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"Wathion, Noël"
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Transparency and the European Medicines Agency — Sharing of Clinical Trial Data
by
Wathion, Noël
,
Bonini, Sergio
,
Rasi, Guido
in
Brandeis, Louis D (1856-1941)
,
Clinical trials
,
Clinical Trials as Topic - standards
2014
Guided by public health interests, the European Medicines Agency has set new standards for clinical trial data transparency by adopting a 2010 policy on access to documents and a 2014 policy on publication of clinical data for medicinal products for human use.
Transparency, whether in politics, finance, or science, is a fundamental value of our society. In health care, decisions about medicines made by governments, regulators, and clinicians are, whenever possible, based on clinical trial results. We believe that patients have a right to know about the scientific basis for the approval and use of their medicines and that transparency of clinical trial data is therefore essential.
Over the past 4 years, we at the European Medicines Agency (EMA) have set new standards for clinical trial data transparency by adopting two landmark policies. A 2010 policy on access to documents
1
and a . . .
Journal Article