Kenneth A. Getz
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During the past two years, we have been enamored with the disclosure of trial information online. All stakeholders—among them
the pharmaceutical industry, medical journal editors, the American Medical Association, the Association of American Medical
Colleges, patient advocacy groups, the U.S. Congress, and the World Health Organization—actively and openly support improving
information transparency and disclosure. What specifically is disclosed, how it is disclosed, and how to ensure compliance
are the issues now stoking the flames of debate.
Under the 1997 FDA Modernization Act, disclosure of clinical trial information for serious or life-threatening conditions
on clinicaltrials.gov/ has been required of all research sponsors. Yet compliance and enforcement of this nearly decades-old mandate has been lax.
Heightened attention and urgent debate around clinical trial and trial results registries has been prompted most recently
by serious allegations that the lack of transparency and accountability, and the appearance of concealment, has compromised
patient safety and public health. Recently, in an effort to stimulate higher levels of compliance, the International Committee
of Medical Journal Editors began requiring that sponsors register their clinical trials, before enrollment of the first patient,
as a condition of consideration for publication in major peer-reviewed journals. Legislators want to go even further by forcing
sponsors to publicly post the details of their clinical trials, including results, on the National Library of Medicine's Web
site (clinicaltrials.gov/). Some have suggested that the failure to do so should carry substantial monetary penalties.
At the center of the "trial transparency" debate is whether or not disclosure is best accomplished via either one central
registry—with clinicaltrials.gov/ the seemingly obvious choice—or at many different online locations. More than 1500 organizations —including private sector
research sponsors, investigative sites, general and health information publishers, and disease-specific groups—are now listing
clinical trials on the Internet, and the rate of proliferation of these autonomous Web sites is accelerating.
Although disclosure and transparency of clinical research information via online registries is primarily intended for use
by the public, to date the debate has not had input from the public and patient communities. Shamefully, no one has bothered
to inquire what registry users think about all of this. Had they asked, they would learn that the public isn't concerned about
the volume and sophistication of clinical trials data they can find online. What the public wants is easy access to summary
information and some sense of what to do once they find it. In the absence of information on the attitudes and behaviors of registry users, The Center for Information and Study on Clinical
Research Participation (CISCRP)—a nonprofit organization—conducted an online survey in late 2005 among nearly 5000 registry
users. This initial CISCRP study begins to amplify a voice that is too often unheard and forgotten. It is critically important
that clinicaltrials.gov/ and other well-established publishers of registries also make efforts to share what they have learned about their users to
better inform the debate.
Multi- or single sources sought
According to the CISCRP survey, at this time the public does not want a single registry. They don't trust one source for information—regardless
of whether a government or private-sector organization is sponsoring the site. Users would prefer to browse multiple locations
to support their desire to self-advocate their health care decisions. Eventually, registry users want the convenience offered
by a single source—but their trust in that source needs to be better established.
