Print version ISSN 0042-9686
Bull World Health Organ vol.84 n.6 Genebra Jun. 2006
No delayed disclosure for registration of clinical trials
In a major step towards making clinical trials more transparent and publicly accountable, WHO unveiled the disclosure rules for pharmaceutical companies and others when they register trials they are planning with human participants under the International Clinical Trials Registry Platform initiative.
WHO said on 19 May that there would be no delayed disclosure of any of the 20 key details that companies or other research institutions need to submit when they register clinical trials. WHO called on these research institutions to register all clinical trials prior to enrolment, regardless of the type of study, as participation for these institutions is voluntary.
WHO has already announced the 20-item data set (see box on opposite page), which must be provided when a trial is registered under the initiative.
The decision on disclosure rules comes after two years of consultations, culminating in a 26 April meeting with representatives from the pharmaceutical, biotechnology and device industries; patient and consumer groups; governments; medical journal editors; ethics committees; and academia.
During those consultations some groups raised concerns that academic or commercial competitive advantage could be jeopardized by the immediate disclosure when a trial is registered of five of the 20 items: the name of the intervention(s) tested; the primary outcome; key secondary outcomes; the target sample size; and the scientific title for registered trials.
But in the end, WHO concluded that registration and immediate disclosure of registered data prior to recruiting participants for all clinical trials including early trials involving patients or healthy volunteers were the only way to ensure transparency and fulfil ethical responsibilities to patients and study participants.
Commenting on the decision, Dr An-Wen Chan, who is helping coordinate the project at WHO, said: "This is a major step forward. We hope it will contribute significantly to making clinical trials more transparent and to enhancing public trust in science.
The clinical trials initiative comes in response to a growing chorus of scientists, academic leaders and editors of top medical journals calling for new standards and rules for the registration of all clinical trials, i.e. studies in which treatments are tested on humans.
Currently, there are several hundred registers of clinical trials around the world but little coordination among them. The WHO International Clinical Trials Registry Platform is a major initiative to bring participating registers together in a global network to provide a single point of access to the information stored in them.