Clinical Trial Listings and Results Go Public
Next step: Open access Efforts to list all clinical trials and study
results in a national database mesh with the related initiative to
increase public access to government-funded research results. In July,
the House Appropriations committee added language to the 2005 HHS
funding bill calling for NIH to develop a system for public posting of
articles about NIH-funded research. Such articles usually are published
in expensive professional journals and may take months to appear.
Last month NIH responded by proposing to require researchers to submit
to a new NIH database all papers based on NIH research that have been
accepted for journal publication. NIH will post articles six months
after publication, so publishers and medical societies have the
opportunity to profit from their vetting and publishing activities.
Medical journal editors protest that the NIH plan will reduce
subscriptions and income, and researchers are concerned that open access
would translate into an "author-pays" business model. NIH is accepting
comments on the open access plan through November.
Observers remain skeptical that industry's voluntary efforts will be
enough. PhRMA intends to use an independent third party to manage and
oversee its database, and says that it has "extremely strong commitment"
to the program from top company executives, said Caroline Loew, vice
president for scientific and regulatory affairs.
PhRMA's main message to legislators is that its initiative will provide
access to data immediately, while a legislative route could take years.
It remains to be seen if industry will continue to make public
previously private information after the spotlight shifts to another
medical research issue.
SIDEBAR: FDA Finds Poor Compliance with Trial Registration Program
To implement FDAMA, the National Library of Medicine (NLM) established
the ClinicalTrials.gov database in February 2000, by incorporating
cancer and AIDS databases established by the National Institutes of
Health (NIH). The site now lists about 10,600 trials and attracts 16,000
visitors daily. But less than 10% of protocols come from sponsors of
To encourage industry to post trials on the Web site, FDA issued
guidance in 2002 that clarifies which studies should be listed and
procedures for doing so. FDA's Office of Special Health Issues (OSHI)
launched an educational program and sent letters to some 3000 sponsors
of INDs (investigational new drug applications) for drugs and biologics
to determine which studies involved treatments for life-threatening
diseases and thus should be listed.
As of June 2004, though, 246 pharmaceutical companies had listed only
about 1200 protocols. Moreover, many of the listings are incomplete,
often missing critical information on study sites or drug or company
name. An OSHI review of all cancer protocols submitted to FDA's Center
for Drug Evaluation and Research (CDER) during nine months in 2002 shows
industry's poor compliance record: of 366 cancer protocols submitted to
FDA, 127 were sponsored by drug companies and met the criteria for
listing on ClinicalTrials.gov. However, less than half (48%) of the
eligible industry studies were listed, compared to 91% of eligible NIH
trials. And OSHI's analysis indicates that cancer and AIDS trials are
the best-reported of all disease areas.
Pharma companies have claimed that trial registration could reveal
proprietary information, such as inclusion/exclusion criteria and site
locations. But FDA staffers maintain that such facts usually are well
known by market analysts by the time a drug moves into Phase II or III
studies. Conversely, regulators believe that registration provides an
invaluable way for sponsors to accelerate patient enrollment in trials
and to avoid duplicative research. OSHI is finalizing its report on
registry compliance, which may lead to revisions in eligibility criteria
and posting procedures.-J.W.