Intended for healthcare professionals

News Roundup [abridged Versions Appear In The Paper Journal]

Law is introduced in US Congress to give access to details of clinical trials

BMJ 2004; 329 doi: https://doi.org/10.1136/bmj.329.7473.996-d (Published 28 October 2004) Cite this as: BMJ 2004;329:996
  1. Bob Roehr
  1. Washington, DC

    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 (http://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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