Bill Would Require Disclosure of Clinical Trial Results in Electronic Database, USA

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Medical News Today 02 Mar 2005

Bill Would Require Disclosure of Clinical Trial Results in Electronic Database,

USA

Pharmaceutical and medical device companies would be required to report the

results of all clinical trials on a public, electronic database under

legislation introduced Monday by... Senate Finance Committee Chair Chuck

Grassley (R-Iowa) and three Democratic legislators, Reuters/New York Times

reports. The bill calls for the creation of a database that would include

information about clinical trial outcomes, funding, potential drug side effects

and participants' demographic information (Reuters/New York Times, 3/1). Under

current law, pharmaceutical companies must post data on a government Web site

only for trials that involve treatments for life-threatening diseases or

conditions. Drug companies must inform FDA of all clinical trials performed in

the United States, but they only have to make public the date if the trials are

part of an FDA application for approval (Kaiser Daily Health Policy Report,

1/10). Grassley said, " Increased transparence and openness can lead to greater

accountability, and, ultimately, safer drugs and increased consumer confidence. "

Pharmaceutical Research and Manufacturers of America representatives were

unavailable to comment on the bill (Reuters, 2/28). WAMU's " The Diane Rehm Show "

on Tuesday is scheduled to include an interview with Grassley in the first hour

of the program about several issues, including FDA's drug safety monitoring

(Rehm, " The Diane Rehm Show, " WAMU, 3/1).