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[e-drug] Fair Access to Clinical Trials Act

E-DRUG: Fair Access to Clinical Trials Act
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[Clinical trials and their outcomes will in the USA have to be registered in a 
public database; enforcement is through Ethics committees who will refuse CT 
protocols unless they are registered. Given the flood of CTs in developing 
countries, similar databases ought to be started and made compulsory there too. 
The logical next step is a GLOBAL database of CTs. Who volunteers? WHO? Copied 
as fair use. WB]

http://bmj.bmjjournals.com/cgi/content/full/329/7473/996-d 
BMJ  2004;329:996 (30 October), doi:10.1136/bmj.329.7473.996-d 
Law is introduced in US Congress to give access to details of clinical trials
Washington, DC Bob Roehr 

Public access to information on clinical trials and their outcomes would become 
universal and unfettered in the United States under a proposed law that was 
introduced in the House of Representatives and the Senate earlier this month.

The Fair Access to Clinical Trials Act would require registration of all human 
clinical trials involving drugs, "biologics" (blood products, vaccines, gene 
therapy tissue, and so on), and medical devices at an online database operated 
by the National Institutes of Health (www.clinicaltrials.gov).

It would require institutional review boards to deny a trial a stamp of 
approval unless it was registered in the database. And it outlines the types of 
information that would have to be provided under that registration.

Results of a trial would also have to be deposited in the database, generally 
within 12 months of the trial's completion. Other provisions call for periodic 
updates of additional information, including the submission of citations of 
published journal articles, for up to 10 years after completion of the trial.

The draft legislation would allow the secretary of health and human services to 
add to the website "such statements as the Secretary determines to be 
appropriate to assist the public in avoiding misinterpretations of information 
in the data bank."

The secretary would be authorised to conduct compliance audits, with priority 
given to researchers who have been found to be in violation in the past. False 
or misleading information, if not corrected within a specified time period, 
would be subject to substantial fines. Fines would be capped at $15 000 (#8140; 
11 710) for an individual, but for a corporation they could accrue at the rate 
of $10 000 a day until the violation is corrected.

"Consumers shouldn't be left in the dark when it comes to the medications they 
are taking," said Chris Dodd, a Democrat senator for Connecticut, in 
introducing the bill. He is the lead sponsor in the Senate.

"This measure can help shine a bright light on information related to clinical 
trials and, in doing so, help consumers and doctors make more informed 
decisions when it comes to health care."

A member of staff in the House of Representatives who was involved with 
drafting the legislation said recent hearings on the use of antidepressants in 
children had helped to move along the introduction of the bill.

The staff member added that the bill is not likely to be acted on as a separate 
piece of legislation during this term of Congress, though it is possible that a 
supporter will propose it as an amendment to other pending legislation.

The drug industry is unlikely to embrace the proposal. Jeff Truitt, a spokesman 
for the Pharmaceutical Research and Manufacturers of America, said, "The 
pharmaceutical and biotechnology research industry is one of the nation's most 
heavily regulated industries. It would be appropriate if we could avoid yet 
another mandatory regulation."

He argued that the industry's recently unveiled clinical trial database should 
be given a fair chance to work, and he noted that many company trials are 
already registered at the National Institutes of Health's website.



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