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InfoTrials, the publication of clinical trials

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JOINT POSITION
 
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JOINT POSITION

The most important international pharmaceutical associations (among which the European Federation of Pharmaceutical Industries and Associations – EFPIA and the Pharmaceutical Research and Manufacturers of America) have initialized an agreement that intends to make the information on clinical trial results available to everyone. 
The "Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Database" will provide a world register on a voluntary basis for clinical trials regarding new prescription drugs.
A synthetic version of the results will need to be accessible for free on public databases, whether the study results are positive or negative, for any drug on the market in at least one country.

"In 2004 the pharmaceutical companies have been for example charged for making only positive trials stand out and hiding negative data. The program will now ensure total transparency,” Brian Ager, General Director of EFPIA, declared. 

The results of clinical trials will be published in a standard format that will include a description of the project and of the methodology used, the results of the primary and secondary protocol measurements, the safety data, as well as possible references to related medical publications.

The publication of results will need to respect well-defined timeframes: within a year from the drug approval or, in case of trials following the authorization, within a year from their completion.

 

DOWNLOAD:
Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Database.pdf
 
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