Bulletin of the World Health Organization

WHO clinical trials initiative to protect the public

In response to calls for new standards and rules for the registration of studies involving humans participants, WHO is developing a common set of rules for registering clinical trials.

The picture shows a group of children in Colombia who are queueing up to be given a malaria vaccine in a clinical trial in the 1990s.
WHO/TDR/O. Martel
Millions of people around the world participate in clinical trials and are affected by the results of those trials.

WHO plans to launch a global network of clinical trial registers in May 2006, the first step towards establishing a web-based search platform where members of the public can obtain full and detailed information about clinical trials.

Currently, there are at least 50 registers of clinical trials around the world. The WHO International Clinical Trials Registry Platform is a major initiative to bring these registers together in a global network to provide a single point of access to the information stored in them.

The goal is to increase transparency and accountability on the part of companies and institutions that do clinical research, and, in turn, boost public trust and confidence in that research.

“Registration of trials promotes scientific and ethical integrity and makes research more honest. When the system is up and running there will be no hiding of results,” said Dr Patrick Unterlerchner, WHO Health Systems Analyst and Assistant to the Coordinator of the project.

The initiative comes in the wake of several cases of companies withholding negative research findings that sparked public outrage. Merck of the United States withdrew Vioxx from the market in 2004 after the drug was linked to an increased risk of heart attack and stroke, and in 2003, GlaxoSmithKline of the United Kingdom warned that the antidepressant, Paxil, should not be prescribed to minors as it could increase the risk of suicide.

In response, the International Committee of Medical Journal Editors (ICMJE), representing the world’s leading medical journals, agreed not to publish the results of any clinical trial unless that trial had been registered in a public register before the enrolment of the first patient.

One of the largest registers, ClinicalTrials.gov, which is hosted by the US National Institutes of Health, contains some 23 000 registered trials, while the International Standard Randomised Controlled Trial Number Register in the United Kingdom contains some 3500.

These registers hold mainly information about trials done in the developed world. A number of countries, including some from the developing world, have plans to start their own registers.

“There is a clear need to consolidate all information on clinical trials to use resources efficiently and reduce the chances that a trial might be registered in more than one register,” Unterlerchner said. He argued that WHO is best placed to do this as a global body representing 192 Member States that is able to set norms and standards in research, policy and practice.

WHO does not plan to set up its own clinical trials register. The idea is for WHO to set rules and standards on how existing registers should operate and how they should work together.

WHO plans to bring all the registers meeting these standards into a global register network, searchable on one WHO search portal. The portal will give sick people the chance to find out about research into their particular disease and to ask their doctors to enrol them in a clinical trial that may offer them access to innovative treatments that are not yet widely available. http://www.who.int/ictrp