drug clinical trials, the advantage including a large number of the subjects, a large number of excellent drug clinical trial institution can be selected by drug research and development of enterprises, but the current progress of clinical trials is slowly, the main reason is that there are many problems existing in the subjects link, subjects were recruited from a single mode, the efficiency is low; the recruitment advertisement without ethics committee review, the recruitment of language are not in conformity with the specifications, there are more seductive language but little for protection the interests of subjects. conclusion: Suggestions on the subject recruitment laws and regulations and guidelines should be published by pharmaceutical sector as soon as possible, to improve participant recruitment fundamentally; Recommended the establishment of clinical trials of drug quality management system, increasing the responsibilities of the Ethics Committee, and the Ethics Committee should play the role of protection for participants; Recommended the establishment of a third-party organization to recruit subjects, standing welfare point of view, effective, rational organization subjects participating in clinical trials of drugs to improve the situation of disadvantaged subjects; To raise people’s awareness of the drug in clinical trials, the clinical trials should be as a course for university student, carry forward the spirit of the clinical trials and promote the development of drugs for clinical trials...
Keywords/Search Tags:Clinical trial, Ethics Committee, Subjects Recruit methods, Recruit advertising
PDF Full Text Request
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