Quality of phase I clinical drug trials: Influence of organizational management factors

2020 ◽  
Vol 45 (5) ◽  
pp. 968-975
Author(s):  
Yang Zhao ◽  
Qiuxia Yang ◽  
Xinping Zhang
Keyword(s):  
Phase I ◽  
Organizational Management ◽  
Drug Trials ◽  
Clinical Drug Trials ◽  
Management Factors ◽  
Clinical Drug

scholarly journals Analysis on the influence of the proportion and growth rate of different categories of drug clinical trial research funds on quality improvement in China recently six years

2019 ◽  
Author(s):  
Liran Chen ◽  
Huafang Chen
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Quality Improvement ◽  
Drug Trials ◽  
Clinical Drug Trials ◽  
The Cost ◽  
Self Examination ◽  
The Impact ◽  
Clinical Drug

Abstract Background: The China food and drug administration (CFDA) issued the Announcement of Self-examination and Inspection of Clinical Drug Trial Data on July 22, 2015. Great changes have taken place since the launch of the most stringent drug registration self-examination and inspection in history; the cost of clinical trials is one of the important changes. Methods: The paper compares the changes in the cost of clinical drug trials on both the number and the structure of the trials 3 years before and 3 years after self-examination and inspection were initiated by the CFDA,analyzes the impact on the cost of the clinical research coordinator ( CRC ), the labor service of researchers, audit companies, institutional drug management and quality control on the quality improvement of clinical drug trials. Conclusions: According to the article, the emergence and increase in most clinical trial costs are conducive to the quality enhancement of clinical drug trials,However, the emergence and continued increase of CRC costs can improve the quality of clinical drug trials in some ways and hinder it in others..To improve the quality of clinical trials, China must regulate the booming site management organization ( SMO ) market and actively formulate industry standards and qualification certifications for CRCs.

Methodology of Clinical Drug Trials.

1995 ◽  
Vol 90 (429) ◽  
pp. 390
Author(s):  
Ralph B. D'Agostino ◽  
Alain Spriet ◽  
Therese Dupin-Spriet ◽  
Pierre Simon ◽  
Robert Coluzzi ◽  
...  
Keyword(s):  
Drug Trials ◽  
Clinical Drug Trials ◽  
Clinical Drug

scholarly journals Clinical Drug Trials on Human Beings viz-a-viz Sanctions related to Animal Experimentation: Need to do Introspection?

2012 ◽  
Vol 46 (3) ◽  
pp. 113-116
Author(s):  
Roosy Aulakh ◽  
Chander Shekhar Gautam ◽  
Prabhjot Singh Cheema
Keyword(s):  
Animal Experimentation ◽  
New Drugs ◽  
Drug Trials ◽  
Human Beings ◽  
Animal Protection ◽  
Research Organizations ◽  
Legal Sanctions ◽  
Clinical Drug Trials ◽  
Health Care Law ◽  
Clinical Drug

ABSTRACT Health care law is totally localized in its nature, but research for the development of new drugs has crossed man-made geographical limits. Weaker legal sanctions, poverty, illiteracy and inaccessibility to legal system have all contributed to make India a favored hub for contact research organizations. Many recent clinical drug trials in India have sparked controversy. However, in India today, we are more bothered about animal protection, but show little concern for volunteers in human trials. It is gradually becoming difficult to conduct research on animals; however, research on human beings is far easier. Sanctions against violation of rights of human volunteers in clinical trials are often only a perceived phenomenon. They are not protected as they should be. Regulatory framework needs thorough introspection, debate, reconsideration and strict implementation. These guidelines should not only be recommendatory but mandatory in nature and those who indulge in violations, shall be punished as per the law of the land effectively. How to cite this article Gautam CS, Aulakh R, Cheema PS. Clinical Drug Trials on Human Beings viz-a-viz Sanctions related to Animal Experimentation: Need to do Introspection? J Postgrad Med Edu Res 2012;46(3):113-116.

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