Healthy Skepticism Library item: 15920

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Kuehn BM.
Clinical Trials Registry Expands
JAMA 2009 Jul 1; 301:(1):22
http://jama.ama-assn.org/cgi/content/extract/302/1/22

Abstract:

A major expansion of public access to data from clinical trials is under way, as portions of a 2007 law are phased in.

The Food and Drug Administration Amendments Act required all nonpilot clinical trials of drugs, biologics, or devices regulated by the US Food and Drug Administration (FDA) to be registered at clinicaltrials.gov. Also, starting in September 2008, basic results from trials involving FDA-approved products were to be posted on the Web site.
Deborah A. Zarin, MD, director of clinicaltrials.gov, recently spoke with JAMA about the expansion of the database.

JAMA: Which data must be included in the basic results?

Dr Zarin: The basic results include participant flow, a table of key demographic information about the patients, and tables for each prespecified primary and secondary outcome. For each outcome measure, [the researchers] must post the summary results and may include statistical analyses.

We ask . . .