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 data sharing commitments reflect EFPIA member companies’ strong support for sharing clinical trial data to foster scientific research. The initiative has been welcomed by the EU’s research community.
 
“We look forward to working with these important stakeholders to ensure that our data-sharing regime in Europe continues to promote research excellence and competitiveness.”
 
Richard Bergstrom, director-general, EFPIA.

 

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.

 

 

Reference links:

Data sharing commitments enhance research and scientific knowledge, advance patient care and improve public health (PhRMA statement).

Principles for responsible clinical trial data sharing (EFPIA/PhRMA code of practice).

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