[HTML][HTML] Secrecy or transparency? The future of regulatory trial data

B Wieseler, N McGauran - CMAJ, 2017 - Can Med Assoc
We don't think so—with all of the data being publicly available, different opinions can now be
discussed openly. Concerning the transparency of clinical trial information from regulatory …

[HTML][HTML] North American regulatory agencies can and should make clinical trial data publicly available

N Persaud, P Doshi - CMAJ, 2016 - Can Med Assoc
Regulatory agencies such as Health Can ada and the US Food and Drug Adminis tration
(FDA) have to date treated sub missions of clinical trial data as confidential business …

Clinical Trial Transparency: The FDA Should and Can Do More

A Kapczynski, J Kim - The Journal of Law, Medicine & Ethics, 2017 - journals.sagepub.com
The Blueprint for Transparency at the FDA recommends that the FDA proactively release
more clinical trial data. We show that the FDA possesses the legal authority to act on this …

[HTML][HTML] More transparency for clinical trial data: the decision by the European Medicines Agency to make clinical trial reports publicly available could provide a boon …

P Hunter - EMBO reports, 2015 - embopress.org
details about commercially sensitive data, the real problem for granting unfettered access to
clinical trial data is patient confidentiality. EMA and other regulatory bodies were still …

European drug agency works to improve transparency, but skepticism remains

T Hampton - JAMA, 2012 - jamanetwork.com
FOLLOWING CONSIDERABLE PRESSURE over policies related to the accessibility of
unpublished clinical trial data in its database and conflicts of interest for its officials …

[HTML][HTML] Transparency and the European Medicines Agency—sharing of clinical trial data

S Bonini, HG Eichler, N Wathion… - New England Journal of …, 2014 - Mass Medical Soc
Transparency and the European Medicines Agency — Sharing of Clinical Trial Data | NEJM
Skip to main content NEJM Group Follow Us Facebook Twitter Instagram YouTube LinkedIn …

The evolution in registration of clinical trials: a chronicle of the historical calls and current initiatives promoting transparency

C Pansieri, C Pandolfini, M Bonati - European journal of clinical …, 2015 - Springer
Purpose Quality of care is strongly influenced by evidence-based medicine, a large part of
which is based on results obtained from clinical trials. If trials are conducted in secret, patient …

Clinical trial transparency: a reassessment of industry compliance with clinical trial registration and reporting requirements in the United States

SM Lassman, OM Shopshear, I Jazic, J Ulrich… - BMJ open, 2017 - bmjopen.bmj.com
Objective To evaluate the accuracy of a 2015 cross-sectional analysis published in the BMJ
Open which reported that pharmaceutical industry compliance with clinical trial registration …

[PDF][PDF] Clinical trial disclosure: the ongoing debate on public registers for clinical trials

KB Thomas, C Tesch - J Euro Med Writ Assoc, 2007 - emwa.org
The loss of public trust in the clinical research community, particularly in the pharmaceutical
industry, came after a series of allegations focusing on selective reporting of clinical trial …

Fostering EMA's transparency policy

R Banzi, J Demotes-Mainard, S Garattini… - European Journal of …, 2014 - Elsevier
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 …