Open Access News

News from the open access movement


Friday, October 15, 2004

More on OA to drug trial data

Five Democratic senators have introduced the Fair Access to Clinical Trials Act. Excerpt from their press release (October 7, 2004): "In light of recent revelations that patients may have been harmed by the suppression of data from studies of medicines, Senators Chris Dodd (D-CT), Edward Kennedy (D-MA), Tim Johnson (D-SD) and Ron Wyden (D-OR), and Congressman Edward Markey (D-MA) and Congressman Henry Waxman (D-CA) today introduced the Fair Access to Clinical Trials (FACT) Act to ensure that physicians, patients, and the public have access to basic information about research studies on health care products and medicines. The law would apply to clinical trials for drugs and medical devices, and would require researchers to report all results as well as information for patients seeking to enroll in studies....'Patients suffer when drug companies cherry-pick the data about their products,' said Waxman. 'This bill will stop the industry from manipulating access to medical data.'...The FACT Act would create a clinical trials registry – an electronic database – for drugs, biological products, and medical devices. Such a registry will ensure that physicians, the general public, and patients seeking to enroll in clinical trials have access to basic information about those trials, and doctors have all the necessary information to make appropriate treatment decisions for their patients....Results of clinical trials are expected to be made available and maintained via ClinicalTrials.gov, a website established in 1997 and run by the National Library of Medicine at the National Institutes of Health."

(PS: The text of FACT is not yet on THOMAS, but I'll blog the URL as soon as it's available. ClinicalTrials.gov is OA and meets the International Committee of Medical Journal Editors conditions for an OA registry and database. Reminder that technology is cool: I wrote half of this blog posting on the sidewalk outside the Public Knowledge building in Washington during a fire drill.)