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clinical study reports
from the U.S. National Institutes of Health
Reports on the
FDA's Transparency Initiative
February 13, 2015, the US DHHS and NIH announced a
draft NIH policy
on dissemination of NIH-funded clinical trial information.
Cochrane Central Register of Controlled Trials (CCRCT)
CCRCT (also called CENTRAL) is the Cochrane Collaboration's register of reports of studies that may be relevant for inclusion in Cochrane [Systematic] Reviews. CENTRAL aims to include all relevant reports that have been identified through the work of The Cochrane Collaboration, through the transfer of this information to the US Cochrane Center. It is one of the databases that comprise The Cochrane Library and is currently licensed through EBSCO.
the European Medicines Agency’s European Clinical Trials Database
Must register to access data. Clinical trial data available from May 1, 2004 - present.
From January 1, 2015 forward, the EMA will publish all clinical reports contained in drug applications submitted to the agency. Reports will be published as soon as a decision is published on an application.
International Clinical Trials Registry Platform Search Portal
maintained by the World Health Organization (WHO)
Includes data imported:
Every week from:
Australian New Zealand Clinical Trials Registry
EU Clinical Trials Register (EU-CTR)
International Standard Randomised Controlled Trial Number Register (ISRCTN)
Every 4 weeks from:
Brazilian Clinical Trials Registry (ReBec)
Chinese Clinical Trial Registry
Clinical Trials Registry - India
Clinical Research Information Service - Republic of Korea
Cuban Public Registry of Clinical Trials
German Clinical Trials Register
Iranian Registry of Clinical Trials
Japan Primary Registries Network
Pan African Clinical Trial Registry
Sri Lanka Clinical Trials Registry
The Netherlands National Trial Register
Thai Clinical Trials Register (TCTR)
Access to Janssen Clinical Trial Data
for Janssen, the pharmaceutical company of Johnson & Johnson.
Clinical Study Data Request.com
Portal for clinical trial data from participating pharmaceutical companies (Click on the links, for inclusion criteria for each company):
(Phase 1-4 studies, completed after Jan. 2010 on products and indications approved in the US and/or EU.)
Glaxo Smith Kline
(Phase 2, 3, or 4 studies submitted on or after 1999, or with a first patient visit after Jan 1, 2014. Additional studies outside of this scope may be proactively listed by Lilly.)
(January 2014-present; phase 2 & 3 trials only)
(January 1, 2005-present)
(Includes clinical studies that were considered pivotal for regulatory approval of cerolizumab pegol, cacosamide, rotigotine and levetiracetam. Requests for access to additional clinical study data will be considered on a case-by-case basis.)
SynRG Orange Papers
summarize Russian clinical trial research on a quarterly basis, in English & Russian, from 2006 to the present, and are published by Synergy Research Group, a Russian contract research organization.
Yale University Open Data Access Project (YODA)
from the Yale School of Medicine Center for Outcomes Research & Evaluation (CORE). Trials conducted by Johnson & Johnson and Medtronic, Inc are searchable.
AllTrials is an initiative of Bad Science, the British Medical Journal, the Centre for Evidence-based Medicine, Cochrane Collaboration, James Lind Initiative, PLOS, and Sense About Science and, in the United States, Dartmouth University’s Geisel School of Medicine and the Dartmouth Institute for Health Policy & Clinical Practice.
The Journey of Clinical Trials.
Doshi P, Jefferson T, Del Mar C.
The Imperative to Share Clinical Study Reports: Recommendations from the Tamiflu Experience
. 2012;9(4):e1001201. doi:10.1371/journal.pmed.1001201.
Guidance for Industry: Structure and Content of Clinical Study Reports
Guidance for Industry: Structure and Content of Clinical Study Reports Questions and Answers
What doctors don’t know about the drugs they prescribe
Institute of Medicine.
Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk
Half of US clinical trials go unpublished
. 2013. doi:10.1038/nature.2013.14286.
Pharmaceutical Research and Manufacturers of America (PhRMA).
Principles for Responsible Clinical Trial Data Sharing
Wieseler B, Wolfram N, McGauran N, et al.
Completeness of Reporting of Patient-Relevant Clinical Trial Outcomes: Comparison of Unpublished Clinical Study Reports with Publicly Available Data
. 2013;10(10):e1001526. doi:10.1371/journal.pmed.1001526.
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