Better Reporting of Clinical Trial Results
Where to find clinical trial results
Website :Pub Med
National Institutes of Health, PubMed Central URL:
http://www.pubmedcentral.nih.gov
Description: The PubMed website provides searchable access to the MEDLINE
database, which includes citations to and abstracts of over 4800 biomedical
journals worldwide. In some cases, links to free full-text articles that are
archived in the NIH’s PubMedCentral.
Clinical Trial Coverage: Articles reporting on clinical trials that have
been submitted by researchers and published in biomedical journals. It is
not required that results of all trials are published, and those with
negative results often are not.
Dates covered: 1960’s - Present
Timeliness: There is often a lag of a few months, or even longer, between
the conclusion of a clinical trial and the publication of the results in a
journal.
Website : Pharma Clinical Study Results Database
URL : www.ClinicalStudyresults.org
Description: The ClinicalStudyResults.org site is a central, web-based
repository for ‘hypothesis testing” (mainly phase III and IV) clinical study
results for trials sponsored by pharmaceutical companies. Citations to
journal articles and full text of unpublished company studies where
available, are provided. Summaries of unpublished studies will include
information on trial design, patients studied, dose and mode of
administration and a summary of conclusions and outcomes on safety and
efficacy.
Clinical Trial Coverage: As of December 2005, there were 9 entries for
Parkinson’s Disease clinical trials, all were from 2 companies – Lily and GSK. Participation by companies in this database is voluntary.
Dates Covered: October 2002 - Present
Timeliness: “References to scientific papers will be posted when they are
published. In accordance with FDA’s annual report regulations, PhRMA will
urge companies to post unpublished study summaries within one year of
completion.”
Website : BioMedCentral
URL: http://www.biomedcentral.com
Description: “BioMed Central is an independent publishing house committed to
providing immediate open access to peer-reviewed biomedical research. BioMed
Central views open access to research as essential in order to ensure the
rapid and efficient communication of research findings. “ Over 130 journals
on various medical and bioscientific subjects are now available through BMC.
Many are freely available. Some require subscriptions.
Clinical trial coverage: varies by journal.
Dates covered: varies by journal
Timeliness: “All research articles in BioMed Central's journals receive
rapid and thorough peer review. All original research articles published by
BioMed Central are made freely and permanently accessible online immediately
upon publication.”
Website : Public library of science
URL: http://www.plos.org/index.html
Description: “The Public Library of Science (PLoS) is a nonprofit
organization of scientists and physicians committed to making the world's
scientific and medical literature a public resource. PLoS provides
scientists and physicians with high-quality, high-profile journals in which
to publish their most important work, while making the full contents freely
available for anyone to read, distribute, or use for their own research.”
Clinical Trial coverage: Varies by journal. A new journal, PLoS Clinical
Trials, debuts in Spring 2006, “devoted to peer-reviewing and publishing
reports of randomized clinical trials in all areas of healthcare. “ SEE:
www.plosclinicaltrials.org.
Dates Covered: 2003 – Present
Timeliness: “Under the open access model, PLoS makes all published works
immediately available online.”
Web site : Global trial bank (under development)
URL: http://globaltrialbank.org/
Description: “Global Trial Bank (GTB) is being developed by the American
Medical Informatics Association (AMIA, www.amia.org) to become the world’s
peer-reviewed repository of protocols and results from clinical trials of
all types. “
Clinical Trial Coverage: “GTB aims to include all clinical trials from all
sponsors worldwide. This includes trials conducted by universities,
government, and pharmaceutical and other companies. The focus will be on
hypothesis-testing randomized trials, but will also accept early phase
exploratory trials. GTB will also accept trials that were completed and
reported before GTB’s launch.”
”All GTB entries will include a minimum set of information about the study’s
protocol and results, to enable critical appraisal of the trial’s methods,
analyses, and results. “
Dates covered: July 1, 2005 - Present
Timeliness: “The expectation is that trial investigators will report the
minimum set of protocol information into GTB within a month after the trial
is registered with an approved registry. Investigators will also be
encouraged to report protocol amendments to GTB as they occur or at the time
results are reported. The minimum set of results information is expected to
be reported to GTB within 3 years after trial completion, with allowances
for studies that are under peer review at a journal.”
