TY - JOUR
T1 - Fostering EMA's transparency policy
AU - Banzi, Rita
AU - Bertele', Vittorio
AU - Demotes-Mainard, Jacques
AU - Garattini, Silvio
AU - Gluud, Christian
AU - Kubiak, Christine
AU - Ohmann, Christian
N1 - Copyright © 2014 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.
PY - 2014/9/5
Y1 - 2014/9/5
N2 - 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.
AB - 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.
U2 - 10.1016/j.ejim.2014.07.012
DO - 10.1016/j.ejim.2014.07.012
M3 - Journal article
C2 - 25200801
SN - 0953-6205
VL - 25
SP - 681
EP - 684
JO - European Journal of Internal Medicine
JF - European Journal of Internal Medicine
IS - 8
ER -