Clinical trial transparency – new code takes effect
New transparency guidelines are in effect that compel pharmaceutical companies to make publicly available the synopses of clinical study reports.
The minimum levels of clinical data sharing are set out in a voluntary code that came into force on January 1st, agreed jointly between EFPIA and PhRMA (the European Federation of Pharmaceutical Industries and Associations, and Pharmaceutical Research and Manufacturers of America).
The new code enables researchers to make applications to the independent scientific review boards that pharmaceutical companies subscribing to the guidance have set up to approve conditions under which scientists are now able to access patient level data, protocols and clinical study reports for future medicines approved by the regulators in Europe and the USA.
The industry’s move towards transparency comes as politicians last week criticised the levels of data sharing – see Trial data transparency under fire from UK parliamentary committee.
Principles for responsible clinical trial data sharing (EFPIA/PhRMA code of practice).
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