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 Citations to journal articles and full text of unpublished company studies where available, are provided. Summaries of unpublished studies will include information on trial design, patients studied, dose and mode of administration and a summary of conclusions and outcomes on safety and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 In accordance with FDA’s annual report regulations, PhRMA will urge companies to post unpublished study summaries within one year of completion.”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. “

Dates Covered: 2003 – Present

Timeliness: “Under the open access model, PLoS makes all published works immediately available online.”

Web site : Global trial bank

URL: https://www.amia.org/global-trial-bank

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.”

 

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Sources

(1) Graham, Rod. Clinical Trials Registration: Overdue yet Elusive. Johns Hopkins Bloomberg School of Public Health, July 7, 2005 .

(2) McDonald, Dan and Molinari, Paul. Breaking the Trial Result Disclosure Logjam Now . Applied Clinical Trials, July 1, 2005. Retrieved online: January 2, 2006

(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

(4) AAMC Adopts New Principles for Reporting Results of Clinical Trials (press release), October 31, 2005. Retrieved online: : January 2, 2006 [12/09; item online; required login]

(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

(6) Announcing PloS Clinical Trials. Retrieved online Jan. 2, 2006

(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

(8) World Health Organization. International Clinical Trials Registry Platform. Retrieved online: : January 2, 2006

(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

(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  ndiv.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 

(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 

(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 

(16) Why should clinical trials be registered? (editorial) CMAJ. June21, 2005. Retrieved online: January 2, 2006