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Eur J Intern Med. 2014 Oct;25(8):681-4. doi: 10.1016/j.ejim.2014.07.012. Epub 2014 Sep 6.

Fostering EMA's transparency policy.

Author information

1
IRCCS-Istituto di Ricerche Farmacologiche Mario Negri, via Giuseppe La Masa 19, 20156 Milano, Italy. Electronic address: rita.banzi@marionegri.it.
2
IRCCS-Istituto di Ricerche Farmacologiche Mario Negri, via Giuseppe La Masa 19, 20156 Milano, Italy.
3
European Clinical Research Infrastructure Network, Biopark, 5-7 rue Watt 75013 Paris, France.
4
The Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
5
Coordination Centre for Clinical Trials, Medical Faculty, Heinrich-Heine-University, Moorenstr. 5, 40225 Düsseldorf, Germany.

Abstract

The European Medicines Agency has opened a window to access clinical trial data. This is an important step forward which deserves attention, support, and advice from all the stakeholders. Regulatory agencies are the most comprehensive repositories of clinical trial data on drugs and can also promote and develop standard practices for data sharing. The release of the EMA draft policy on publication and access to clinical trial data in 2013 has fueled a lively debate among academia, industry, and the public in general that is still ongoing. As clinical researchers and producers and users of clinical trial data, we endorse the European Medicines Agency's opening and offer a few suggestions for complete, safe, and effective data sharing.

KEYWORDS:

Clinical trials; Drug regulation; Ethics; Independent clinical research; Individual-patient data; Transparency

PMID:
25200801
DOI:
10.1016/j.ejim.2014.07.012
[Indexed for MEDLINE]

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