In a bold undertaking, the editors of some of the world's most prestigious
peer-reviewed medical journals announced in September that they will"
require, as a condition of consideration for publication, registration
in a public trials registry" for all articles written about clinical
trials. The announcement moves an APA goal one step closer to fruition.
The group of 11 editors, known as the International Committee of Medical
Journal Editors (ICMJE), said that for any clinical trial that starts
enrollment after July 1, 2005, the trial must register "at or before the
onset of patient enrollment." For trials that begin enrollment prior to
that date, registration will be required as a condition of consideration for
publication as of September 13, 2005.
"In return for the altruism and trust that make clinical research
possible," the ICMJE editors (see box below) wrote, "the research
enterprise has an obligation to conduct research ethically and to report it
honestly. Honest reporting begins with revealing the existence of all clinical
studies, even those that reflect unfavorably on a research sponsor's
"Unfortunately," the editors continued, "selective
reporting of trials does occur, and it distorts the body of evidence available
for clinical decision making."
The ICMJE defined a clinical trial as "any research project that
prospectively assigns human subjects to intervention or comparison groups to
study the cause-and-effect relationship between a medical intervention and a
The ICMJE did not dictate trial registration in a specific registry,
instead delineating the principles it believes a registry should meet. The
registry should be independently managed by a nonprofit organization and must
be open to all registrants and freely accessible to the public. In addition,
the editors said, there must be some mechanism for ensuring the validity of
the information, and the database should be electronically searchable. The
editors also created a comprehensive list of minimal data that should be
contained in the registry record.
Currently, the only clinical trials database that will satisfy the ICMJE
requirements is the National Library of Medicine's<www.clinicaltrials.gov>.
In recent months, several pharmaceutical companies said they will begin
listing their clinical trials data on their own Web sites. Last month, during
a congressional hearing on alleged withholding of negative clinical trials
data involving antidepressants, the drug industry's trade group, the
Pharmaceutical Research and Manufacturers of America, announced it would
develop an online registry "to improve the transparency of the drug
In addition, several members of the House of Representatives and Senate
have announced that they are working to introduce legislation mandating a
federally administered clinical trials registry.
All of the current efforts follow the advocacy efforts of APA and the
American Academy of Child and Adolescent Psychiatry (AACAP). In June 2003 APA
and AACAP jointly introduced a resolution at the AMA's House of Delegates
asking the AMA to support and advocate for a registry. That resolution led to
a report on the issue by the AMA's Council on Scientific Affairs. Last June,
an APA/AACAP joint resolution was finally approved, cementing AMA's support of
a formal clinical trials registry.
As this article went to press, the editorial board of the American
Journal of Psychiatry was expected to review the ICMJE statement. While
AJP and the other journals published by American Psychiatric
Publishing Inc. are not members of ICMJE, the journals have historically
conformed to ICMJE policy.
The ICMJE's statement on clinical trials registry can be accessed
by clicking on "Clinical Trials Registry" under "ICMJE