Sources
(1) Graham, Rod.
Clinical Trials Registration: Overdue yet Elusive. Johns
Hopkins Bloomberg School of Public Health, July 7, 2005 .
www.jhsph.edu/publichealthnews/ articles/2005/dickersin.html
(2) McDonald, Dan and Molinari,
Paul. Breaking the Trial Result Disclosure Logjam Now . Applied
Clinical Trials, July 1, 2005. Retrieved online: January 2, 2006
http://www.actmagazine.com/
(3) Principles for Protecting Integrity in the Conduct and Reporting of
Clinical Trials,
Approved by AAMC Executive Committee, September 15, 2005. Retrieved online:
January 2, 2006
http://www.aamc.org/research/clinicaltrialsreporting/clinicaltrialsreporting.pdf
(4)
AAMC Adopts New Principles for Reporting Results of Clinical Trials (press
release), October 31, 2005. Retrieved online: : January 2, 2006
http://www.aamc.org/newsroom/pressrel/2005/051031.htm
(5) Veitch, Emma.
Tackling Publication Bias in Clinical Trial Reporting, PLoS
announces the launch of a new online journal PloS Medicine, Volume 2, Issue
10, October 2005. Retrieved online: : January 2, 2006
http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0020367
(6) Announcing PloS Clinical Trials. Retrieved online Jan. 2, 2006:
http://clinicaltrials.plosjournals.org/
(7) Krleza-Jeric, Karmela . Clinical Trial Registration: The Differing
Views of Industry, the WHO, and the Ottawa Group. Public Library of
Science. Volume 2, issue 11, November 2005. Retrieved online: : January 2,
2006
http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0020378
(8) World Health Organization. International Clinical Trials Registry
Platform. Retrieved online: : January 2, 2006
http://www.who.int/ictrp/en
(9)
Academic Research Leaders Meet with NIH’s Zerhouni : Pledged Firm Support
for NIH Public Access Policy and Six-Month Window. (Press Release) November
16, 2004. Retrieved online: January 2, 2006
https://mx2.arl.org/Lists/SPARC-OAForum/Message/1300.html
(10)
Mandatory public clinical drug trial registry needed to help ensure
prescription drug safety, IOM panel told. Consumers Union Prescription for
Change. June 27, 2005. Retrieved online: January 2, 2006
http://www.consumersunion.org/campaigns/pfc01afederal_clinical_drug_trial_registry/002449indiv.html
(11) Marchione,
Marilynn. Drug Firms Making Public More Data on Medical Studies, but
Some Hold Key Details, Analysis Finds. Dec 28, 2005
(12) Office of Legislative Policy Bill Tracking. S. 470—The Fair Access to
Clinical Trials (FACT) Act. Retrieved online: December 29, 2005
http://olpa.od.nih.gov/tracking/109/senate_bills/session1/s-470.asp
(13) Ottawa Statement on Trial Registration. Retrieved online: December 30,
2005: http://ottawagroup.ohri.ca/index.html
(14) Susman,
Ed. Boycott of secretive drug trials sought. Science Daily.
December 30, 2005 . Retrieved online: January 2, 2006
http://www.sciencedaily.com
(15) Zarin, Deborah A., Tse, Tony and Ide, Nicholas C. Trial Registration at
ClinicalTrials.gov between May and October 2005. New England Journal of
Medicine. Vol. 353, no. 26 :2779-2787, December 29, 2005 . Retrieved online:
January 2, 2006
http://content.nejm.org/cgi/content/full/353/26/2779
(16)
Why should clinical trials be registered? (editorial) CMAJ.
June21, 2005. Retrieved online: January 2, 2006
http://www.cmaj.ca/cgi/content/full/172/13/1653
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