New England Journal of Medicine Supports Clinical Trial Registry

“Open Clinical Trials,” an editorial in the New England Journal of Medicine, published online October 3, 2007, strongly endorses the provision of the new FDA Revitalization Act  requiring sponsors of all clinical trials to register their studies in a public database sponsored by the National Library of Medicine.

The editorial states,

“A decade ago a clinical trial could be conducted in secret. The trial’s sponsor, claiming proprietary rights, could keep all information about it, including its very existence, private. Thus, if a drug had important adverse effects, this information might never be made public. Legislators believed that such a possibility was not in the best interests of the American people….”

This is important for patients because, “ Once a clinical trial is mounted, the sponsor has an ethical obligation to publicly acknowledge the contribution of the participants and the risk they have taken by ensuring that information about the conduct of the trial and its principal results are in the public domain. With the FDA Revitalization Act, the United States joins other countries in recognizing that the human volunteers needed to complete a trial are more precious than the money required to mount it. Between study subjects and financial sponsors, it is easy to see who is taking the greater risk.”

The editorial calls on potential clinical trial participants to “consider only studies whose sponsors have fully registered them in an appropriate public database and agreed to publish their results.“

Then “research volunteers will know that their participation is part of an unbiased public record.

We think that fully open clinical trials will lead to more effective and safer treatments for patients.”

The Parkinson’s Pipeline Project fully agrees with the New England Journal of Medicine’s editorial. Indeed, registration of clinical trials and  providing the public with full trial data is an important provision of our proposed Clinical Trial Participants Bill of Rights

The full NEJM editorial is available (as of 10/06/07)  at: http://content.nejm.org/cgi/content/full/NEJMe0706501?resourcetype=HWCIT 

Last updated 10/07/07

Better Reporting of Clinical Trial Results Will Speed Development of New Trials,
Enhance Safety of Research Participants, and Promote Practice of
Evidence-Based Medicine

(Click on a topic below to link to that page.)

What are the problems with the reporting of clinical trial results?

What is being done to improve the clinical trial reporting process?

• Mandatory trial registration
• Full disclosure of required information
• Standards for reporting
• Hold public and patient interests above commercial interests Free, timely electronic access to trial protocols and research results
• One centralized source of access

Standards of reporting

• Standards for reporting
• Hold public and patient interests above commercial interests
• Free, timely electronic access to trial protocols and research results

One centralized source of access

• Legislation

Where to find clinical trial results

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All rights reserved. Revised: 10/07/07.