May 29, 2002
NEW YORK (Reuters Health)
Web sites that provide listings of clinical trials are growing in popularity, but a new US government inspection reveals a potential danger for patients.
None of the sites visited by federal inspectors disclose the risks of participating in a study, while less than a third give the names of the trial sponsors.
Such omissions may leave patients with false impressions, undermining the informed consent process, the Department of Health and Human Services Office of Inspector General (OIG) cautioned in a report issued Tuesday afternoon.
The OIG urges the US Food and Drug Administration (FDA) and the federal Office for Human Research Protections (OHRP) to work together to produce a common set of expectations to help ensure the credibility of clinical trials Web sites.
Federal inspectors reviewed 22 clinical trials Web sites and 110 listings on those sites. The examination includes three federal Web sites as well as a number of third-party Web sites and sites run by institutional and pharmaceutical sponsors. They also interviewed Web site sponsors, federal officials and members of institutional review boards (IRBs), whose responsibility is to protect the welfare of trial participants.
While 29 Web sites present the benefits of participating in a trial, none describe the risks, it found. Moreover, most of the benefits focus on convenience and incentives, such as free parking and payment for participation in a trial, not the clinical aspects of the trial.
"These benefits can be misleading if not tempered by a statement that risks are involved," the report notes.
A majority (63%) of sites did not indicate the phase of the clinical trial, making it impossible for a patient to distinguish a phase I trial that is designed strictly to test the safety of an experimental drug from a phase III trial focusing on efficacy and safety, it said. A general description of the protocol was missing from 51% of the sites reviewed.
The report offers several examples of information that overstated the benefits of a clinical trial.
Another area of concern involved lapses in Web site privacy policies. Of the 13 sites that collect personal information from visitors, most do not disclose how they will use the information, the OIG reported.
And while 12 sites generate revenue, half of them fail to disclose how they do so. Financial relationships can affect how a site's information is interpreted, the report said.
The FDA and OHRP should foster the development of voluntary standards for clinical trials Web sites and encourage Web sites to voluntarily submit to periodic review by an IRB or accrediting organization, the OIG said.
Those agencies also should stipulate that risk and benefit information
in clinical trial listings and any prescreening information collected from
individuals for specific trials is subject to IRB review and approval,
© 2002 Reuters Ltd