E-DRUG: Fair Access to Clinical Trials Act
[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]
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.