EFPIA, PhRMA Release Joint Principles For Clinical Trial Data-Sharing, To Criticism

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The European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA) endorsed joint principles for clinical trial data-sharing.

The “Principles for Responsible Clinical Trial Data Sharing: Our Commitment to Patients and Researchers,” were announced in a jointly issued press release.

The principles were endorsed on 24 July and are published on the websites of both EFPIA and PhRMA.

Under the new data sharing commitments, biopharmaceutical companies that are members of EFPIA and PhRMA will increase the information made available to patients, researchers and the public.

The commitments will see patient- and study-level clinical trial data and clinical trial study reports shared with qualified scientific and medical researchers. Synopses of trial results will also be made available to patients who participated in the trials.

The information made available will be subject to patient privacy and commercial confidentiality conditions.

Meanwhile, Health Action International (HAI) Europe criticised these joint principles. In a 25 July statement, HAI Europe Policy Advisor Ancel-la Santos Quintano said they “fall woefully short of the data transparency that is needed.”

In its statement, HAI Europe advocated mandatory public disclosure of clinical trial data and the creation of a publicly accessible database where all clinical data can be accessed. It criticised the EFPIA-PhRMA proposals to only make synopses of clinical study results available, rather than the full results.

Other criticisms were limitations placed on information available, and commercial confidentiality restrictions, which it said runs contrary to European standards for clinical trial data.

Caitlin McGivern is currently studying at the University of Law in London and will graduate with an LLM in 2014. She previously obtained a Bachelor’s of Arts in Philosophy and Theology from the University of Oxford. She is a summer intern at Intellectual Property Watch. She is of Swiss, Canadian and Irish nationalities.

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Comments

  1. says

    I think this is such a great idea, data sharing can give way to a more successful clinical trials and can help a lot in the improvement of health.

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