The World Health Organization (WHO) last month urged research institutions
and pharmaceutical companies around the world to register all medical studies
that test treatments on human beings, including the earliest phase of
research, whether they involve patients or healthy volunteers.
The initiative—known as the International Clinical Trials Registry
Platform— is framed around a set of 20 "key details" that
must be disclosed at the time a study begins and is aimed at standardizing the
way information on medical studies is made available to the public.
"Registration of all clinical trials and full disclosure of key
information at the time of registration are fundamental to ensuring
transparency in medical research and fulfilling ethical responsibilities to
patients and study participants," said Timothy Evans, M.D., assistant
director-general of WHO.
Paul Appelbaum, M.D., a former APA president and director of the Division
of Psychiatry, Law, and Ethics at Columbia University College of Physicians
and Surgeons, agreed that registration of all clinical trials is a"
critical step," one that would help assure "the integrity
of the research process." He added that comprehensive, advance
registration of clinical trials would accomplish several goals.
"Not only does advance specification of outcome measures limit the
potential for post facto manipulation of data, but public knowledge of every
trial under way means that negative studies cannot go unacknowledged,"
Appelbaum told Psychiatric News. "Physicians and patients are
thus more likely to have access to the full array of information about
medications before making prescribing decisions."
Appelbaum also noted APA's long-standing commitment to transparency in
clinical research. APA has been at the forefront of the issue, advocating for
mandatory registration of all clinical trials and ensuring researchers'
unencumbered rights to publication of all results from those trials. In 2002
APA looked favorably on calls for requiring that clinical trials be registered
in order for their results to be published in peer-reviewed journals
(Psychiatric News, February 1, 2002). In 2004 APA joined the American
Academy of Child and Adolescent Psychiatry and others in winning approval of a
new AMA policy calling for federal legislation mandating registry of all
clinical trials (Psychiatric News, July 16, 2004).
The WHO Registry Platform is not a clinical trials register itself, but
rather provides a set of standards for all registries around the world to use.
Use of the standards is voluntary. The initiative not only aims to standardize
what must be reported to register a clinical trial, but also will create a
global trial identification system that will issue a standardized unique
reference number for every qualified trial.
Currently, there are several hundred registries of clinical trials around
the world, but little coordination among them. In the United States the
predominant registry is the National Library of Medicine's<www.clinicaltrials.gov>.
However, registration requirements for this site differ from WHO's (see
Other countries have also formed voluntary registries as well, including
Canada, United Kingdom, Germany, Japan, and Australia. In addition, many large
pharmaceutical companies have developed online registries devoted to their own
Individual companies and institutions can adopt the new WHO standards at
any time. While no countries have announced adoption yet, a WHO spokesperson
noted that there is a vocal group of supporters calling on the United Nations
to adopt the registry platform as a mandatory requirement of human research.
Under current treaties, the spokesperson confirmed, a U.N.-mandated registry
platform could be legally required for all sponsors initiating clinical trials
in any U.N. member country.
Later this year, the WHO registry will launch a Web-based search portal
through which scientists, patients, doctors, donors, and others can search
among participating registers for clinical trials taking place or completed
throughout the world.
WHO is recommending that 20 key details be disclosed at the time studies
are begun. Basic identification information includes the primary registry in
which the trial is registered and the identification number of the trial with
that registry. In addition, source of funding, primary and secondary sponsors,
and both the public and scientific titles of each clinical trial must be
The WHO initiative also calls for disclosure of more specific trial
information up front: The health condition(s) being studied, the specific
intervention(s) being studied, key inclusion and exclusion criteria, and the
primary and secondary outcomes to be measured.
WHO administrators said the initiative seeks to respond to growing public
demands for transparency regarding all studies applying interventions to human
"Our aim is to make clinical research transparent and enhance public
trust in science, but we are engaged in a fair and open process with all
stakeholders. We look forward to continued dialogue about trial registration
and results reporting as we move forward with the registry platform,"
said Ida Sim, Ph.D., the associate director for medical informatics at the
University of California, San Francisco, and coordinator of the WHO Registry
Before making the recommendations, the WHO initiative involved consultation
over a period of nearly two years with a wide array of concerned stakeholders,
including representatives from the pharmaceutical, biotechnology, and medical
device industries; patient and consumer groups; governments; medical journal
editors; ethics committees; and academia.
Some groups have raised concerns that the proposed requirements could
jeopardize academic or commercial competitive advantage if they apply to
preliminary trials of new interventions. Similar concerns have been voiced
about the requirement to disclose certain items—such as the scientific
title of the study, the specific name of the treatment being tested, and the
outcomes expected from the study—at the time of registration.
WHO officials pointed out, however, that if all sponsors disclose all 20
key details outlined by the registry platform, no sponsor is left with a
competitive advantage because the standards for disclosure are uniform.
More information on the WHO initiative is posted at<www.who.int/ictrp/en/>.▪