title: Fostering EMA's transparency policy.
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.
authors.affiliation: IRCCS-Istituto di Ricerche Farmacologiche Mario Negri, via Giuseppe La Masa 19, 20156 Milano, Italy. Electronic address: rita.banzi@marionegri.it.
authors.forename: Rita
authors.initials: R
authors.lastname: Banzi
authors.affiliation: IRCCS-Istituto di Ricerche Farmacologiche Mario Negri, via Giuseppe La Masa 19, 20156 Milano, Italy.
authors.forename: Vittorio
authors.initials: V
authors.lastname: Bertele'
authors.affiliation: European Clinical Research Infrastructure Network, Biopark, 5-7 rue Watt 75013 Paris, France.
authors.forename: Jacques
authors.initials: J
authors.lastname: Demotes-Mainard
authors.affiliation: IRCCS-Istituto di Ricerche Farmacologiche Mario Negri, via Giuseppe La Masa 19, 20156 Milano, Italy.
authors.forename: Silvio
authors.initials: S
authors.lastname: Garattini
authors.affiliation: The Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
authors.forename: Christian
authors.initials: C
authors.lastname: Gluud
authors.affiliation: European Clinical Research Infrastructure Network, Biopark, 5-7 rue Watt 75013 Paris, France.
authors.forename: Christine
authors.initials: C
authors.lastname: Kubiak
authors.affiliation: Coordination Centre for Clinical Trials, Medical Faculty, Heinrich-Heine-University, Moorenstr. 5, 40225 Düsseldorf, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Ohmann
mesh_terms: D022126:Access to Information / Q000941:ethics; D002986:Clinical Trials as Topic / Q000592:standards; D004345:Drug Industry / Q000458:organization & administration; D005062:European Union; D006077:Government Agencies; D006801:Humans; D033181:Information Dissemination / Q000941:ethics; D011050:Policy Making
keywords: Clinical trials; Drug regulation; Ethics; Independent clinical research; Individual-patient data; Transparency