منابع مشابه
Integrity of Scientific Data: Transparency of Clinical Trial Data.
The integrity of the data from clinical trials and of its use is an essential element of the scientific method, and of the trust one can have in this method. There are many examples of fraud, and they recur regularly. The objective of this round table was to work on the definition of fraud, on its recognition and prevention especially in the institutional system. Fraud involves an active decisi...
متن کاملClinical trial transparency: a reassessment of industry compliance with clinical trial registration and reporting requirements in the United States
OBJECTIVE To evaluate the accuracy of a 2015 cross-sectional analysis published in the BMJ Open which reported that pharmaceutical industry compliance with clinical trial registration and results reporting requirements under US law was suboptimal and varied widely among companies. DESIGN We performed a reassessment of the data reported in Miller et al to evaluate whether statutory compliance ...
متن کاملLegislation for trial registration and data transparency
Public confidence in clinical trials has been eroded by data suppression, misrepresentation and manipulation. Although various attempts have been made to achieve universal trial registration- e.g., Declaration of Helsinki, WHO clinical Trial Registry Platform (WHO ICTRP), the International Committee of Medical Journal Editors requirement- they have not succeeded, probably because they lack the ...
متن کاملMeasuring clinical trial transparency: an empirical analysis of newly approved drugs and large pharmaceutical companies
OBJECTIVES To define a series of clinical trial transparency measures and apply them to large pharmaceutical and biotechnology companies and their 2014 FDA-approved drugs. DESIGN Cross-sectional descriptive analysis of all clinical trials supporting 2014 Food and Drugs Administration (FDA)-approved new drug applications (NDAs) for novel drugs sponsored by large companies. DATA SOURCES Data ...
متن کاملRegulatory transparency: social, technical, and ethical aspects of clinical trial data access.
In the field of health regulation, enabling public access to data from clinical trials is a process currently undergoing consolidation by the principal regulators worldwide. This paper discusses recent developments in public policy regarding regulatory transparency, and the risks and benefits of a regulatory impact-analysis on clinical trial reports, from the perspective of the key stakeholders...
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ژورنال
عنوان ژورنال: Canadian Medical Association Journal
سال: 2015
ISSN: 0820-3946,1488-2329
DOI: 10.1503/cmaj.1150063