"Is ClinicalTrials.gov Breaking the Law?"

By Harold Miller-Jacobs and Norman M. Goldfarb

The Food and Drug Modernization Act of 1997 called for “a registry of clinical trials… in a form that can be readily understood by members of the public.” (§ 113(a)) Three years later, in 2000, ClinicalTrials.gov (http://www.clinicaltrials.gov/) was in operation. According to the developers:

“All stages of system development were guided by the needs of the primary intended audience, patients and other members of the public… To reach the broadest audience with the fewest barriers to access, we designed a Web-based system that would be easy even for a novice user to use and yet would have extensive functionality. The goal was to make it simple for users to formulate their queries and then obtain results that would guide them to further relevant, ‘just-intime’ information. We involved patients and patient advocates in the early testing of the system, and we identified and then tested our site for accessibility using several readily available tools, also making sure that the system performs reasonably on a wide range of Web browsers.”

Today, over six years later, ClinicalTrials.gov is, by far, the leading clinical trials registry. Over 29,000 people visit the website daily to learn about over 31,000 clinical trials. However, has it achieved its goals for ease-of-use by the public? To find, out let’s follow Roger, a hypothetical member of the public, as he seeks information at ClinicalTrials.gov.

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Journal of Clinical Research Best Practices
Vol. 2, No. 12, December 2006
"Can You Handle the Truth?"